Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-30 @ 10:40 PM
Study NCT ID:
NCT03492957
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2018-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PHysical Activity for Non-ambulatory Stroke Survivors: Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Blinding: outcomes are assessed by independent assessors, otherwise not involved in the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants can select either individual treatment at home, or group treatment in a community setting, but the intervention content and dose are the same.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-13', 'studyFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2018-04-09', 'lastUpdatePostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Canadian Occupational Performance Measure (COPM)', 'timeFrame': '3-month follow-up', 'description': 'Person-centred tool for goal setting and evaluation'}], 'secondaryOutcomes': [{'measure': 'Barthel Index (BI)', 'timeFrame': '3-month follow-up', 'description': 'Measure to evaluate independence in activities of daily living'}, {'measure': 'Stroke Impact Scale (SIS)', 'timeFrame': '3-month follow-up', 'description': 'Measure to evaluate impact of intervention on stroke-related impairments, activity limitations and participation restrictions'}, {'measure': 'Stroke Self-Efficacy questionnaire (SSEQ)', 'timeFrame': '3-month follow-up', 'description': 'Measure to evaluate level of confidence'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '3-month follow-up', 'description': 'Measure to evaluate levels of anxiety and depression'}, {'measure': 'Motricity Index (MI)', 'timeFrame': '3-month follow-up', 'description': 'Clinical evaluation of muscle strength in both affected and non-affected upper and lower limbs'}, {'measure': 'Force measurements', 'timeFrame': '3-month follow-up', 'description': 'Quantitative measurements of muscle force in quadriceps and hamstring muscles in both affected and unaffected lower limbs using dynamometry'}, {'measure': 'Caregiver Burden Scale (CBS)', 'timeFrame': '3-month follow-up', 'description': 'A questionnaire to evaluate carer burden'}, {'measure': 'Activity data', 'timeFrame': '3-month follow-up', 'description': 'Quantitative data from an activity monitor to measure sedentary behaviour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity', 'exercise', 'non-ambulatory', 'feasibility', 'mixed methods'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to design a physical activity programme for non-ambulatory stroke survivors (delivered via either community-based groups or a home-based individual programme) and evaluate its feasibility, acceptability, preliminary and adverse effects. The study will also explore the views of non-ambulatory stroke survivors and their carers on: needs, personal goals, barriers, and motivators, experiences of programme participated in and preferred format (i.e. home-based individual/ community-based groups).', 'detailedDescription': 'Background:\n\nPhysical activity interventions after stroke are needed because stroke survivors are under-active; their average physical fitness level is about 50% of sedentary healthy controls. This adversely affects vascular risk factor profiles, disability and participation, problems that are all likely to be exacerbated in stroke survivors who are unable to walk. Fitness can be improved after stroke through cardiorespiratory training. This also improves psychosocial functioning and adaptation to life after stroke. Community-based services for exercise after stroke are developing throughout the UK. However, current evidence, associated guidelines and exercise professional training mainly pertain to ambulatory stroke survivors; non-ambulatory stroke survivors have hardly been involved in this area of research. In this study, we define "non-ambulatory" as requiring at least "continuous or intermittent support of one person to help with balance or coordination" (i.e. Functional Ambulatory Category ≤ 2).\n\nStudy aim:\n\nThe aim of this study is to design a physical activity programme for non-ambulatory stroke survivors (delivered via either community-based groups or a home-based individual programme) and evaluate its feasibility, acceptability, preliminary and adverse effects. The study will also explore the views of non-ambulatory stroke survivors and their carers on: needs, personal goals, barriers, and motivators, experiences of programme participated in and preferred format (i.e. home-based individual/ community-based groups).\n\nStudy design:\n\nMixed-methods, observational feasibility study. This study will incorporate qualitative interviews/focus groups to explore the experiences of the programme participants are taking part in and their thoughts and views of PA after stroke. Interviews and focus groups will be conducted throughout the physical activity programme.\n\nParticipant recruitment:\n\nParticipants will be recruited by the Scottish Stroke Research Network (SRN) via: databases and electronic patient medical/nursing/AHP notes, records of discharges from acute stroke wards to off-site rehabilitation units and word of mouth among AHPs., within NHS Lanarkshire.\n\nParticipants will also be recruited via non-NHS sites: local community stroke groups, social media, stroke charities, press releases and related media and care homes.\n\nStudy setting:\n\nGlasgow Caledonian University will be used for the community-based group programme and focus groups/interviews.\n\nParticipants\' own home setting will be used for the home-based, individual programme and interviews.\n\nStudy participants:\n\nNon-ambulatory stroke survivors and their carers (where applicable) living at home or in care homes.\n\nStudy outcomes:\n\nOutcomes will include measures of disability, ADL, strength, anxiety and depression, sedentary behaviour, self-efficacy, health status, attainment of individual goals, as well as carer burden (where appropriate).\n\nFeasibility will be assessed by numbers of participants invited to participate, accepting and being recruited into the study, completing the intervention, programme adherence and drop outs. Safety data will be examined using data on adverse effects reported by participants.\n\nStudy duration: 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (stroke survivors):\n\n* Age 18 years or over\n* Clinical diagnosis of stroke\n* Non-ambulatory, defined as requiring at least "continuous or intermittent support of one person to help with balance or coordination" (i.e. Functional Ambulatory Category ≤ 2) most of the time.\n* Able to give informed consent (by proxy if appropriate)\n* Able to travel via private taxi to community venue (for group exercise, if preferred)\n* For care home residents: participant must not be participating in any structured form of PA run within their care home.\n* Participant residing in private home or care home (must be discharged from in-patient care at start of intervention)\n\nExclusion Criteria (stroke survivors):\n\n* Judged by treating GP to be too unwell to participate\n* Uncontrolled medical condition that contraindicates exercise e.g. uncontrolled cardiac condition\n* Severe cognitive impairment (unable to follow and understand instructions)\n\nInclusion criteria (carers):\n\n\\- Able to give informed consent\n\nExclusion criteria (carers):\n\n\\- Not well enough to participate (as per self-report)'}, 'identificationModule': {'nctId': 'NCT03492957', 'acronym': 'PHANSS', 'briefTitle': 'PHysical Activity for Non-ambulatory Stroke Survivors: Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Glasgow Caledonian University'}, 'officialTitle': 'PHysical Activity for Non-ambulatory Stroke Survivors (PHANSS-2): Developing a Feasible and Acceptable Intervention for Stroke Survivors Who Cannot Walk Independently', 'orgStudyIdInfo': {'id': 'SHLS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical activity', 'description': 'A tailored, person-centred, 12-week, chair-based exercise intervention to increase physical activity and fitness. Dose: one face-face session with a qualified physiotherapist plus two independent sessions per week. This is combined with education on self-management, self-efficacy and lifestyle change. There is no control group ion this feasibility study.', 'interventionNames': ['Other: Physical activity']}], 'interventions': [{'name': 'Physical activity', 'type': 'OTHER', 'otherNames': ['Education on self-management, self-efficacy and lifestyle'], 'description': 'A tailored, person-centred, 12-week, chair-based exercise intervention to increase physical activity and fitness. Dose: one face-face session with a qualified physiotherapist plus two independent sessions per week. This is combined with education on self-management, self-efficacy and lifestyle change.', 'armGroupLabels': ['Physical activity']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Frederike MJ van Wijck, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glasgow Caledonian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glasgow Caledonian University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Edinburgh', 'class': 'OTHER'}, {'name': 'Edinburgh Napier University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}