- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05575102
Walking Football for People With Chronic Breathlessness
Walking Football for People With Chronic Breathlessness: a Mixed-methods Feasibility Study
The objective of this study is to evaluate the feasibility of a walking football intervention for people with chronic breathlessness. Chronic breathlessness refers to breathlessness that persists despite optimal treatment of the underlying pathophysiology. Roughly 9-13% of the general population will experience chronic breathlessness, with incidence rising with age to 37% for those aged over 60years.
This mixed-methods study will offer patients who have enrolled on to pulmonary rehabilitation (PR) the prospect to partake in walking football once they have completed their scheduled programmes (or voluntarily dropped-out); introducing a potential opportunity for long-term exercise maintenance post PR. Participants will be recruited from North Tees & Hartlepool Foundation Trust, and South Tees Foundation Trust.
PR is recommended for all people with chronic breathlessness and has been shown to improve exercise capacity and health-related quality of life. However, PR programmes typically only last for 6-12 weeks, and have little to no impact on long-term physical activity levels. Walking Football has been identified as a potential form of exercise which people with breathlessness could maintain post-PR, thus offering a solution to PRs limited ability to promote exercise maintenance.
Participants will be invited to play walking football for 6-weeks (2-hours weekly) in the Middlesbrough/Stockton area. Before and after weeks 1 and 6, breathlessness-relevant outcomes will be measured including; exercise capacity, lower-limb strength, perceived breathlessness, quality of life, balance confidence, depression, and anxiety.
During a participant's third session, one-time physical intensity outcomes will be calculated during play including heart-rate and perceived intensity. Participants will also be invited to an interview to discuss how feasible they have found the football, any benefits they may have experienced, and how the football programme could be improved.
The study will officially end with a co-production workshop; a focus group with stakeholders (players, physiotherapists, co-ordinators, researchers) after preliminary analysis has been conducted to discuss initial findings.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Middlesbrough, United Kingdom
- Tesside University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Confirmed diagnosis of chronic breathlessness via a chronic respiratory condition (through referral to PR)
- Example conditions include; COPD, severe asthma, Pulmonary Fibrosis, Lung Disease (This does not include Long Covid as many patients often make a full recovery over time).
- Be 35 years or over at the point of recruitment
- Scheduled PR programme ends within the recruitment window
- Be able to communicate with good verbal English or use adaptive equipment to communicate
- Respiratory condition is stable (e.g. six weeks clear of exacerbation in COPD)
Exclusion Criteria:
- Unstable Angina
- Other conditions that may affect balance (e.g. neurological)
- Recent exacerbation of COPD (within the last six weeks)
- Unable to provide written informed consent
- Unable to speak English or no translation options available
- Any other acute health conditions that would make activity unsafe e.g. acute infection
Study Plan
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: Walking Football
Walking football intervention for 6-weeks (2-hour per week) at a local sports hall, supervised by a walking football coach with assistance from CB.
|
Walking Football (Soccer): Typical football rules apply but without running. Participants will play at a local sports hall for 6-weeks, (2-hour per week). Time will be split between warm-up, football practice drills, and small-sided games. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment and Consent Rate
Time Frame: 6-Months
|
Percentage of eligible participants given an information sheet who consent to participate
|
6-Months
|
|
Completion Rate
Time Frame: 6-Weeks
|
Percentage of participants who complete at least four of the available six sessions
|
6-Weeks
|
|
Methodology and Intervention Acceptability
Time Frame: 10-Weeks
|
Percentage of participants who complete all pre-post outcome measurements, intensity outcome measurements, and partake in an interview.
|
10-Weeks
|
|
Adverse Events
Time Frame: 6-Weeks
|
Number of Serious and Minor Adverse Events recorded
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6-Weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samantha Harrison, Teesside University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10814 (DAIDS ES)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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