Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-30 @ 4:23 PM
Study NCT ID:
NCT04644861
Status:
COMPLETED
Last Update Posted:
2024-09-25
First Post:
2020-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adapted Physical Activity Centre (in The) CITY for Elders Aged 70 and Over with At Least One Long Term Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2020-11-24', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'feasibility of the adapted physical activity program (ratio 1)', 'timeFrame': 'Month 0', 'description': 'total number of patients included in the study'}, {'measure': 'feasibility of the adapted physical activity program (ratio 2)', 'timeFrame': 'Month 4', 'description': 'number of patients who complete the program of adapted physical activity in totality'}], 'secondaryOutcomes': [{'measure': 'feasibility complementary criteria Month 0', 'timeFrame': 'Month 0', 'description': 'number of patients who start the program of adapted physical activity'}, {'measure': 'feasibility complementary criteria Month 4', 'timeFrame': 'Month 4', 'description': 'reasons to not complete the program of adapted physical activity'}, {'measure': 'organization feasibility', 'timeFrame': 'Month 4', 'description': 'number of canceled sessions'}, {'measure': 'program adhesion (sessions realised)', 'timeFrame': 'Month 4', 'description': 'numbers of realised session'}, {'measure': "patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)", 'timeFrame': 'Month 0', 'description': "patient's quality of life measured by Whoqol-bref. Score from 0 to 100, higher score mean better outcome"}, {'measure': "patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)", 'timeFrame': 'Month 4', 'description': "patient's quality of life measured by Whoqol-bref. Score from 0 to 100, higher score mean better outcome"}, {'measure': "patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)", 'timeFrame': 'Month 12', 'description': "patient's quality of life measured by Whoqol-bref. Score from 0 to 100, higher score mean better outcome"}, {'measure': "patient's physical activity measured by GPAQ Global Physical Activity Questionnaire", 'timeFrame': 'Month 0', 'description': 'Global Physical Activity Questionnaire (GPAQ). Score from 0 to 3000. higher score mean better outcome'}, {'measure': "patient's physical activity measured by GPAQ Global Physical Activity Questionnaire", 'timeFrame': 'Month 6', 'description': 'Global Physical Activity Questionnaire (GPAQ), Score from 0 to 3000, higher score mean better outcome'}, {'measure': "patient's physical activity measured by GPAQ Global Physical Activity Questionnaire", 'timeFrame': 'Month 12', 'description': 'Global Physical Activity Questionnaire (GPAQ), Score from 0 to 3000, higher score mean better outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Disease', 'adapted physical activity', 'primary care', 'Motor Activity', 'Elders'], 'conditions': ['Chronic Disease']}, 'descriptionModule': {'briefSummary': 'Elders aged 70 and over, living in Toulouse, with a chronic disease identified by the French social insurance as an Affection Longue Durée will be eligible to a 4 months physical activity program in a primary health center. This program will be proposed by their general practitioner. The aim of the study is to establish the feasibility of such program conduced exclusively in primary care.', 'detailedDescription': 'The number of elders aged 70 and over and suffering of a chronic disease are increasing in our country. These patients are at risk of sarcopenia which can lead to an increasing risk of falls and hospitalization, loss of autonomy, and morbi-mortality. Twelve weeks adapted physical activity program can manage sarcopenia in elders. One of the difficulties to propose such a program to elders patients is the difficulty to reach the program center due to mobility deficiency. Our hypothesis is that proposing an adapted physical activity in a primary health care center, in the city of the patient, could help the participation.\n\nEligible patients addressed by their general practitioner will perform 4 months adapted physical activity program in the CAPA-CITY center (MSPU La Providence).\n\nThe inclusion will be realized by the sports doctor of CAPA-CITY. At M2, sport doctor and adapted physical activity teacher will meet the patient to readapt the program taking in count his particularity and wishes.\n\nAt M4 M6 and M12, an independent global evaluation will be realized by training nurse and clinical research associate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elders aged 70 and over, with a chronic disease recognize as an Long Term Affection by the French social insurance.\n* Living at home in Toulouse\n* With a general practitioner working in Toulouse and agreed to participate to the CAPA-CITY70 program research\n\nExclusion Criteria:\n\n* Elders living in nursing home\n* Elders dependent for daily activity (score \\< 5.5 Autonomy scale of Katz)\n* Elders with dementia according to DSM V criteria\n* Elders participating in another research project\n* Contraindication for physical activity'}, 'identificationModule': {'nctId': 'NCT04644861', 'acronym': 'CAPACITY70', 'briefTitle': 'Adapted Physical Activity Centre (in The) CITY for Elders Aged 70 and Over with At Least One Long Term Illness', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Evaluation of the Feasibility of a Physical Activity Program Adapted for Primary Care, for People Aged 70 and Over Who Have At Least One Long-term Illness', 'orgStudyIdInfo': {'id': 'RC31/19/0057'}, 'secondaryIdInfos': [{'id': '2020-A01164-35', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Elders aged 70', 'description': 'Program of adapted physical activity', 'interventionNames': ['Other: Program of adapted physical activity']}], 'interventions': [{'name': 'Program of adapted physical activity', 'type': 'OTHER', 'description': '3 workouts of one hour every week during 4 months. Program will be conducted by adapted physical activity teachers and sports doctor.', 'armGroupLabels': ['Elders aged 70']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de TOULOUSE', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Emile ESCOURROU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}