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

NCT ID: NCT04972864

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-07-18

Brief Summary

The coronavirus disease 2019 (COVID-19) outbreak first appeared in Wuhan, China's Hubei Province in December 2019 and has quickly turned into a worldwide pandemic. As of 28 July 2020, 16,465,707 cases of COVID-19 have been reported. COVID-19 is a highly contagious respiratory disease that causes respiratory, physical and psychological dysfunction in patients.

Severe respiratory symptoms have been observed in COVID-19 patients. Fever (88.7%), cough (57.6%) and shortness of breath (45.6%) were observed in an average of 81% of the patients. However, patients with comorbidities such as hypertension and diabetes, usually over 65 years of age, may have very serious pulmonary sequelae of the infection. Due to lung fibrosis as a result of pneumonia in COVID-19, some patients experience severe respiratory failure requiring pulmonary rehabilitation. In the study of Complaints such as peripheral and respiratory muscle weakness, shortness of breath on exertion, and decreased exercise capacity may be seen in patients who have had COVID-19. In addition, while anxiety and depression increase, quality of life may decrease. In a study conducted with geriatric patients who had COVID-19 and were discharged; Peripheral and respiratory muscle strengthening exercises were given to the patient after discharge, and as a result of the study, it was found that the patient's walking distance and cough strength increased, while the complaints of shortness of breath, anxiety and depression decreased significantly. As a result of this; We can say that while shortness of breath, anxiety-depression and complications are reduced with the pulmonary rehabilitation program in patients with pulmonary involvement who have had COVID-19, participation in daily life activities and quality of life increase.

Telerehabilitation is an emerging method that aims to provide rehabilitation to patients and clinicians by reducing barriers such as distance, time and cost by using information and communication technologies. Telerehabilitation enables patients who cannot access rehabilitation due to geographic, economic or physical disabilities to benefit from rehabilitation services. At the same time, the importance of social distance is emphasized for the continuation of the pandemic process and protection from the highly contagious COVID-19 infection.

Detailed Description

Outpatients with pulmonary involvement who have had COVID-19 was included in the study. Patients who had COVID-19 and pulmonary problems was divided into two groups as randomized controlled. Individuals in the first group was given respiratory exercises (diaphragmatic breathing, thoracic expansion, exercises to increase chest compliance with respiratory control with exercise band and leg strengthening exercises) and inspiratory muscle training with the Threshold IMT (T-IMT) device. The T-IMT (Threshold IMT, Respironics, USA) is a device that provides the same pressure with each breath for the strength and endurance of the inspiratory muscles, regardless of whether the patient is breathing rapidly or slowly. This device provides a constant pressure during inspiration with its flow-independent one-way valve. At the same time, the tool has an adjustable pressure mechanism. The instrument consists of the pressure section, the mouthpiece and the nose clip. When the patient breathes deeply, a constant pressure is applied to inspiration by the valve and the respiratory muscles are strengthened. In the study, individuals was divided into two groups by randomization method. In the first group, inspiratory muscle training was applied for 30 minutes, 3 times a day, 7 days a week for 6 weeks. In practice, individuals was asked to sit in a relaxed upper chest and shoulders position. After the nose clip was in place, the patient was taught to inhale and exhale by closing their lips tightly around the mouthpiece of the instrument. After 8-10 breathing cycles, the patient was asked to continue this cycle for 10 minutes at a time, by checking the breathing for 3-4 breaths. The presence of symptoms such as dizziness, fatigue and shortness of breath was also questioned during the training. In the second group; only breathing exercises (diaphragmatic breathing, thoracic expansion, exercises to increase chest compliance with respiratory control with exercise band, and leg strengthening exercises) was given and a youtube video was sent to the patients so that they could follow the exercises and they was interviewed regularly every week. In the second group; breathing exercises (diaphragmatic breathing, thoracic expansion, exercises to increase chest compliance with respiratory control with exercise band and leg strengthening exercises) was taught and only the exercise link with these exercises was sent.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Exercise training group

Individuals in the treatment group were given respiratory exercises (diaphragmatic breathing, thoracic expansion, exercises to increase chest compliance with respiratory control with exercise band and leg strengthening exercises) and inspiratory muscle training with the Threshold IMT (T-IMT) device. Inspiratory muscle training was applied for 30 minutes, 3 times a day, 7 days a week for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Exercise training group

Intervention Type: OTHER

A regular advanced exercise program was given and followed.

Control training group

Breathing exercises (diaphragmatic breathing, thoracic expansion, exercises to increase chest compliance with respiratory control with exercise band and leg strengthening exercises) were taught in the control group and only the exercise link containing these exercises was sent.

Group Type: PLACEBO_COMPARATOR

Control training group

Intervention Type: OTHER

Basic exercises was given at the beginning and did the same exercises

Interventions

Exercise training group

A regular advanced exercise program was given and followed.

Intervention Type: OTHER

Control training group

Basic exercises was given at the beginning and did the same exercises

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients between the ages of 18-65
• Those with a history of COVID-19 and symptomatic pulmonary distress
• Having an acquaintance who has or knows minimum smartphone or computer usage knowledge
• Being literate

Exclusion Criteria

• Patients who cannot cooperate with the assessment
• Those who have orthopedic problems or neurological diseases that will affect the evaluation of functional capacity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Fulden Sarı

Msc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deran OSKAY, Prof

Role: STUDY_DIRECTOR

Gazi University

Locations

Gazi University

Çankaya, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

203

Identifier Type: -

Identifier Source: org_study_id