Effects of Respiratory Muscle Training on Quality of Life, Physical and Pulmonary Function and Psychological Status in Patients Who Have Had COVID-19 Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Exercise tolerance
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 applied by telerehabilitation on quality of life and exercise tolerance in people who have had the COVID-19 disease. As secondary objectives, the effects on respiratory muscles strength/tolerance, pulmonary function and psychological and cognitive factors.
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) Inspiratory muscle training, 2) Placebo Inspiratory muscle training, 3) Inspiratory muscle training + Expiratory muscle training, 4) Placebo Inspiratory muscle training + Expiratory muscle training.
Each exercise training program will be applied twice per day 7 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, at the end of the 4th week, 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive diagnosis of COVID-19 (SARS-CoV2)
- •Hospital admission for COVID-19 in the last 3 months
- •Stable phase and home discharge;
排除标准
- •Severe cognitive impairment
- •Any type of musculoskeletal, neurological, cardiac or respiratory disease where training is contraindicated
- •Inability to carry out the training program through telematic supervision.
研究组 & 干预措施
Inspiratory muscle training group
Participants will perform an inspiratory muscle training by a threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.
干预措施: Inspiratory muscle training group (Other)
Inspiratory muscle training placebo group
Participants will perform an inspiratory muscle training by a placebo threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.
干预措施: Inspiratory muscle training placebo group (Other)
Inspiratory + expiratory muscle training group
Participants will perform an inspiratory and expiratory muscle training by a threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.
干预措施: Inspiratory + expiratory muscle training group (Other)
Inspiratory + expiratory muscle training placebo group
Participants will perform an inspiratory and expiratory muscle training by a placebo threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.
干预措施: Inspiratory + expiratory muscle training placebo group (Other)
结局指标
主要结局
Exercise tolerance
时间窗: Change from Baseline Exercise tolerance at 8 weeks
Exercise tolerance will be evaluated by a test consisted on 30 squats based on three different heart rate measuring moments (resting heart rate, heart rate after exercise, heart rate after longer period) evaluating the speed at which the heart rate increases/decreases.
Health-related quality of life
时间窗: Change from Baseline Health-related quality of life at 8 weeks
To evaluate the health-related quality of life of the participants a valid, reliable and generic questionnaire will be used. It consisted of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension.
次要结局
- Inspiratory muscle endurance(Change from Baseline Inspiratory muscle endurance at 8 weeks)
- Upper limb muscle strength(Change from Baseline Peripheral muscle strength at 8 weeks)
- Maximum respiratory pressures(Change from Baseline Maximum respiratory pressures at 8 weeks)
- Cognitive factors(Change from Baseline cognitive factors at 8 weeks)
- Psychological factors(Change from Baseline Psychological factors at 8 weeks)
- Lung function (forced spirometry)(Change from Baseline Lung function at 8 weeks)
- Lower limb muscle strength(Change from Baseline Lower limb strength at 8 weeks)
研究者
Ibai López de Uralde Villanueva
Professor Ibai López de Uralde Villanueva
Universidad Complutense de Madrid