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

September 27, 2023 updated by: Universidad Complutense de Madrid

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise training + Inspiratory and expiratory muscle training group
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
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
Other: Exercise training program
Participants will perform a cardiovascular exercise program including warm-up, recovery between intervals and return to calm by cycloergometer.
Sham Comparator: Exercise training + Inspiratory and expiratory muscle training sham group
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: Exercise training program
Participants will perform a cardiovascular exercise program including warm-up, recovery between intervals and return to calm by cycloergometer.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life
Time Frame: 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).
Baseline and 1-week post-intervention (9 weeks from baseline)
Change in exercise tolerance
Time Frame: 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
Baseline and 1-week post-intervention (9 weeks from baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in respiratory muscle function
Time Frame: 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
Baseline and 1-week post-intervention (9 weeks from baseline)
Change in physical function
Time Frame: 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)
Baseline and 1-week post-intervention (9 weeks from baseline)
Change in pulmonary function
Time Frame: 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
Baseline and 1-week post-intervention (9 weeks from baseline)
Change in psychological status
Time Frame: 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
Baseline and 1-week post-intervention (9 weeks from baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Collaborators

Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid

Investigators

  • Principal Investigator: Ibai López de Uralde, PhD, Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2022

Primary Completion (Actual)

September 22, 2023

Study Completion (Actual)

September 22, 2023

Study Registration Dates

First Submitted

October 7, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 28, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/747

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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