Post COVID REspiratory Mechanisms and the Efficacy of a Breathing Exercise Intervention for DYsregulated Breathing (REMEDY): COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Breathlessness.
研究概览
简要总结
A pilot Study
To investigate the efficacy of a breathing intervention for improving persistent breathlessness due to dysregulated breathing following COVID-19 when compared to usual care.
详细描述
Pilot RCT for upto 60 subjects across 2 arms
Intervention A 12 session/six week, twice a week online group-based intervention based on breathing techniques including yoga practice directed by a specialist. Each group will aim for between 3- 6 participants.
Each online session will be circa 40-50 minutes in length. This will include an Introduction and warm up; Breathing practice including yogic breathing and a final cool down and relaxation.
Sessions will run at set times to ensure efficient use of resources but will try to accommodate different time points periods of the day when patients might be functioning best.
Comparator A six week non-intervention (usual care) period will be recruited to, allowing a comparison to the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomisation will be completed in a 1:1 ratio (Intervention: Usual Care) using a sealed envelope block randomisation process.
The study will be single blinded and controlled through the use of a distinct intervention team and an outcomes team.
The intervention team will manage the randomisation and intervention session and planning. The outcomes team will be blinded to the intervention or usual care.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either hospitalised or non-hospitalised with confirmed COVID-19 acute infection.
- •Received a comprehensive clinical respiratory assessment
- •Persisting (>12 weeks) self-reported breathlessness (on CRQ-D) following COVID-19 and confirmed dysregulated breathing (Nijmegen Questionnaire score NQ >23)
- •Age 18 - 80 years of age
- •Ability to give informed consent
- •Able to understand and speak English language
排除标准
- •Severe mood disturbance that limits engagement with the intervention and study outcomes
- •No access to online delivery and/or IT illiterate
- •Significant diagnosed Myalgic Encephalitis/Fibromyalgia/Chronic Fatigue Syndrome prior to developing COVID-19
- •Severe asthma or other chronic lung disease prior to COVID-19
研究组 & 干预措施
Breathing Techniques Intervention
A 12 session/six week, twice a week online group-based intervention based on breathing techniques including yoga practice directed by a specialist. Each group will aim for between 3- 6 participants.
干预措施: Breathing techniques over 12 sessions / 6 weeks inc yoga (Other)
Usual Care
A six week non-intervention (usual care) period will be recruited to, allowing a comparison to the intervention.
结局指标
主要结局
Breathlessness.
时间窗: 7 weeks
Chronic Respiratory Disease Questionnaire - Dyspnoea Domain Range 1-7 with lower - worse
Function
时间窗: 7 weeks
5 repetition chair to stand. Range 0-120 seconds with longer worse
次要结局
- Nijmegen Questionnaire(7 weeks)
- Chalder Fatigue Score(7 weeks)
- Borg Scale of Breathlessness(7 weeks)
- Capnography - in some volunteers(7 weeks)
- Dyspnoea-12 Questionnaire(7 weeks)
- Modified Minnesota Physical Activity(7 weeks)
- Four metre Gait speed(7 weeks)
- EQ5D Quality of Life score(7 weeks)
- Adherence(7 weeks)
- Breath hold, Respiratory rate(7 weeks)