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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
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.
Hospital Universitario 12 de Octubre de Madrid
Madrid, Spain
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).
Time frame: 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
Time frame: Baseline and 1-week post-intervention (9 weeks from baseline)
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
Time frame: 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)
Time frame: 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
Time frame: 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
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Time frame: Baseline and 1-week post-intervention (9 weeks from baseline)