StrokePHANSSNCT03492957
PHysical Activity for Non-ambulatory Stroke Survivors: Feasibility Study
A study testing Physical activity in people with Stroke, run by Glasgow Caledonian University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
- Able to give informed consent
Who cannot join
- 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)
- Not well enough to participate (as per self-report)
About this study
Official title: PHysical Activity for Non-ambulatory Stroke Survivors (PHANSS-2): Developing a Feasible and Acceptable Intervention for Stroke Survivors Who Cannot Walk Independently
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).
Read the 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.
- Conditions
- Stroke
- Being tested
- Physical activity
- Keywords
- physical activity, exercise, non-ambulatory, feasibility, mixed methods
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Also called Education on self-management, self-efficacy and lifestyle
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | 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. Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM)
Person-centred tool for goal setting and evaluation
Measured: 3-month follow-up
Secondary outcomes (8)
Barthel Index (BI)
Measure to evaluate independence in activities of daily living
Measured: 3-month follow-up
Stroke Impact Scale (SIS)
Measure to evaluate impact of intervention on stroke-related impairments, activity limitations and participation restrictions
Measured: 3-month follow-up
Stroke Self-Efficacy questionnaire (SSEQ)
Measure to evaluate level of confidence
Measured: 3-month follow-up
Hospital Anxiety and Depression Scale (HADS)
Measure to evaluate levels of anxiety and depression
Measured: 3-month follow-up
Motricity Index (MI)
Clinical evaluation of muscle strength in both affected and non-affected upper and lower limbs
Measured: 3-month follow-up
Force measurements
Quantitative measurements of muscle force in quadriceps and hamstring muscles in both affected and unaffected lower limbs using dynamometry
Measured: 3-month follow-up
Caregiver Burden Scale (CBS)
A questionnaire to evaluate carer burden
Measured: 3-month follow-up
Activity data
Quantitative data from an activity monitor to measure sedentary behaviour
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start9 Jan 2017
- Primary completion16 Jan 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, Edinburgh Napier University
- Responsible party
- Sponsor
- Investigators
- Frederike MJ van Wijck, PhD, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492957
- Sponsor's protocol ID
- SHLS1
- Acronym
- PHANSS
- Status last verified
- Aug 2021
- First submitted
- 27 Mar 2018
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHysical Activity for Non-ambulatory Stroke Survivors (PHANSS-2): Developing a Feasible and Acceptable Intervention for Stroke Survivors Who Cannot Walk Independently
- ClinicalTrials.gov ID
- NCT03492957
- Acronym / sponsor ID
- PHANSS / SHLS1
- Conditions
- Stroke
- Keywords
- physical activity, exercise, non-ambulatory, feasibility, mixed methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- University of Edinburgh, Edinburgh Napier University
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Other: Physical activityA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
- Not well enough to participate (as per self-report)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityAlso: Education on self-management, self-efficacy and lifestyleA 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. | Other | Physical activity |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: 3-month follow-up
Person-centred tool for goal setting and evaluation
8 secondary outcomes
Barthel Index (BI)
Time frame: 3-month follow-up
Stroke Impact Scale (SIS)
Time frame: 3-month follow-up
Stroke Self-Efficacy questionnaire (SSEQ)
Time frame: 3-month follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: 3-month follow-up
Motricity Index (MI)
Time frame: 3-month follow-up
Force measurements
Time frame: 3-month follow-up
Caregiver Burden Scale (CBS)
Time frame: 3-month follow-up
Activity data
Time frame: 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
RecruitingPhase 3
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
Atrial Fibrillation
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
Recruiting
Electroacupuncture and rTMS for Post-Stroke Motor Recovery
Stroke
Active, not recruiting
Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation
Ischemic Stroke, Atrial Fibrillation
Recruiting
Functional Improvement in Subacute/Chronic Stroke Through Non-invasive Virtual-reality-Based Telerehabilitation
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederike MJ van Wijck, PhD principal investigator
Glasgow Caledonian University
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Stroke, run by Glasgow Caledonian University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021; AzTrials last refreshed its copy on 4 Nov 2026.