Effects of Inspiratory Muscle Training in Patients With Post COVID-19

Gazi University

Status: Completed

Conditions: COVID-19

Treatments: Other: Control Group; Other: Inspiratory Muscle Training Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05231395

Gazi University-

Details and patient eligibility

About

Coronavirus-2019 (COVID-19) is a new virus that emerged in December 2019 and spread quickly all over the world. Problems such as hypoxia, dyspnea, increased fatigue, decreased exercise capacity and respiratory muscle strength occur in COVID-19 patients.In addition, abnormalities in skeletal muscles due to systemic inflammation, mechanical ventilation, sedation and prolonged bed rest in hospital and intensive care patients cause decreased exercise capacity.

Full description

Dyspnea is one of the most common long-term symptoms in COVID-19 patients. It has been determined that dyspnea that persists three and six months after hospital discharge is associated with peak oxygen consumption in hospitalized and discharged COVID-19 patients, while peak oxygen consumption decreases in patients with dyspnea. Inspiratory muscle training may be an effective treatment modality in the treatment of dyspnea in patients with dyspnea after COVID-19. The effects of inspiratory muscle training have been investigated in different lung diseases. In these studies, inspiratory muscle training increased respiratory muscle strength and endurance, exercise capacity, and quality of life, and decreased fatigue and dyspnea.

The aim of this study is to investigate the effects of inspiratory muscle training on oxygen consumption, muscle oxygenation, physical activity level, respiratory muscle strength and endurance, peripheral muscle strength, functional exercise capacity, dyspnea, fatigue and quality of life in patients with COVID-19.

Primary outcome measurement will be oxygen consumption (cardiopulmonary exercise test).

Secondary outcome will be muscle oxygenation (Moxy device), physical activity level (multi sensor activity device), pulmonary function (spirometer), functional exercise capacity (six-minute walk test), respiratory (mouth pressure device) and peripheral muscle (hand-held dynamometer) strength, inspiratory muscle endurance (incremental threshold loading test), functional status (Post-COVID-19 Functional Status Scale), dyspnea (London Chest Daily Living Activity Scale), fatigue (Fatigue Severity Scale) and quality of life (Saint George Respiratory Questionnaire).

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between the ages of 18-75
• Diagnosed with COVID-19
• COVID-19 Polymerase Chain Reaction (PCR) test result negative
• Volunteer to participate in the study

Exclusion criteria

• Body mass index >35 kg/m2
• Acute pulmonary exacerbation, acute upper or lower respiratory tract infection
• Aortic stenosis, complex arrhythmia, aortic aneurysm
• Serious neurological, neuromuscular, orthopedic, other systemic diseases or other diseases affecting physical functions
• Cognitive impairment that causes difficulty in understanding and following exercise test instructions
• Participated in a planned exercise program in the last three months
• Bulla formation in the lung
• Uncontrolled hypertension and/or diabetes mellitus, heart failure and cardiovascular disease
• Contraindication for exercise testing and/or exercise training according to the American College of Sports Medicine

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Inspiratory Muscle Training Group

Experimental group

Description:

Patients in the training group will be performed inspiratory muscle training with the PowerBreathe® (inspiratory muscle training device) device at 50% of the maximal inspiratory pressure.

Treatment:

Other: Inspiratory Muscle Training Group

Control Group

Sham Comparator group

Description:

Control group will be given breathing exercises as a home program for 8 weeks.

Treatment:

Other: Control Group