Effects of Respiratory Muscle Training in Individuals With Long-term Post-COVID-19 Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Respiratory Muscle Training Combined With an Exercise Training Program in Individuals With Long-term Post-COVID-19 Symptoms

Conditions
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Covid19, Post-acute COVID-19 Syndrome

Intervention / Treatment
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* Other: Inspiratory + expiratory muscle training group
* Other: Inspiratory + expiratory muscle training sham group
* Other: Exercise training program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training + Inspiratory and expiratory muscle training group<br>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. | Other: Inspiratory + expiratory muscle training group<br>* Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.<br>Other: Exercise training program<br>* Participants will perform a cardiovascular exercise program including warm-up, recovery between intervals and return to calm by cycloergometer.<br>|
| Sham Comparator: Exercise training + Inspiratory and expiratory muscle training sham group<br>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. | Other: Inspiratory + expiratory muscle training sham group<br>* Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.<br>Other: Exercise training program<br>* Participants will perform a cardiovascular exercise program including warm-up, recovery between intervals and return to calm by cycloergometer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | 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). | Baseline and 1-week post-intervention (9 weeks from baseline) | 
| Change in exercise tolerance | Change in exercise tolerance between baseline and post-intervention, as measured by a cardiopulmonary exercise test | Baseline and 1-week post-intervention (9 weeks from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in respiratory muscle function | Change in inspiratory/expiratory muscle strength and inspiratory muscle endurance between baseline and post-intervention, as measured by maximum static inspiratory and expiratory pressures and by a constant load breathing test | Baseline and 1-week post-intervention (9 weeks from baseline) | 
| Change in physical function | Change in lower and upper limb strength between baseline and post-intervention, as measured by 1-min Sit-to-Stand and peripheral muscle force (dynamometry) | Baseline and 1-week post-intervention (9 weeks from baseline) | 
| Change in pulmonary function | Change in pulmonary function and diffusion capacity for carbon monoxide between baseline and post-intervention, as measured by pulmonary function tests | Baseline and 1-week post-intervention (9 weeks from baseline) | 
| Change in psychological status | Change in anxiety/depression levels between baseline and post-intervention, as measured by Hospital Anxiety and Depression Scale | Baseline and 1-week post-intervention (9 weeks from baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Muscle Training, Tele-rehabilitation, Quality of Life, Exercise