Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-23 @ 10:12 AM
Study NCT ID:
NCT01740505
Status:
COMPLETED
Last Update Posted:
2015-01-21
First Post:
2012-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HealthySteps: Exercise for Older Adults With Mobility Limitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051346', 'term': 'Mobility Limitation'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-19', 'studyFirstSubmitDate': '2012-11-23', 'studyFirstSubmitQcDate': '2012-11-29', 'lastUpdatePostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'energy cost of walking', 'timeFrame': '12 weeks', 'description': 'assessed by oxygen consumption during treadmill and overground walking'}, {'measure': 'fatigue and fatigability', 'timeFrame': '12 weeks', 'description': 'assessed by questionnaire, rated perceived exertion during walking, and decrements in walking performance over time.'}, {'measure': 'daily activity', 'timeFrame': '12 weeks', 'description': 'assessed by accelerometry and the Physical Activity Scale for the Elderly'}, {'measure': 'life-space mobility', 'timeFrame': '12 weeks', 'description': 'assessed by life-space mobility questionnaire'}, {'measure': 'endurance', 'timeFrame': '12 weeks', 'description': 'assessed by the long-distance corridor walk'}, {'measure': 'physical function', 'timeFrame': '12 weeks', 'description': 'assessed by standing balance, gait speed, and chair stands'}], 'secondaryOutcomes': [{'measure': 'energy cost of walking', 'timeFrame': '24 weeks', 'description': 'assessed by oxygen consumption during treadmill and overground walking'}, {'measure': 'fatigue and fatigability', 'timeFrame': '24 weeks', 'description': 'assessed by questionnaire, rated perceived exertion during walking, and decrements in walking performance over time'}, {'measure': 'daily activity', 'timeFrame': '24 weeks', 'description': 'assessed by accelerometry and the Physical Activity Scale for the Elderly'}, {'measure': 'life-space mobility', 'timeFrame': '24 weeks', 'description': 'assessed by the life-space mobility questionnaire'}, {'measure': 'endurance', 'timeFrame': '24 weeks', 'description': 'assessed by the long-distance corridor walk'}, {'measure': 'physical function', 'timeFrame': '24 weeks', 'description': 'assessed by standing balance, gait speed, and chair stands'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['energy cost of walking', 'energy metabolism', 'aged', 'older adult', 'exercise', 'gait', 'walking', 'aerobic', 'motor skill'], 'conditions': ['Mobility Limitation']}, 'descriptionModule': {'briefSummary': 'This study will compare three different exercise programs in older adults who report difficulty walking and will determine if the programs improve walking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women who live in the lower mainland (greater Vancouver) area of British Columbia\n* Aged 65 years or older\n* Living independently in their own home\n* Report mobility limitation, defined as any difficulty walking one-quarter mile (about 2-3 blocks) outside on level ground or climbing one flight of stairs (about 10 steps) without resting because of a health or physical problem\n\nExclusion Criteria:\n\n* Have a current medical condition for which exercise is contraindicated\n* Have participated in an exercise intervention study in the past 6 months\n* Do not have adequate cognitive function to provide informed consent and participate fully in the study\n* Do not speak and understand English fluently'}, 'identificationModule': {'nctId': 'NCT01740505', 'acronym': 'HealthySteps', 'briefTitle': 'HealthySteps: Exercise for Older Adults With Mobility Limitation', 'organization': {'class': 'OTHER', 'fullName': 'Simon Fraser University'}, 'officialTitle': 'HealthySteps: A Pilot Randomized Controlled Trial of Exercise to Improve Walking Energetics, Fatigue, and Activity in Older Adults With Mobility Limitation', 'orgStudyIdInfo': {'id': 'DFMG-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Timing and Coordination', 'interventionNames': ['Behavioral: Timing and Coordination']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic Walking', 'interventionNames': ['Behavioral: Aerobic Walking']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stretching and Relaxation', 'interventionNames': ['Behavioral: Stretching and Relaxation']}], 'interventions': [{'name': 'Timing and Coordination', 'type': 'BEHAVIORAL', 'description': 'This intervention is based on progressively difficult stepping and walking patterns that promote the timing and coordination of stepping within the gait cycle. Small-group 60-minute classes twice weekly for 12 weeks.', 'armGroupLabels': ['Timing and Coordination']}, {'name': 'Aerobic Walking', 'type': 'BEHAVIORAL', 'description': 'Outdoor walking with progressive increases in exercise intensity. Small-group 60-minute classes twice weekly for 12 weeks.', 'armGroupLabels': ['Aerobic Walking']}, {'name': 'Stretching and Relaxation', 'type': 'BEHAVIORAL', 'description': 'Full-body stretching, range-of-motion exercises, and relaxation techniques. No specific gait training. Small-group 60-minute classes twice weekly for 12 weeks.', 'armGroupLabels': ['Stretching and Relaxation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Dawn C Mackey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Simon Fraser University; Vancouver Coastal Health Research Institute, Centre for Hip Health and Mobility'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Simon Fraser University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Drummond Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dawn C. Mackey', 'investigatorAffiliation': 'Simon Fraser University'}}}}