PHysical Activity for Non-ambulatory Stroke Survivors: Feasibility Study (PHANSS)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring physical activity, exercise, non-ambulatory, feasibility, mixed methods
Eligibility Criteria
Inclusion Criteria (stroke survivors):
- Age 18 years or over
- Clinical diagnosis of stroke
- 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.
- Able to give informed consent (by proxy if appropriate)
- Able to travel via private taxi to community venue (for group exercise, if preferred)
- For care home residents: participant must not be participating in any structured form of PA run within their care home.
- Participant residing in private home or care home (must be discharged from in-patient care at start of intervention)
Exclusion Criteria (stroke survivors):
- Judged by treating GP to be too unwell to participate
- Uncontrolled medical condition that contraindicates exercise e.g. uncontrolled cardiac condition
- Severe cognitive impairment (unable to follow and understand instructions)
Inclusion criteria (carers):
- Able to give informed consent
Exclusion criteria (carers):
- Not well enough to participate (as per self-report)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physical activity
Arm 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.
Outcomes
Primary Outcome Measures
Canadian Occupational Performance Measure (COPM)
Person-centred tool for goal setting and evaluation
Secondary Outcome Measures
Barthel Index (BI)
Measure to evaluate independence in activities of daily living
Stroke Impact Scale (SIS)
Measure to evaluate impact of intervention on stroke-related impairments, activity limitations and participation restrictions
Stroke Self-Efficacy questionnaire (SSEQ)
Measure to evaluate level of confidence
Hospital Anxiety and Depression Scale (HADS)
Measure to evaluate levels of anxiety and depression
Motricity Index (MI)
Clinical evaluation of muscle strength in both affected and non-affected upper and lower limbs
Force measurements
Quantitative measurements of muscle force in quadriceps and hamstring muscles in both affected and unaffected lower limbs using dynamometry
Caregiver Burden Scale (CBS)
A questionnaire to evaluate carer burden
Activity data
Quantitative data from an activity monitor to measure sedentary behaviour
Full Information
NCT ID
NCT03492957
First Posted
March 27, 2018
Last Updated
August 13, 2021
Sponsor
Glasgow Caledonian University
Collaborators
University of Edinburgh, Edinburgh Napier University
1. Study Identification
Unique Protocol Identification Number
NCT03492957
Brief Title
PHysical Activity for Non-ambulatory Stroke Survivors: Feasibility Study
Acronym
PHANSS
Official Title
PHysical Activity for Non-ambulatory Stroke Survivors (PHANSS-2): Developing a Feasible and Acceptable Intervention for Stroke Survivors Who Cannot Walk Independently
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 9, 2017 (Actual)
Primary Completion Date
January 16, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glasgow Caledonian University
Collaborators
University of Edinburgh, Edinburgh Napier University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
Background:
Physical 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).
Study aim:
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).
Study design:
Mixed-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.
Participant recruitment:
Participants 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.
Participants will also be recruited via non-NHS sites: local community stroke groups, social media, stroke charities, press releases and related media and care homes.
Study setting:
Glasgow Caledonian University will be used for the community-based group programme and focus groups/interviews.
Participants' own home setting will be used for the home-based, individual programme and interviews.
Study participants:
Non-ambulatory stroke survivors and their carers (where applicable) living at home or in care homes.
Study outcomes:
Outcomes 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).
Feasibility 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.
Study duration: 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
physical activity, exercise, non-ambulatory, feasibility, mixed methods
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants can select either individual treatment at home, or group treatment in a community setting, but the intervention content and dose are the same.
Masking
None (Open Label)
Masking Description
Blinding: outcomes are assessed by independent assessors, otherwise not involved in the study.
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical activity
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Physical activity
Other Intervention Name(s)
Education on self-management, self-efficacy and lifestyle
Intervention 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.
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Description
Person-centred tool for goal setting and evaluation
Time Frame
3-month follow-up
Secondary Outcome Measure Information:
Title
Barthel Index (BI)
Description
Measure to evaluate independence in activities of daily living
Time Frame
3-month follow-up
Title
Stroke Impact Scale (SIS)
Description
Measure to evaluate impact of intervention on stroke-related impairments, activity limitations and participation restrictions
Time Frame
3-month follow-up
Title
Stroke Self-Efficacy questionnaire (SSEQ)
Description
Measure to evaluate level of confidence
Time Frame
3-month follow-up
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Measure to evaluate levels of anxiety and depression
Time Frame
3-month follow-up
Title
Motricity Index (MI)
Description
Clinical evaluation of muscle strength in both affected and non-affected upper and lower limbs
Time Frame
3-month follow-up
Title
Force measurements
Description
Quantitative measurements of muscle force in quadriceps and hamstring muscles in both affected and unaffected lower limbs using dynamometry
Time Frame
3-month follow-up
Title
Caregiver Burden Scale (CBS)
Description
A questionnaire to evaluate carer burden
Time Frame
3-month follow-up
Title
Activity data
Description
Quantitative data from an activity monitor to measure sedentary behaviour
Time Frame
3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (stroke survivors):
Age 18 years or over
Clinical diagnosis of stroke
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.
Able to give informed consent (by proxy if appropriate)
Able to travel via private taxi to community venue (for group exercise, if preferred)
For care home residents: participant must not be participating in any structured form of PA run within their care home.
Participant residing in private home or care home (must be discharged from in-patient care at start of intervention)
Exclusion Criteria (stroke survivors):
Judged by treating GP to be too unwell to participate
Uncontrolled medical condition that contraindicates exercise e.g. uncontrolled cardiac condition
Severe cognitive impairment (unable to follow and understand instructions)
Inclusion criteria (carers):
- Able to give informed consent
Exclusion criteria (carers):
- Not well enough to participate (as per self-report)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederike MJ van Wijck, PhD
Organizational Affiliation
Glasgow Caledonian University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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PHysical Activity for Non-ambulatory Stroke Survivors: Feasibility Study
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