Clinical trial NCT05575102: Walking Football for People With Chronic Breathlessness
Official title: Walking Football for People With Chronic Breathlessness: a Mixed-methods Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Keywords: Dyspnea
Chronic Breathlessness
Football
Walking
Exercise
Physical Activity
Pulmonary Rehabilitation
Feasibility
Chronic Obstructive Pulmonary Disease
Lead sponsor: Teesside University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 6
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment and Consent Rate
timeFrame: 6-Months
measure: Completion Rate
timeFrame: 6-Weeks
measure: Methodology and Intervention Acceptability
timeFrame: 10-Weeks
measure: Adverse Events
timeFrame: 6-Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: Tesside University
Study officials:
affiliation: Teesside University
name: Samantha Harrison
role: PRINCIPAL_INVESTIGATOR
References: