Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04776720
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2021-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ancillary Study of the Lessening Incontinence With Low-impact Activity Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alison.huang@ucsf.edu', 'phone': '415-353-7900', 'title': 'Alison Huang, MD, MAS, MPhil', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '9 months', 'eventGroups': [{'id': 'EG000', 'title': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.\n\nYoga Practice Program: 3 month group yoga classes', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 37, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.\n\nPhysical Conditioning Program: 3 month group physical conditioning classes', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 43, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Recurrent Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Detached Retina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Abdominal Cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dental Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Epigastric Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Food Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Tooth Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Facial Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Allergy Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hay Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bladder Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Coronavirus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lower Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Mumps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Tooth Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Back Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Epicondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Knee Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lateral Epicondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Leg Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Muscle Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pulled Hamstring', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Shoulder Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Toe Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vaccination Adverse Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Colonoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Endoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Back Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Back Pain; Knee Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Foot Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Frozen Shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Groin Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hand Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hip Arthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hip Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Knee Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Knee Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Leg Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Low Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lumbar Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Muscle Soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pain Ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pain In Ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pain In Elbow', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pain In Hip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Patellofemoral Pain Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Rotator Cuff Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Shoulder Deformity Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Shoulder Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Shoulder Soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Spinal Disorder Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Melanoma In Situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cervical Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Localised Numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Migraine, Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Neck Numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Sciatica Aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Asthma Aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Asthmatic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Shortness Of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cyst Epidermal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Neck Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Back Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bladder Sling Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bunionectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Knee Arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Oral Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Shoulder Replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hot Flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'High Grade B-Cell Lymphoma Burkitt-Like Lymphoma Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in One-legged Balance Test (Winsorized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.\n\nYoga Practice Program: 3 month group yoga classes'}, {'id': 'OG001', 'title': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.\n\nPhysical Conditioning Program: 3 month group physical conditioning classes'}], 'classes': [{'categories': [{'measurements': [{'value': '1.34', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '2.16'}, {'value': '1.53', 'groupId': 'OG001', 'lowerLimit': '0.72', 'upperLimit': '2.35'}]}]}], 'analyses': [{'pValue': '0.743', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Model based LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '1.34', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in successive semi-tandem, tandem, and one-legged balance stand tests, in which their ability to hold each position for up to 30 seconds. Scoring is based on the number of seconds in which the participant is able to hold the one-legged balance position, ranging from 0 to 30. If a participant cannot make it through the semi-tandem and tandem stands, the one-legged balance will not be attempted. They will receive a score of zero for the one-legged balance.\n\nChange was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points', 'unitOfMeasure': 'seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with outcomes data'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Chair Stands (in 30 Seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.\n\nYoga Practice Program: 3 month group yoga classes'}, {'id': 'OG001', 'title': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.\n\nPhysical Conditioning Program: 3 month group physical conditioning classes'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.32', 'upperLimit': '1.68'}, {'value': '1.98', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '2.66'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Model based LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.03', 'ciUpperLimit': '1.93', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points.\n\nHigher score indicates better quality of life', 'unitOfMeasure': 'chair stands', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with outcomes data'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in 2-Minute Step Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.\n\nYoga Practice Program: 3 month group yoga classes'}, {'id': 'OG001', 'title': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.\n\nPhysical Conditioning Program: 3 month group physical conditioning classes'}], 'classes': [{'categories': [{'measurements': [{'value': '8.05', 'groupId': 'OG000', 'lowerLimit': '4.58', 'upperLimit': '11.51'}, {'value': '9.03', 'groupId': 'OG001', 'lowerLimit': '5.59', 'upperLimit': '12.48'}]}]}], 'analyses': [{'pValue': '0.689', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Model based LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '-3.87', 'ciUpperLimit': '5.84', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline value Repeated measures mixed models, with variance co-variance matrix'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in aerobic endurance. In this test of aerobic endurance for older adults, participants are asked to step in place as many times as possible in a 2 minute period, each time raising the knee to a level midway between the patella and iliac crest.\n\nChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Higher scores indicating greater endurance.', 'unitOfMeasure': 'steps', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with outcomes data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Perceived Stress Scale (PSS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.\n\nYoga Practice Program: 3 month group yoga classes'}, {'id': 'OG001', 'title': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.\n\nPhysical Conditioning Program: 3 month group physical conditioning classes'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.44', 'groupId': 'OG000', 'lowerLimit': '-1.41', 'upperLimit': '0.52'}, {'value': '-0.72', 'groupId': 'OG001', 'lowerLimit': '-1.68', 'upperLimit': '0.24'}]}]}], 'analyses': [{'pValue': '0.685', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Model based LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-1.63', 'ciUpperLimit': '1.07', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in total score on Perceived Stress Scale (PSS), a 10-item measure of thoughts and feelings related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40; higher scores indicated greater perceived stress.\n\nChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with outcomes data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.\n\nYoga Practice Program: 3 month group yoga classes'}, {'id': 'OG001', 'title': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.\n\nPhysical Conditioning Program: 3 month group physical conditioning classes'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.82', 'groupId': 'OG000', 'lowerLimit': '-2.25', 'upperLimit': '0.6'}, {'value': '-0.52', 'groupId': 'OG001', 'lowerLimit': '-1.93', 'upperLimit': '0.9'}]}]}], 'analyses': [{'pValue': '0.764', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Model based LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '2.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in total score on Center for Epidemiologic Studies Depression (CES-D) scale, a validated 20-item self-administered questionnaire measure that has been widely used in clinical trials, including trials of bladder interventions, and has been shown to be sensitive to change. Total scores range from 0 to 60, with higher scores indicate greater burden of depression symptoms.\n\nChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with outcomes data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.\n\nYoga Practice Program: 3 month group yoga classes'}, {'id': 'OG001', 'title': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.\n\nPhysical Conditioning Program: 3 month group physical conditioning classes'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.22', 'groupId': 'OG000', 'lowerLimit': '-2.41', 'upperLimit': '-0.03'}, {'value': '-1.34', 'groupId': 'OG001', 'lowerLimit': '-2.52', 'upperLimit': '-0.17'}]}]}], 'analyses': [{'pValue': '0.883', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Model based LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-1.78', 'ciUpperLimit': '1.53', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in somatic anxiety. Somatic anxiety (i.e., the affective component of anxiety believed to be related to autonomic physiological arousal response) is measured using the trait component of the Spielberger State Trait Anxiety Inventory (STAI), a 20-item self-administered measure validated in clinical populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.\n\nChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with outcomes data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.\n\nYoga Practice Program: 3 month group yoga classes'}, {'id': 'OG001', 'title': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.\n\nPhysical Conditioning Program: 3 month group physical conditioning classes'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'groupId': 'OG000', 'lowerLimit': '-0.72', 'upperLimit': '0.3'}, {'value': '-0.33', 'groupId': 'OG001', 'lowerLimit': '-0.83', 'upperLimit': '0.18'}]}]}], 'analyses': [{'pValue': '0.753', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Model based LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '0.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. Range 0-21, Higher score indicates lower quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with outcomes data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Wake After Sleep Onset (Winsorized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.\n\nYoga Practice Program: 3 month group yoga classes'}, {'id': 'OG001', 'title': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.\n\nPhysical Conditioning Program: 3 month group physical conditioning classes'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.55', 'groupId': 'OG000', 'lowerLimit': '-7.96', 'upperLimit': '0.85'}, {'value': '-6.96', 'groupId': 'OG001', 'lowerLimit': '-11.3', 'upperLimit': '-2.61'}]}]}], 'analyses': [{'pValue': '0.276', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Model based LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-9.54', 'ciUpperLimit': '2.74', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in sleep disruption. Average time spent awake after initial sleep onset is also assessed using the Pittsburgh Sleep Diary, based on participant recordings of nocturnal awakenings after initially falling asleep.