Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-01 @ 10:33 AM
Study NCT ID:
NCT05287932
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2022-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Physical Activity Intervention for Older People With Multimorbidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071069', 'term': 'Multiple Chronic Conditions'}, {'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors will be blinded to group allocation, and participants will be asked to not disclose their allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2022-03-10', 'studyFirstSubmitQcDate': '2022-03-10', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average daily acceleration', 'timeFrame': '4 weeks', 'description': 'Average acceleration from wrist accelerometry'}], 'secondaryOutcomes': [{'measure': 'Intensity gradient', 'timeFrame': '4 weeks', 'description': 'Intensity gradient from wrist accelerometry'}, {'measure': 'Time in MVPA', 'timeFrame': '4 weeks', 'description': 'Average daily time spent in moderate-to-vigorous physical activity from wrist accelerometry'}, {'measure': 'Steps', 'timeFrame': '4 weeks', 'description': 'Average daily step count'}, {'measure': 'Muscle strengthening exercise', 'timeFrame': '4 weeks', 'description': 'Average daily time spent doing muscle strengthening exercise'}, {'measure': '30-second chair rise performance', 'timeFrame': '4 weeks', 'description': 'Number of sit-to-stand movements completed within 30 seconds'}, {'measure': 'Handgrip strength', 'timeFrame': '4 weeks', 'description': 'Maximum handgrip strength measured on both hands using a Jamar handgrip dynamometer'}, {'measure': 'Timed 8ft up and go performance', 'timeFrame': '4 weeks', 'description': 'Time to complete 8ft up and go test'}, {'measure': 'Timed single-leg balance performance', 'timeFrame': '4 weeks', 'description': 'Time able to stand on one limb'}, {'measure': '6-minute walk test performance', 'timeFrame': '4 weeks', 'description': 'Total distance walked during 6-minute corridor walking test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multimorbidity', 'Older people', 'Physical activity'], 'conditions': ['Chronic Conditions, Multiple', 'Old Age; Debility', 'Physical Inactivity']}, 'descriptionModule': {'briefSummary': "Physical activity is an important determinant of health and well-being in older people. However, many older people do not achieve recommended physical activity levels and increasing older people's physical activity is challenging. This preliminary study will explore the effects of a brief physical activity intervention on physical activity and physical function in older people with multimorbidity. The findings will be used to inform the design of a subsequent adequately-powered randomised controlled trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged ≥60 years\n* 2 or more chronic conditions\n* able to walk outside the home\n* able to attend the study visits\n\nExclusion Criteria:\n\n* living in a residential or nursing home\n* housebound\n* ≥3 falls in previous year\n* dementia or significant cognitive impairment (unable to follow simple instructions)\n* contraindication to increasing physical activity\n* unable to read or speak English\n* unable to provide consent\n* no more than one person per household'}, 'identificationModule': {'nctId': 'NCT05287932', 'briefTitle': 'Brief Physical Activity Intervention for Older People With Multimorbidity', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'A Pilot Randomised Controlled Trial of a Brief Physical Activity Intervention in Older People With Multimorbidity', 'orgStudyIdInfo': {'id': 'HLSGT030322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Brief physical activity intervention including an initial 45-minute physical activity consultation, telephone support after 2 weeks (approx. 15-minute call), and provision of a pedometer, written information, and a physical activity diary. Embedded behaviour change techniques will include goal setting, self-monitoring, building self-efficacy and social support, and overcoming barriers.', 'interventionNames': ['Behavioral: Brief physical activity intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control', 'description': 'The control group will not receive any active or placebo intervention during the 4-week study period. They will also not receive any trial contacts during this period. They will however continue to be able to access their usual care from primary, secondary, community, and social services. After the final (4-week) follow-up assessment, this group will receive the full physical activity intervention.'}], 'interventions': [{'name': 'Brief physical activity intervention', 'type': 'BEHAVIORAL', 'description': 'See arm/group descriptions', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Northumbria University', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}], 'overallOfficials': [{'name': 'Garry A Tew, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northumbria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'External requests for this data will be considered by the Chief Investigator after the publication of the main trial findings.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Garry Tew', 'investigatorFullName': 'Garry Tew', 'investigatorAffiliation': 'Northumbria University'}}}}