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| Name | Class |
|---|---|
| Colegio de Fisioterapeutas de la Comunidad de Madrid | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training + Inspiratory and expiratory muscle training group | Experimental | 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. |
|
| Exercise training + Inspiratory and expiratory muscle training sham group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory + expiratory muscle training group | Other | Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ibai López de Uralde, PhD | Universidad Complutense de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 de Octubre de Madrid | Madrid | 28041 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35236727 | Background | McNarry MA, Berg RMG, Shelley J, Hudson J, Saynor ZL, Duckers J, Lewis K, Davies GA, Mackintosh KA. Inspiratory muscle training enhances recovery post-COVID-19: a randomised controlled trial. Eur Respir J. 2022 Oct 6;60(4):2103101. doi: 10.1183/13993003.03101-2021. Print 2022 Oct. | |
| 35203084 | Background | Nopp S, Moik F, Klok FA, Gattinger D, Petrovic M, Vonbank K, Koczulla AR, Ay C, Zwick RH. Outpatient Pulmonary Rehabilitation in Patients with Long COVID Improves Exercise Capacity, Functional Status, Dyspnea, Fatigue, and Quality of Life. Respiration. 2022;101(6):593-601. doi: 10.1159/000522118. Epub 2022 Feb 24. |
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| Inspiratory + expiratory muscle training sham group | Other | Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm. |
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| Exercise training program | Other | Participants will perform a cardiovascular exercise program including warm-up, recovery between intervals and return to calm by cycloergometer. |
|
| 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) |
| 39798250 | Derived | Del Corral T, Fabero-Garrido R, Plaza-Manzano G, Izquierdo-Garcia J, Lopez-Saez M, Garcia-Garcia R, Lopez-de-Uralde-Villanueva I. Effect of respiratory rehabilitation on quality of life in individuals with post-COVID-19 symptoms: A randomised controlled trial. Ann Phys Rehabil Med. 2025 Feb;68(1):101920. doi: 10.1016/j.rehab.2024.101920. Epub 2025 Jan 11. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000094024 | Post-Acute COVID-19 Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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