Effects of Respiratory Muscle Training Combined With an Exercise Training Program in Individuals With Long-term Post-COVID-19 Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in quality of life
研究概览
简要总结
The main objective of the present study is to observe the short-term effects of respiratory muscle training combined with an exercise training program on quality of life and exercise tolerance in individuals with long-term post-COVID-19 symptoms. As secondary objectives, the effects on respiratory muscle function, physical and lung function, as well as on the psychological state of these individuals.
详细描述
It is a double-blind randomized clinical trial study. Each participant will be randomly assigned to one of the following groups: 1) Exercise training program + Inspiratory muscle training + Expiratory muscle training, 2) Exercise training program + Sham Inspiratory muscle training + Sham Expiratory muscle training.
The exercise training program will be delivered in hospital and will be applied 2 sessions per week during 8 weeks. The exercise component will be lasted for 1hour and it consisted of cardiovascular exercises.
The respiratory muscle training program will be applied twice a day, 3 sessions per week during 8 weeks by a threshold device. The evening sessions will be supervised by a physiotherapist through a virtual platform.
Participants received baseline assessments at the beginning of the intervention and post-intervention assessments at the end of the 8th week.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years who presented long-term post-COVID-19 symptoms of fatigue and dyspnoea for at least 3 months after the COVID-19 diagnosis
排除标准
- •Progressive respiratory, neuromuscular or neurological disorders and/or psychiatric or cognitive conditions that hindered their ability to cooperate
- •Comorbidity that could interfere with the study interventions
- •Any contraindication to the training interventions
- •Previous inclusion in a rehabilitation program for their long-term post-COVID-19 symptoms (previous 3 months)
研究组 & 干预措施
Exercise training + Inspiratory and expiratory muscle training group
Participants will perform a cardiovascular exercise program 2 days per week during 8 weeks in the hospital, combined with an inspiratory and expiratory muscle training by a threshold device at home, twice a day, 3 days per week, for 8 weeks supervised by a physiotherapist through a virtual platform.
干预措施: Inspiratory + expiratory muscle training group (Other)
Exercise training + Inspiratory and expiratory muscle training group
Participants will perform a cardiovascular exercise program 2 days per week during 8 weeks in the hospital, combined with an inspiratory and expiratory muscle training by a threshold device at home, twice a day, 3 days per week, for 8 weeks supervised by a physiotherapist through a virtual platform.
干预措施: Exercise training program (Other)
Exercise training + Inspiratory and expiratory muscle training sham group
Participants will perform a cardiovascular exercise program 2 days per week during 8 weeks in the hospital, combined with an inspiratory and expiratory muscle training by a sham threshold device at home, twice a day, 3 days per week, for 8 weeks supervised by a physiotherapist through a virtual platform.
干预措施: Inspiratory + expiratory muscle training sham group (Other)
Exercise training + Inspiratory and expiratory muscle training sham group
Participants will perform a cardiovascular exercise program 2 days per week during 8 weeks in the hospital, combined with an inspiratory and expiratory muscle training by a sham threshold device at home, twice a day, 3 days per week, for 8 weeks supervised by a physiotherapist through a virtual platform.
干预措施: Exercise training program (Other)
结局指标
主要结局
Change in quality of life
时间窗: Baseline and 1-week post-intervention (9 weeks from baseline)
Change in quality of life between baseline and post-intervention, as measured by the EuroQol-5D questionnaire which consists of 5 dimensions with 5 response options based on severity level, ranging from 1 to 5. An index score is provided, ranging from 0 (death) to 1 (full health).
Change in exercise tolerance
时间窗: Baseline and 1-week post-intervention (9 weeks from baseline)
Change in exercise tolerance between baseline and post-intervention, as measured by a cardiopulmonary exercise test
次要结局
- Change in respiratory muscle function(Baseline and 1-week post-intervention (9 weeks from baseline))
- Change in physical function(Baseline and 1-week post-intervention (9 weeks from baseline))
- Change in pulmonary function(Baseline and 1-week post-intervention (9 weeks from baseline))
- Change in psychological status(Baseline and 1-week post-intervention (9 weeks from baseline))