Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-25 @ 3:22 PM
Study NCT ID:
NCT01748461
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
2012-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Objective Assessment and Promotion of Physical Activity in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '2012-12-03', 'studyFirstSubmitQcDate': '2012-12-11', 'lastUpdatePostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in objective and subjective measures of degree of physical activity', 'timeFrame': 'baseline, 10 weeks, 6 months, 1 year', 'description': 'Physical activity will be measured using a standardized questionnaire and a Sensewear. A Sensewear is an activity monitor (accelerometer) carried on the upper arm during several days and registers the amount of physical activity.'}, {'measure': 'Change in objective measures of physical fitness', 'timeFrame': 'baseline, 10 weeks, 6 months, 1 year', 'description': 'Physical fitness will be measured using a standardized Six-Minute Walk Test and a Six-Minute Cycle Test.'}, {'measure': 'Change in objective measures of functionality', 'timeFrame': 'baseline, 10 weeks, 6 months, 1 year', 'description': 'Functionality will be measured using the standardized The Physical Performance Test and 2 strength tests (hand grip and knee extension).'}], 'secondaryOutcomes': [{'measure': 'Change in mental well-being', 'timeFrame': 'baseline, 10 weeks, 6 months, 1 year', 'description': 'Standardized questionnaire'}, {'measure': 'Change in motivation to be physically active', 'timeFrame': 'baseline, 10 weeks, 6 months, 1 year', 'description': 'Standardized questionnaire'}, {'measure': 'Change in self-efficacy to be physically active', 'timeFrame': 'baseline, 10 weeks, 6 months, 1 year', 'description': 'Standardized questionnaire'}]}, 'conditionsModule': {'keywords': ['intervention study in elderly (65+)', 'cycle ergometer', 'physical activity', 'physical fitness', 'assisted living facility'], 'conditions': ['Elderly']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to evaluate the short-term and long-term effects of a cycle ergometer program on physical activity and physical fitness in elderly (65+). Therefore, physical activity, physical fitness and functionality are measured at baseline, after 10 weeks (after the intervention period), after 6 months and after 1 year.\n\nDifferent coaching techniques (to promote the use of a cycle ergometer and cycle ergometer program) will also be evaluated. What is the best (coaching) approach for long-term adherence (physical activity)?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 yrs\n* residents of a service flat\n* No frequent use of bike / cycle ergometer\n\nExclusion Criteria:\n\n* recent cardiovascular event or fracture\n* vestibular or thrombotic disorder\n* severe dementia\n* need for oxygen supplementation during daily activities'}, 'identificationModule': {'nctId': 'NCT01748461', 'briefTitle': 'Objective Assessment and Promotion of Physical Activity in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'orgStudyIdInfo': {'id': 'ML8733'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Structured intervention', 'description': 'Supervised cycle ergometer program', 'interventionNames': ['Behavioral: Structured intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Coach intervention', 'description': 'Non-supervised cycle ergometer program', 'interventionNames': ['Behavioral: Coach intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No cycle ergometer program'}], 'interventions': [{'name': 'Structured intervention', 'type': 'BEHAVIORAL', 'description': '3x/week - 10 weeks - Support by fitness instructor - Individualised exercise program (cycle ergometer)', 'armGroupLabels': ['Structured intervention']}, {'name': 'Coach intervention', 'type': 'BEHAVIORAL', 'description': 'promote autonomy - 4 visits during 10 weeks - Support by coach (encouragement) - Individualised exercise program', 'armGroupLabels': ['Coach intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3001', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Faculty of Kinesiology and Rehabilitation Sciences', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}