跳至主要内容
临床试验/NCT05575102
NCT05575102已完成不适用

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

Teesside University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
1
主要终点
Adverse Events

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Adverse Events

时间窗: 6-Weeks

Number of Serious and Minor Adverse Events recorded

Methodology and Intervention Acceptability

时间窗: 10-Weeks

Percentage of participants who complete all pre-post outcome measurements, intensity outcome measurements, and partake in an interview.

Recruitment and Consent Rate

时间窗: 6-Months

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

Completion Rate

时间窗: 6-Weeks

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samantha Harrison

Professor of Respiratory Rehabilitation

Teesside University

研究点 (1)

Loading locations...

相似试验