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Completed

NCT Number: NCT05575102

Walking Football for People With Chronic Breathlessness

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.

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Key information

Conditions

Dyspnea Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tesside University

Middlesbrough, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking Football

Other

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.

Primary outcomes

  1. Recruitment and Consent Rate

    Time frame: 6-Months

    Percentage of eligible participants given an information sheet who consent to participate

  2. Completion Rate

    Time frame: 6-Weeks

    Percentage of participants who complete at least four of the available six sessions

  3. 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.

  4. Adverse Events

    Time frame: 6-Weeks

    Number of Serious and Minor Adverse Events recorded

Sponsors and collaborators

Lead sponsor

Teesside University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 12, 2022
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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