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

NCT05597774 | Completed

• 1 other identifier: 21/747
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Post-acute COVID-19 Syndrome

Keywords

Respiratory Muscle Training; Tele-rehabilitation; Quality of Life; Exercise

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (4)

• Change in respiratory muscle function

  Baseline and 1-week post-intervention (9 weeks from baseline)

• Change in physical function

  Baseline and 1-week post-intervention (9 weeks from baseline)

• Change in pulmonary function

  Baseline and 1-week post-intervention (9 weeks from baseline)

• Change in psychological status

  Baseline and 1-week post-intervention (9 weeks from baseline)

Study Arms (2)

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.

Other: Inspiratory + expiratory muscle training group; Other: Exercise training program

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.

Other: Inspiratory + expiratory muscle training sham group; Other: Exercise training program

Interventions

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.

Exercise training + Inspiratory and expiratory muscle training group

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.

Exercise training + Inspiratory and expiratory muscle training sham group

Exercise training program OTHER

Participants will perform a cardiovascular exercise program including warm-up, recovery between intervals and return to calm by cycloergometer.

Exercise training + Inspiratory and expiratory muscle training group; Exercise training + Inspiratory and expiratory muscle training sham group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid: collaborator

Study Sites (1)

Hospital Universitario 12 de Octubre de Madrid

Madrid, 28041, Spain

Location

Related Publications (3)

• 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.

  PMID: 35236727 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.

  PMID: 35203084 BACKGROUND

• 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.

  PMID: 39798250 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Motor Activity

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Ibai López de Uralde, PhD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 28, 2022
• Study Start: October 28, 2022
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: September 28, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)