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

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-25

Study Completion Date

2024-05-20

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Triple-blind study; the patients will not be informed about training group or control group and they will be evaluated and trained at different places and times.

Evaluations and interventions will be performed different physiotherapist. In addition, before statistical analysis patients' groups will be coded.

Study Groups

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Inspiratory Muscle Training Group

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.

Group Type EXPERIMENTAL

Inspiratory Muscle Training Group

Intervention Type OTHER

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

Patients in the training group inspiratory muscle training will be given 2 sets of 15 minutes a day for a total of 30 minutes/per day or a single session for 30 minutes/week, 7 days/week for a total of 8 weeks.

Patients in the training group will be given respiratory muscle strength training with a home program 6 days a week under the supervision of a physiotherapist 1 day a week.

Control Group

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

Group Type SHAM_COMPARATOR

Control Group

Intervention Type OTHER

Control group will be given breathing exercises 120 times/day, 7days/week, for 8 weeks as home program.

Control group will be followed-up by telephone once a week

Interventions

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Inspiratory Muscle Training Group

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

Patients in the training group inspiratory muscle training will be given 2 sets of 15 minutes a day for a total of 30 minutes/per day or a single session for 30 minutes/week, 7 days/week for a total of 8 weeks.

Patients in the training group will be given respiratory muscle strength training with a home program 6 days a week under the supervision of a physiotherapist 1 day a week.

Intervention Type OTHER

Control Group

Control group will be given breathing exercises 120 times/day, 7days/week, for 8 weeks as home program.

Control group will be followed-up by telephone once a week

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Meral Boşnak Güçlü

Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR