Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-04 @ 6:01 PM
Study NCT ID:
NCT02942992
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2016-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementing Resistance Exercise to Reduce Frailty for Older Adult
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2016-10-04', 'studyFirstSubmitQcDate': '2016-10-21', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with frailty or pre-frailty as assessed by the SHARE-FI', 'timeFrame': '26 weeks'}], 'secondaryOutcomes': [{'measure': 'Scores of self-reported overall health as measured by the PROMIS-global health', 'timeFrame': '26 weeks'}, {'measure': 'Quadriceps muscle strength as assessed by the 30 second chair rise test', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '29696165', 'type': 'DERIVED', 'citation': 'Danilovich MK, Diaz L, Ciolinio JD, Corcos DM. Functional resistance activities to impact frailty: A protocol for a randomized controlled trial involving home care aide and frail older adult dyads. Contemp Clin Trials Commun. 2017 May 12;7:28-32. doi: 10.1016/j.conctc.2017.05.006. eCollection 2017 Sep.'}]}, 'descriptionModule': {'briefSummary': 'To develop an intervention specifically targeted for these clients who have the frailty syndrome. The Investigators propose to develop an exercise intervention that can reduce frailty in older adults to facilitate their ability to age-in-place. The long-term objective of this work is to develop a package of interventions that can be administered within the existing Medicaid Home and Community Based Services (HCBS) Waiver programs. The specific goal of this proposal is to develop a resistance exercise intervention to reduce frailty in older adults receiving long term care services in their home through the Illinois Community Care Program, a HCBS Waiver Program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria for Home Care Aides:\n\n\\- Employees of Help at Home, with one eligible client\n\nInclusion criteria for clients:\n\n* aged 65+ years\n* receive HCA services two or more days per week\n* English-speaking\n* not currently participating in regular exercise as defined as 30 minutes three or more days per week, - - no health problems that contraindicate participation in exercise based on the EASY: Exercise Assessment and Screening for You\n* Telephone Interview for Cognitive Status score \\> 26\n\nExclusion criteria for HCAs:\n\n\\- no clients who enroll in the study\n\nExclusion criteria for clients:\n\n* legally blind, no voluntary extremity movement\n* physician does not provide clearance for participation\n* classified as non-frail based on the SHARE-FI frailty testing\n* Telephone Cognitive Status score \\< 25.'}, 'identificationModule': {'nctId': 'NCT02942992', 'briefTitle': 'Implementing Resistance Exercise to Reduce Frailty for Older Adult', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Implementing Resistance Exercise to Reduce Frailty for Older Adult Medicaid Waiver Recipients', 'orgStudyIdInfo': {'id': 'STU00201777'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual Care Group'}, {'type': 'OTHER', 'label': 'Intervention', 'description': 'Intervention Group', 'interventionNames': ['Behavioral: Resistance exercise']}], 'interventions': [{'name': 'Resistance exercise', 'type': 'BEHAVIORAL', 'description': 'resistance exercise', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor', 'investigatorFullName': 'Margaret Danilovich', 'investigatorAffiliation': 'Northwestern University'}}}}