\n\nChange was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates lower quality of life.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with outcomes data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.\n\nYoga Practice Program: 3 month group yoga classes'}, {'id': 'OG001', 'title': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.\n\nPhysical Conditioning Program: 3 month group physical conditioning classes'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.37', 'groupId': 'OG000', 'lowerLimit': '-0.78', 'upperLimit': '0.04'}, {'value': '-0.66', 'groupId': 'OG001', 'lowerLimit': '-1.07', 'upperLimit': '-0.25'}]}]}], 'analyses': [{'pValue': '0.319', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Model based LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '0.28', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in global sleep quality. Subjective sleep quality is being assessed using the Pittsburgh Sleep Quality Index (PSQI), an 18-item validated questionnaire originally designed to assess sleep quality, latency, efficiency, and problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality.\n\nChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with outcomes data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.\n\nYoga Practice Program: 3 month group yoga classes'}, {'id': 'OG001', 'title': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.\n\nPhysical Conditioning Program: 3 month group physical conditioning classes'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '0.17'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '-0.08', 'upperLimit': '0.27'}]}]}], 'analyses': [{'pValue': '0.448', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Model based LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.34', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in average nightly sleep duration. Average total sleep duration is assessed using the Pittsburgh Sleep Diary is a daily self-report measure previously validated against actigraphy data, and used in multiple past studies of older adults.\n\nChange from baseline in Total sleep time. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with outcomes data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.\n\nYoga Practice Program: 3 month group yoga classes'}, {'id': 'FG001', 'title': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.\n\nPhysical Conditioning Program: 3 month group physical conditioning classes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'COVID Related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Too Busy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Family', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'No remote technology access', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Cannot tolerate intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Incomplete outcome data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.\n\nYoga Practice Program: 3 month group yoga classes'}, {'id': 'BG001', 'title': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.\n\nPhysical Conditioning Program: 3 month group physical conditioning classes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '61.4', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '8.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or PI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'American Indian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Urinary Incontinence Episodes', 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '3.2', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'episodes per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stress-Type Urinary Incontinence Episodes', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '1.4', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '1.4', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'episodes per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urgency-Type Urinary Incontinence Episodes', 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '1.9', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'episodes per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Incontinence Impact Questionnaire (IIQ)', 'classes': [{'categories': [{'measurements': [{'value': '100.4', 'spread': '78.9', 'groupId': 'BG000'}, {'value': '101.6', 'spread': '66.4', 'groupId': 'BG001'}, {'value': '101.0', 'spread': '72.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Range 0-400, Higher score indicates lower quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urogenital distress inventory-6 score (UDI)', 'classes': [{'categories': [{'measurements': [{'value': '39.1', 'spread': '19.1', 'groupId': 'BG000'}, {'value': '28.5', 'spread': '19.4', 'groupId': 'BG001'}, {'value': '38.8', 'spread': '19.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Range 0-100, Higher score indicates lower quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Perception of BladderCondition (PPBC)', 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '3.4', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Range 1-6, Higher score indicates lower quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Center for Epidemiologic Studies Depression Scale (CES-D)', 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '10.0', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '10.0', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Range 0-60, Higher score indicates lower quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'State/Trait Anxiety Inventory (STAI)--Trait', 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '36.1', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '36.1', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Range 20-80, Higher score indicates lower quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hospital Anxiety & Depression (HADS)--Anxiety score', 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '5.2', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Range 0-21, Higher score indicates lower quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Perceived Stress Scale (PSS) score', 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '13.3', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '13.2', 'spread': '7.