A Pilot Feasibility, Multi-centre, Randomised Controlled Trial of Balance Training Following Pulmonary Rehabilitation on Balance in People With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 77
- 试验地点
- 3
- 主要终点
- Feasibility of study procedures and the delivery of S4S.
研究概览
简要总结
This study aims to see if a co-designed balance training programme called Sport4Steadiness (S4S), is acceptable to people with COPD and if the study procedures, including recruitment and the collection of outcomes, is feasible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statisticians are partially blinded
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with spirometry confirmed diagnosis of COPD as per GOLD guidelines (FEV1/FVC ratio below 0.7) or physician confirmed COPD diagnosis
- •Answers yes to one or more of the Three Key Questions* or Timed up and Go Test result > 11 seconds
- •An ability and capacity to provide consent to the trial
- •Have you fallen in the past year? Q
- •Do you feel unsteady when standing or walking? Q
- •Do you have worries about falling?
排除标准
- •Any neurological, musculoskeletal, chronic pain or other diagnoses that, in the opinion of the investigator, would interfere with the ability of the participant to safely complete PR and balance training
- •Unable to comprehend instruction given verbally in English language
- •Where there is concern that the primary cause of balance issues could be due to problems with visual function, vestibular disturbance or peripheral neuropathy
- •Diagnosis of, or patient-reported symptoms of, vasovagal syncope
研究组 & 干预措施
Usual care
Participants randomised to this arm will continue with their home based exercise programme provided by pulmonary rehabilitation as part of usual care
Sport4Steadiness Programme
A balance training programme post pulmonary rehabilitation
干预措施: Sport4Steadiness (Other)
结局指标
主要结局
Feasibility of study procedures and the delivery of S4S.
时间窗: Outcomes are assessed at the end of recruitment, post-randomisation, and approximately 12 weeks after baseline assessment
The primary feasibility outcomes include participant recruitment rates per site, participants' willingness to be randomised, participant attrition rates, and participant adherence rates.
次要结局
未报告次要终点
研究者
Samantha Harrison
Professor
Teesside University