ClinicalTrials.gg
CompletedNCT03492957PHANSSUpdated Aug 16, 2021

PHysical Activity for Non-ambulatory Stroke Survivors: Feasibility Study

An interventional study of Physical activity in Stroke, sponsored by Glasgow Caledonian University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-16.

Sponsored by Glasgow Caledonian University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2017, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Stroke by Glasgow Caledonian University — 2 open to participants now, 2 under way, none of them phase 3. Stroke · Glasgow Caledonian University.

Enrollment
9th of 10
9 · median 49
Started
2017
with 1 other
No phase
9 of 11
2 open now
Registered
5th of 11
by date

Among the 11 studies in Stroke by Glasgow Caledonian University, this one is the 9th largest by enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2017, is one of 9 with no phase, and was the 5th registered.

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

Browse Stroke studies →

Open to participants now

2 of the 11 studies in Stroke by Glasgow Caledonian University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Stroke by Glasgow Caledonian University, or all of them as a file.
02

Study 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).

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.

03

Conditions studied

  • Stroke

Keywords

  • physical activity
  • exercise
  • non-ambulatory
  • feasibility
  • mixed methods
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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 (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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Physical activity

    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.

    Other: Physical activity

Interventions

  • OtherPhysical activity

    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.

    Also known as: Education on self-management, self-efficacy and lifestyle

06

What researchers measure

Primary outcomes

  1. Canadian Occupational Performance Measure (COPM)

    Person-centred tool for goal setting and evaluation

    Time frame: 3-month follow-up

Secondary outcomes

  1. Barthel Index (BI)

    Measure to evaluate independence in activities of daily living

    Time frame: 3-month follow-up

  2. Stroke Impact Scale (SIS)

    Measure to evaluate impact of intervention on stroke-related impairments, activity limitations and participation restrictions

    Time frame: 3-month follow-up

  3. Stroke Self-Efficacy questionnaire (SSEQ)

    Measure to evaluate level of confidence

    Time frame: 3-month follow-up

  4. Hospital Anxiety and Depression Scale (HADS)

    Measure to evaluate levels of anxiety and depression

    Time frame: 3-month follow-up

  5. Motricity Index (MI)

    Clinical evaluation of muscle strength in both affected and non-affected upper and lower limbs

    Time frame: 3-month follow-up

  6. Force measurements

    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

  7. Caregiver Burden Scale (CBS)

    A questionnaire to evaluate carer burden

    Time frame: 3-month follow-up

  8. Activity data

    Quantitative data from an activity monitor to measure sedentary behaviour

    Time frame: 3-month follow-up

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Jan 2018, 12 months.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 12 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2018
First posted
Apr 10, 2018
StartActual
Jan 9, 2017
Primary completionActual
Jan 16, 2018
CompletionActual
Apr 30, 2018
Last update
Aug 16, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03492957
Lead sponsor
Glasgow Caledonian University
Collaborators
University of Edinburgh, Edinburgh Napier University
Responsible party
Sponsor
First posted
Apr 10, 2018
Start date
Jan 9, 2017
Primary completion
Jan 16, 2018
Completion
Apr 30, 2018
Last update
Aug 16, 2021

Study contacts

Frederike MJ van Wijck, PhD
principal investigator · Glasgow Caledonian University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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