Covid19, Post-acute COVID-19 Syndrome
Conditions
Keywords
Respiratory Muscle Training, Tele-rehabilitation, Quality of Life, Exercise
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.
Interventions
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
OTHERInspiratory + expiratory muscle training sham group
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
Participants will perform a cardiovascular exercise program including warm-up, recovery between intervals and return to calm by cycloergometer.
Sponsors
Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in respiratory muscle function | Baseline and 1-week post-intervention (9 weeks from baseline) | 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 |
| Change in physical function | Baseline and 1-week post-intervention (9 weeks from baseline) | 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) |
| Change in pulmonary function | Baseline and 1-week post-intervention (9 weeks from baseline) | Change in pulmonary function and diffusion capacity for carbon monoxide between baseline and post-intervention, as measured by pulmonary function tests |
| Change in psychological status | Baseline and 1-week post-intervention (9 weeks from baseline) | Change in anxiety/depression levels between baseline and post-intervention, as measured by Hospital Anxiety and Depression Scale |
Countries
Spain
Outcome results
None listed