Effects of Respiratory Muscle Training in People Who Have Had COVID-19 Disease

Universidad Complutense de Madrid

Status: Completed

Conditions: Quality of Life; Respiratory Muscle Training; Covid19; Respiratory Function Test; Psychosocial Factor

Treatments: Other: Inspiratory + expiratory muscle training group; Other: Inspiratory + expiratory muscle training placebo group; Other: Inspiratory muscle training placebo group; Other: Inspiratory muscle training group

Study type: Interventional

Funder types: Other

Identifiers

NCT04734561

20/715-E_BS

Details and patient eligibility

About

The main objective of the present study is to observe the short-term effects of respiratory muscle training applied by telerehabilitation on quality of life and exercise tolerance in people who have had the COVID-19 disease. As secondary objectives, the effects on respiratory muscles strength/tolerance, pulmonary function and psychological and cognitive factors.

Full description

It is a double-blind randomized clinical trial study. Each participant will be randomly assigned to one of the following groups: 1) Inspiratory muscle training, 2) Placebo Inspiratory muscle training, 3) Inspiratory muscle training + Expiratory muscle training, 4) Placebo Inspiratory muscle training + Expiratory muscle training.

Each exercise training program will be applied twice per day 7 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, at the end of the 4th week, and post-intervention assessments at the end of the 8th week.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive diagnosis of COVID-19 (SARS-CoV2)
• Hospital admission for COVID-19 in the last 3 months
• Stable phase and home discharge;

Exclusion criteria

• Severe cognitive impairment
• Any type of musculoskeletal, neurological, cardiac or respiratory disease where training is contraindicated
• Inability to carry out the training program through telematic supervision.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 4 patient groups

Inspiratory muscle training group

Experimental group

Description:

Participants will perform an inspiratory muscle training by a threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.

Treatment:

Other: Inspiratory muscle training group

Inspiratory muscle training placebo group

Sham Comparator group

Description:

Participants will perform an inspiratory muscle training by a placebo threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.

Treatment:

Other: Inspiratory muscle training placebo group

Inspiratory + expiratory muscle training group

Experimental group

Description:

Participants will perform an inspiratory and expiratory muscle training by a threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.

Treatment:

Other: Inspiratory + expiratory muscle training group

Inspiratory + expiratory muscle training placebo group

Sham Comparator group

Description:

Participants will perform an inspiratory and expiratory muscle training by a placebo threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.

Treatment:

Other: Inspiratory + expiratory muscle training placebo group