Effect of a Community Exercise Programme on Stroke Patients

NCT05320549 | Recruiting DMC

• 1 other identifier: Faulkner_HELP Hampshire-2022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Physical activity is known to be beneficial for supporting health and wellbeing. A number of schemes and strategies have been developed to improve uptake of physical activity in the United Kingdom (UK) population, including the 'Everybody active, every day' framework. This framework includes recommendations for referral from a healthcare professional for people to become more active. For those with an existing health condition or other risk factors that could lead to health problems, such referrals may be to an 'exercise referral scheme' (ERS). However, there are often limited opportunities for individuals diagnosed with stroke and/or a Transient Ischaemic Attack (TIA to engage in rigorously monitored, exercise and behaviour change opportunities once they have been discharged from the National Health Service (NHS). In Winchester, General Practitioners (GPs) refer approximately 10 to 20 stroke/TIA patients to the Winchester City Council led exercise referral scheme each year, despite the local trust (Hampshire Hospitals NHS Foundation Trust; HHFT) diagnosing approx. 1000 cases each year. With limited time and resources for GPs to effectively refer eligible patients to the programme, greater engagement with NHS hospitals may be necessary to increase the referral and uptake of such programmes. Accordingly, the Health Enhancing Lifestyle Programme (HELP) Hampshire Stroke Clinic (www.helphampshire.co.uk) was launched in March 2019 and provides individuals who have experienced a stroke with various community-based, accessible, group-focused exercise opportunities. Referrals primarily come from consultants, physiotherapists and occupational therapists from HHFT. The purpose of this study is to document outcomes (physical, psycho-social, economic) to indicate the effectiveness of the HELP Hampshire exercise referral scheme.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Quality of Life - EuroQuol 5 Dimensions 5 levels (EQ-5D-5L)

  5-item questionnaire that assesses quality of life. Higher scores mean better quality of life. Minimum score is 1 and the maximum score is 5 for each dimension

  Change from baseline to up to 12 weeks and 36 weeks after baseline

• General Health Questionnaire -Short-Form-12 (SF12)

  12-item questionnaire that assesses quality of life. Higher scores mean better general health. Scores range from 0 to 100.

  Change from baseline to up to 12 weeks and 36 weeks after baseline

Secondary Outcomes (10)

• International Physical Activity Questionnaire Short-Form

  Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline

• Weight

  Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline

• Height

  Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline

• Body Mass Index

  Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline

• Stages of Change for Exercise Participation

  Baseline, up to 12 weeks after baseline, up to 36 weeks after baseline

Study Arms (2)

Exercise

EXPERIMENTAL

Participants have the opportunity to engage in face-to-face and/or online exercise classes

Behavioral: Community Programme

Usual care control

NO INTERVENTION

Participants continue to engage with usual care provided on discharge from the hospital.

Interventions

Community Programme BEHAVIORAL

Participants have the opportunity to engage in face-to-face and/or online exercise classes. Attendance will be recorded.

Exercise

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for stroke rehabilitation as determined by an appropriate healthcare professional (stroke consultant, physiotherapist).
• Clinical diagnosis of a TIA (via the ABCD2) or stroke (NIH Stroke Severity Scale) by a member of the clinical team at HHFT.
• Willingness to take part in HELP Hampshire Stroke Clinic or control
• Cognitive and communication capacity to sufficiently participate in the study

You may not qualify if:

• Immobile
• Age \>90 years
• Contraindications to moderate to vigorous physical activity including;
• Acute or uncontrolled heart failure
• Unstable or uncontrolled angina
• Uncontrolled cardiac dysrhythmia causing symptoms or haemodynamic compromise
• Symptomatic severe aortic stenosis

Sponsors & Collaborators

• University of Winchester: lead
• Hobbs Rehabilitation: collaborator
• Hampshire Hospitals NHS Foundation Trust: collaborator
• University of Southampton: collaborator

Study Sites (1)

University of Winchester

Winchester, SO22 4NR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Simon Jobson, PhD

  University of Winchester

  STUDY DIRECTOR

Central Study Contacts

James Faulkner

CONTACT

+44 (0)1962 624932; James.Faulkner@winchester.ac.uk

Nick Hudson

CONTACT

+44 (0)1962 624932; Nick.Hudson.17@unimail.winchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 11, 2022
• Study Start: May 15, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Starting after 6 months of first publication
• Access Criteria: Available to all researchers interested in stroke rehabilitation research

Locations

GB (1)