Does a 4-week Inspiratory Muscle Training Intervention (IMT) Increase Inspiratory Muscle Pressure (MIP) and Other Functional Outcomes in People With Long COVID? A Pilot Investigation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Maximal inspiratory muscle pressure (MIP) at week 4.
研究概览
简要总结
This pilot investigation will recruit people with Long COVID to participate in a 4 week individualized inspiratory muscle training intervention with pre and post spirometry testing and additional functional outcomes to assess the effectiveness of the intervention.
详细描述
The study design is a 4 - week parallel-arm intervention, randomised controlled trial. Participants will attend 2 testing days, baseline and follow-up 4 weeks apart.
Participants will first be screened over the phone to assess eligibility. Participants will then be randomly allocated using minimisation, into either control or intervention arm.
Baseline testing:
Participants will undergo baseline testing in the laboratory.
Participants will be measured for their anthropometrics; height and weight. Participants will complete a series of questionnaires for 15 mins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experiencing self reported Dyspnea (Breathlessness) following COVID-19 infection over 3 months ago.
- •Aged between 18 and 65
排除标准
- •Are pregnant
- •Receiving treatment following a previous cardiac event (Myocardial-infarction and Non-ST elevation MI),
- •Have a dementia diagnosis,
- •Have a high risk of falls,
- •Have an additional chronic respiratory disease diagnosis such as (Chronic obstructive pulmonary disease) COPD or CF (cystic fibrosis)
- •Are receiving respiratory muscle training
- •Are receiving steroid inhaler treatment
研究组 & 干预措施
Control
Participants will arrive at the Laboratory and complete a series of questionnaires: general physical activity, BDI, TDI, PSQI, General health questionnaire, Post COVID fatigue scale, EQ 5D-5L. They will undergo spirometry testing FEV1, MIP and PEF. Participants will undergo a 6 minute walk test and a Sub-maximal exercise test (CPET) using a cycle ergometer (15W/min) until an RPE of 17.
Participants continue usual life between baseline and follow up testing. Participants will have 1 call per week where MIP is measured using a Care fusion hand held spirometer device.
After 4 weeks, participants will return to the Laboratory and repeat baseline testing.
Inspiratory Muscle training intervention
Participants will arrive at the Laboratory and complete a series of questionnaires: general physical activity, BDI, TDI, PSQI, General health questionnaire, Post COVID fatigue scale, EQ 5D-5L. They will undergo spirometry testing FEV1, MIP and PEF. Participants will undergo a 6 minute walk test and a Sub-maximal exercise test (CPET) using a cycle ergometer (15W/min) until an RPE of 17.
Participants undergo inspiratory muscle training for 4 weeks between baseline and follow up testing. They will be given a PrO2 device where the intervention will be 3 times per week for 4 weeks. Each session will be 6x6 breaths at 80% MIP. Participants will have 1 call per week where MIP is measured using a Care fusion hand held spirometer device.
After 4 weeks, participants will return to the Laboratory and repeat baseline testing.
干预措施: PrO2 (Device)
结局指标
主要结局
Change in Maximal inspiratory muscle pressure (MIP) at week 4.
时间窗: Baseline, and week 4
Maximal inspiratory muscle pressure (cmH20)
次要结局
- Change in Peak expiratory flow (PEF) at week 4.(Baseline, and week 4)
- Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI).(Baseline, and week 4)
- Change in Ventilatory threshold (VT) at week 4.(Baseline, and week 4)
- Change in 6 minute walk test distance at week 4(Baseline, and week 4)
- Change in Forced ventilatory equivalent 1 second (FEV1) at week 4(Baseline, and week 4)
研究者
Rachel Eddy
Principle Investigator
University of Bath