Clinical trial NCT03492957: PHysical Activity for Non-ambulatory Stroke Survivors: Feasibility 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: physical activity
exercise
non-ambulatory
feasibility
mixed methods
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
name: Edinburgh Napier University
First posted: 2018-04-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Barthel Index (BI)
timeFrame: 3-month follow-up
measure: Stroke Impact Scale (SIS)
timeFrame: 3-month follow-up
measure: Stroke Self-Efficacy questionnaire (SSEQ)
timeFrame: 3-month follow-up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3-month follow-up
measure: Motricity Index (MI)
timeFrame: 3-month follow-up
measure: Force measurements
timeFrame: 3-month follow-up
measure: Caregiver Burden Scale (CBS)
timeFrame: 3-month follow-up
measure: Activity data
timeFrame: 3-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Glasgow Caledonian University
name: Frederike MJ van Wijck, PhD
role: PRINCIPAL_INVESTIGATOR
References: