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

Universidad Complutense de Madrid

Status: Completed

Conditions: Post-acute COVID-19 Syndrome; Covid19

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05597774

21/747

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

Exercise training + Inspiratory and expiratory muscle training group

Experimental group

Description:

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.

Treatment:

Other: Inspiratory + expiratory muscle training group

Other: Exercise training program

Exercise training + Inspiratory and expiratory muscle training sham group

Sham Comparator group

Description:

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.

Treatment:

Other: Inspiratory + expiratory muscle training sham group

Other: Exercise training program