Effects of Respiratory Muscle Training Combined With an Exercise Training Program in Individuals With Long-term Post-COVID-19 Symptoms
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Universidad Complutense de Madrid
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Change in quality of life
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Change in quality of life
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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))