PHysical Activity for Non-ambulatory Stroke Survivors: Feasibility Study

NCT ID: NCT03492957

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-09
• Study Completion Date: 2018-04-30

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Education on self-management, self-efficacy and lifestyle

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Edinburgh

OTHER

Sponsor Role: collaborator

Edinburgh Napier University

OTHER

Sponsor Role: collaborator

Glasgow Caledonian University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederike MJ van Wijck, PhD

Role: PRINCIPAL_INVESTIGATOR

Glasgow Caledonian University

Other Identifiers

SHLS1

Identifier Type: -

Identifier Source: org_study_id