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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-28

Study Completion Date

2023-09-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid19 Post-acute COVID-19 Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Inspiratory + expiratory muscle training group

Intervention Type OTHER

Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.

Exercise training program

Intervention Type 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 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.

Group Type SHAM_COMPARATOR

Inspiratory + expiratory muscle training sham group

Intervention Type OTHER

Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.

Exercise training program

Intervention Type OTHER

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

Interventions

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Inspiratory + expiratory muscle training group

Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.

Intervention Type 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.

Intervention Type OTHER

Exercise training program

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No