Walking Football for People With Chronic Breathlessness

Dyspnea Clinical Trial

Official title:

Walking Football for People With Chronic Breathlessness: a Mixed-methods Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05575102
• Other study ID #: 10814
• Status: Completed
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: December 13, 2023

Study information

• Verified date: April 2024
• Source: Teesside University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 13, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea

Intervention

Other:
• Walking Football
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.

Locations

Country	Name	City	State
United Kingdom	Tesside University	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
Teesside University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment and Consent Rate	Percentage of eligible participants given an information sheet who consent to participate	6-Months
Primary	Completion Rate	Percentage of participants who complete at least four of the available six sessions	6-Weeks
Primary	Methodology and Intervention Acceptability	Percentage of participants who complete all pre-post outcome measurements, intensity outcome measurements, and partake in an interview.	10-Weeks
Primary	Adverse Events	Number of Serious and Minor Adverse Events recorded	6-Weeks