Effects of Respiratory Muscle Training in Individuals With Long-term Post-COVID-19 Symptoms
- Conditions
- Covid19Post-acute COVID-19 Syndrome
- Registration Number
- NCT05597774
- Lead Sponsor
- Universidad Complutense de Madrid
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hospital Universitario 12 de Octubre de Madrid
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre de Madrid🇪🇸Madrid, Spain