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Completed

NCT Number: NCT05597774

Effects of Respiratory Muscle Training 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.

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Key information

Conditions

Covid19 Behavior COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Motor Activity Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario 12 de Octubre de Madrid

Madrid, 28041, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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 program

Other

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

Primary outcomes

  1. 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).

  2. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Colegio de Fisioterapeutas de la Comunidad de Madrid

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2022
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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