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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05597774
• Other study ID #: 21/747
• Status: Completed
• Phase: N/A
• Start date: October 28, 2022
• Est. completion date: September 22, 2023

Study information

• Verified date: September 2022
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Inspiratory + expiratory muscle training group
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
• Inspiratory + expiratory muscle training sham group
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
• Exercise training program
Participants will perform a cardiovascular exercise program including warm-up, recovery between intervals and return to calm by cycloergometer.

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre de Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)