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Range 0-40, Higher score indicates lower quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PROMIS Physical 8B, T-Score', 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '51.3', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '51.2', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '(mean 50, Std Dev 10) no widely accepted thresholds have been published Higher score indicates better quality of life', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'One-legged Balance Test', 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '25.5', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '24.9', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Range 0-30, Higher score indicates better quality of life', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Chair Stands (in 30 seconds)', 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '13.1', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '12.9', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Higher score indicates better quality of life', 'unitOfMeasure': 'chair stands', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '2-Minute Step Test', 'classes': [{'categories': [{'measurements': [{'value': '85.9', 'spread': '22.8', 'groupId': 'BG000'}, {'value': '88.5', 'spread': '26.1', 'groupId': 'BG001'}, {'value': '87.2', 'spread': '24.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Higher score indicates better quality of life', 'unitOfMeasure': 'steps', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Wake after sleep onset', 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '29.2', 'groupId': 'BG000'}, {'value': '25.2', 'spread': '25.6', 'groupId': 'BG001'}, {'value': '24.8', 'spread': '27.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Higher score indicates lower quality of life', 'unitOfMeasure': 'Minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total sleep time', 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '7.0', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '7.0', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Higher score indicates better quality of life', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pittsburgh Sleep Quality Index (PSQI) total score', 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '6.6', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '6.4', 'spread': '3.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Range 0-21, Higher score indicates lower quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-10', 'size': 333585, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-01T13:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2021-02-25', 'resultsFirstSubmitDate': '2023-07-05', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-29', 'studyFirstPostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in One-legged Balance Test (Winsorized)', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in successive semi-tandem, tandem, and one-legged balance stand tests, in which their ability to hold each position for up to 30 seconds. Scoring is based on the number of seconds in which the participant is able to hold the one-legged balance position, ranging from 0 to 30. If a participant cannot make it through the semi-tandem and tandem stands, the one-legged balance will not be attempted. They will receive a score of zero for the one-legged balance.\n\nChange was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points'}, {'measure': 'Change From Baseline in Chair Stands (in 30 Seconds)', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points.\n\nHigher score indicates better quality of life'}, {'measure': 'Change From Baseline in 2-Minute Step Test', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in aerobic endurance. In this test of aerobic endurance for older adults, participants are asked to step in place as many times as possible in a 2 minute period, each time raising the knee to a level midway between the patella and iliac crest.\n\nChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Higher scores indicating greater endurance.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Perceived Stress Scale (PSS) Score', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in total score on Perceived Stress Scale (PSS), a 10-item measure of thoughts and feelings related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40; higher scores indicated greater perceived stress.\n\nChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points'}, {'measure': 'Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in total score on Center for Epidemiologic Studies Depression (CES-D) scale, a validated 20-item self-administered questionnaire measure that has been widely used in clinical trials, including trials of bladder interventions, and has been shown to be sensitive to change. Total scores range from 0 to 60, with higher scores indicate greater burden of depression symptoms.\n\nChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points'}, {'measure': 'Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in somatic anxiety. Somatic anxiety (i.e., the affective component of anxiety believed to be related to autonomic physiological arousal response) is measured using the trait component of the Spielberger State Trait Anxiety Inventory (STAI), a 20-item self-administered measure validated in clinical populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.\n\nChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points'}, {'measure': 'Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. Range 0-21, Higher score indicates lower quality of life'}, {'measure': 'Change From Baseline in Wake After Sleep Onset (Winsorized)', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in sleep disruption. Average time spent awake after initial sleep onset is also assessed using the Pittsburgh Sleep Diary, based on participant recordings of nocturnal awakenings after initially falling asleep.\n\nChange was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates lower quality of life.'}, {'measure': 'Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in global sleep quality. Subjective sleep quality is being assessed using the Pittsburgh Sleep Quality Index (PSQI), an 18-item validated questionnaire originally designed to assess sleep quality, latency, efficiency, and problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality.\n\nChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points'}, {'measure': 'Change From Baseline in Total Sleep Time', 'timeFrame': 'Repeated change from baseline to 6 and 12 weeks', 'description': 'Assess change in average nightly sleep duration. Average total sleep duration is assessed using the Pittsburgh Sleep Diary is a daily self-report measure previously validated against actigraphy data, and used in multiple past studies of older adults.\n\nChange from baseline in Total sleep time. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '41359336', 'type': 'DERIVED', 'citation': 'Hough E, Goldstein LA, Subak LL, Chesney MA, Schembri M, Raghunathan H, Balys Pawlowsky S, Huang AJ. Effects of Hatha Yoga vs Physical Conditioning on Sleep in Women With Urinary Incontinence: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2546499. doi: 10.1001/jamanetworkopen.2025.46499.'}]}, 'descriptionModule': {'briefSummary': 'The parent trial that supports this ancillary research is a randomized controlled trial to evaluate the efficacy of a group-based yoga intervention to decrease the frequency and impact of urinary incontinence in ambulatory middle-aged and older women.\n\nWomen aged 45 years and older who report daily or more frequent stress-, urgency-, or mixed-type incontinence, are not already engaged in formal yoga or muscle stretching/strengthening programs, are willing to temporarily forgo other clinical treatments for incontinence, are able to walk to and use the bathroom without assistance, and meet other eligibility criteria are being recruited from multiple locations surrounding the San Francisco Bay area. Following a series of telephone- and then clinic-based screening assessments, including a voiding diary to confirm the frequency and clinical type of incontinence, eligible women are randomized in a 1:1 ratio to participate in either a 3-month yoga program (N\\~120) or a time-equivalent, non-specific muscle stretching and strengthening control program (N\\~120).\n\nDuring the 3-month intervention period, participants participate in structured intervention programs (either yoga-specific or muscle stretching-strengthening) consisting of twice weekly, 90-minute group classes led by trained instructors). They are also be instructed to practice their assigned intervention for at least an additional hour per week, with the assistance of participant manuals created by the study team and a set of home yoga or stretching/strengthening exercise props.\n\nFor this ancillary trial research, the investigators are examining ancillary measures of a) physical performance status, b)perceived stress, depression, and anxiety symptoms, and c) sleep quality, duration, and continuity, already incorporated by the principal investigator into the parent trial. The investigators will examine prospective relationships between these ancillary measures and participant-reported urinary incontinence frequency/severity/impact, examine intervention effects on these ancillary outcomes, and assess the extent to which these ancillary outcomes mediate intervention effects on incontinence frequency/severity/impact.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women aged 45 years or older who report urinary incontinence starting at least 3 months prior to screening\n* Self-report an average of at least one incontinence episodes per day voiding diary\n* Self-report urgency-predominant (i.e., at least half of incontinence episodes being urgency-type), stress-predominant (i.e., at least half of episodes being stress-type), or mixed-type (i.e., an equal number of stress- and urgency-type episodes) incontinence on the screening voiding diary\n* Willing to refrain from initiating medical treatments that may affect their incontinence or voiding pattern during the study intervention period\n\nExclusion Criteria:\n\n* Current participation in organized yoga classes or workshops, or any prior organized yoga training directed specifically at improving incontinence\n* Current participation in organized physical conditioning classes involving muscle strengthening exercises (e.g., Pilates)\n* Current urinary tract infection or hematuria detected by urinalysis at screening visit (women can re-present after evaluation and treatment through their usual care)\n* Report use of medical devices (i.e. pessary) for incontinence within the past month (participants may stop use of device and re-present for study)\n* Report use of bladder botox, electrostimulation, formal bladder training, or formal pelvic floor exercise training (with certified practitioners) in the past 3 months\n* Report any history of prior anti-incontinence or urethral surgery (not including urethral dilation), pelvic cancer, or pelvic irradiation\n* Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) within the past 3 months\n* Unable to walk 2 blocks on level ground without assistance (functional capacity \\< 4 metabolic equivalents)\n* Unable to get up from a supine to a standing position without assistance (assessed during the screening visit)\n* Report history of interstitial cystitis, bladder or rectal fistula, or congenital defect causing urinary incontinence\n* Report incontinence caused by a major neurologic conditions such as multiple sclerosis, spinal cord injury, or Parkinson's disease\n* Report use of medications with strong effects on urination (anticholinergic bladder medications, beta-3 agonists, tricyclic antidepressants, mirabegron, loop diuretics) within the past month\n* Report starting, stopping, or changing the dose of a medication with the potential to affect anxiety or depression symptoms (i.e., selective serotonin reuptake inhibitors, anxiolytics/sedatives, antipsychotics) within the past 1 month, or plans to start, stop, or change to dose of such a medication during the study period\n* Participation in another research study that involves investigational drugs or devices that could potentially confound the results of this study\n* Unable to understand study procedures, complete study interviews, or and provide informed consent in English\n* Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol, including plans to move, substance abuse, significant psychiatric problems, or dementia"}, 'identificationModule': {'nctId': 'NCT04776720', 'briefTitle': 'Ancillary Study of the Lessening Incontinence With Low-impact Activity Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Ancillary Study of a Randomized Controlled Trial of a Group Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women', 'orgStudyIdInfo': {'id': 'K24AG068601', 'link': 'https://reporter.nih.gov/quickSearch/K24AG068601', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R01DK116712-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK116712-01A1', 'type': 'NIH'}, {'id': 'K24AG068601', 'link': 'https://reporter.nih.gov/quickSearch/K24AG068601', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yoga Program', 'description': 'The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.', 'interventionNames': ['Behavioral: Yoga Practice Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical Conditioning Program', 'description': 'The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.', 'interventionNames': ['Behavioral: Physical Conditioning Program']}], 'interventions': [{'name': 'Yoga Practice Program', 'type': 'BEHAVIORAL', 'description': '3 month group yoga classes', 'armGroupLabels': ['Yoga Program']}, {'name': 'Physical Conditioning Program', 'type': 'BEHAVIORAL', 'description': '3 month group physical conditioning classes', 'armGroupLabels': ['Physical Conditioning Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Alison Huang, MD, MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}