Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT01503203
Status:
UNKNOWN
Last Update Posted:
2012-01-02
First Post:
2011-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Virtual Training for Older Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, 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': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-29', 'studyFirstSubmitDate': '2011-12-16', 'studyFirstSubmitQcDate': '2011-12-29', 'lastUpdatePostDateStruct': {'date': '2012-01-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'up to 8 weeks', 'description': 'The low back pain will be assessed with numeric pain scale two times (pre and post-intervention).'}], 'secondaryOutcomes': [{'measure': 'Body Balance', 'timeFrame': 'up to 8 weeks', 'description': 'The body balance will be assessed with Wii Balance Board two times (pre and post-intervention).'}, {'measure': 'Functional autonomy', 'timeFrame': 'up to 8 weeks', 'description': 'The functional autonomy will be assessed with sit-to-stand test pre and post-intervention.'}, {'measure': 'Mood', 'timeFrame': 'up to 8 weeks', 'description': 'The mood will be assessed with Profile of Mood State (POMS) two times (pre and post-intervention)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Older', 'virtual systems', 'low back pain', 'postural balance'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be assess the effectiveness of the physical virtual training on nonspecific chronic low back pain, body balance, functional autonomy and mood of older women. Two groups will be formed. One will do strength exercises and core training. The other group will do the same exercises more virtual activities with Nintendo Wii. Will be measure pre and post-intervention of the responses already shown above.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects with nonspecific chronic low back pain\n* patients without involvement in regular exercise program\n\nExclusion Criteria:\n\n* patients not recommended for physical exercise (Physical Activity Readiness Questionnaire PAR-Q)\n* trunk surgery\n* cancer\n* injuries in lower extremity\n* neurological or vestibular disease'}, 'identificationModule': {'nctId': 'NCT01503203', 'briefTitle': 'Physical Virtual Training for Older Women', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Gama Filho'}, 'officialTitle': 'Physical Virtual Training Effectiveness on Nonspecific Chronic Low Back Pain, Body Balance, Functional Autonomy and Mood of Older Women', 'orgStudyIdInfo': {'id': 'RSMJ20112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wii Group', 'description': 'This group will do the same training of the Prime Group. However will do also Physical Virtual Training using Nintendo Wii and Wii Balance Board. The physical virtual training going to applied during thirty minutes.', 'interventionNames': ['Other: Physical Virtual Training', 'Other: Strength Training', 'Other: Core Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prime Group', 'description': 'This group will do strength exercises and core training.', 'interventionNames': ['Other: Strength Training', 'Other: Core training']}], 'interventions': [{'name': 'Strength Training', 'type': 'OTHER', 'otherNames': ['Resistance training'], 'description': 'It will be does three times per week. The exercises are: squat, single leg squat, leg extension, leg curl, chair adductor, chair abductor and double plantar flexion.', 'armGroupLabels': ['Prime Group']}, {'name': 'Core training', 'type': 'OTHER', 'description': 'Exercises for trunk stabilization. Will be lateral, front and back bridges. It will be does three times per week with three sets between fifteen and third seconds.', 'armGroupLabels': ['Prime Group']}, {'name': 'Physical Virtual Training', 'type': 'OTHER', 'description': 'The video game (Nintendo Wii and Wii Balance Board) will used for intervention. After strength and core training will be applied the physical virtual training during thirty minutes. Tho total time session for the Wii Group will be 110 minutes.', 'armGroupLabels': ['Wii Group']}, {'name': 'Strength Training', 'type': 'OTHER', 'otherNames': ['Resistance training'], 'description': 'It will be does three times per week. The exercises are: squat, single leg squat, leg extension, leg curl, chair adductor, chair abductor and double plantar flexion.', 'armGroupLabels': ['Wii Group']}, {'name': 'Core Training', 'type': 'OTHER', 'description': 'Exercises for trunk stabilization. Will be lateral, front and back bridges. It will be does three times per week with three sets between fifteen and third seconds.', 'armGroupLabels': ['Wii Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '555', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Renato S Monteiro Junior, Professor', 'role': 'CONTACT', 'email': 'renatoprofedfis@hotmail.com', 'phone': '552192447872'}, {'name': 'Renato S Monteiro Junior, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fisioprime Clinical of Physiotherapy', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'centralContacts': [{'name': 'Elirez B da Silva, Doctor', 'role': 'CONTACT', 'email': 'elirezsilva@ugf.br', 'phone': '552125997183'}, {'name': 'Renato S Monteiro Junior, Professor', 'role': 'CONTACT', 'email': 'renatoprofedfis@hotmail.com', 'phone': '552192447872'}], 'overallOfficials': [{'name': 'Elirez B da Silva, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gama Filho University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Gama Filho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Renato Sobral Monteiro Junior', 'investigatorAffiliation': 'Universidade Gama Filho'}}}}