Physical Activity Maintenance Intervention for People With Stroke (PREP Maintain)

April 28, 2026 updated by: Katy Pedlow, University of Ulster

Co-design of a Physical Activity Maintenance Intervention for People With Stroke

Most people living with stroke engage in low levels of physical activity putting them at higher risk of having a second stroke and developing a range of chronic health conditions. Despite their desire to participate in physical activity, numerous barriers exist. Whilst Northern Ireland Chest Heart and Stroke has successfully implemented the Post Rehabilitation Exercise Programme, the challenge arises post-completion, as survivors of stroke struggle to sustain physical activity over the longer term. This study aims to design and test an intervention to support physical activity in the longer term.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The main objective of this study is to understand the perspectives of key stakeholders on the components, structure, and content of a physical activity maintenance intervention, ensuring the intervention is relevant, acceptable, and feasible for all stakeholders. The second objective is to co-design and refine a prototype intervention using an iterative process, actively involving stakeholders in the development and customisation of the intervention to meet their specific needs and preferences. This mixed methods study involving three stages of the DECIPHer co-production include; 1) evidence review/stakeholder consultation, 2) co-production, and 3) prototyping. Stage 1 will consist of multiple focus groups of Post Rehabilitation Exercise Programme (PREP) participants, staff, and health care professionals. Stage 2 aims to co-design the content, structure, and materials of the PREP maintenance programme, building on stage 1 data. At least 10 participants; 2 from each stakeholder group i.e. healthcare workers, PREP staff, and PREP participants, who completed stage 1 will be asked to take part in the second stage. The workshops will aim to discuss intervention content, sturcture, and materials. Stage 3 will be the prototype stage where what is developed in stage 2 is brought forward to the post-PREP groups.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom
        • Ulster University
      • Belfast, United Kingdom, BT15 1ED
        • Ulster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PREP Participants:

    1. Adults 18 years and older with a clinical diagnosis of stroke, currently attending PREP or completed PREP. Adults with communication impairment will be able to participate via alternative methods of communication (e.g., assistive communication device).
    2. Carers who have supported an adult who have a clinical diagnosis of stroke to complete PREP either currently or have completed PREP.

  • PREP Staff/Health Care workers:

    1. Currently working for Northern Ireland Chest Heart and Stroke as a care coordinator role or PREP delivery physiotherapist
    2. Minimum experience of 12 weeks involvement in PREP. Or
    3. Have experience of supporting people with stroke to complete physical activity within the community setting e.g exercise, health, voluntary and statutory organization staff. (There is no minimum amount of experience required (i.e. even if they have supported one person, they can still participate) and therefore there is no additional criteria required for these subjects.)

Exclusion Criteria:

  • PREP Participants:

    1. Unable to participate in a group based conversation.
    2. Carers who have no knowledge or experience of PREP.
    3. Unable to use/access a digital device with internet access and a microphone (for online focus group only).
    4. Being a member of the advisory board

  • PREP Staff/Health care workers:

    1. Experience of supporting people with stroke to complete physical activity within the acute hospital setting only.
    2. Unable to use/access a digital device with internet access and a microphone (for online focus group only).
    3. Being a member of the advisory board

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort
A group of stakeholders (people living with stroke, carers, therapists and health and fitness professionals) will co-design a physical activity maintenance program. This will then be trialled with a cohort of stroke survivors.
Other: Physical activity maintenance
Co-designed PA maintenance program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Physical Activity Questionnaire short form
Time Frame: Baseline (pre intervention), post intervention (week 6) and 3 months post intervention completion
Self report questionnaire measuring physical activity levels related to low, moderate and high intensity activity and amount of time sitting
Baseline (pre intervention), post intervention (week 6) and 3 months post intervention completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulster

Collaborators

Northern Ireland Chest Heart and Stroke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

July 4, 2026

Study Completion (Estimated)

August 28, 2026

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/24/0044
  • FCNUR-24-062 (Other Identifier: Ulster University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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