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

NCT04972864 | Completed

• 1 other identifier: 203
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

COVID-19; inspiratory muscle training; respiratory muscle training; exercise

Outcome Measures

Primary Outcomes (8)

• Functional exercise capacity

  Functional exercise capacity was evaluated with the 6-minute walk test according to the European Respiratory Society and American Thoracic Society (ATS/ERS) criteria. Patients were asked to walk as fast as possible at their own walking pace for 6 minutes on a 30-meter straight corridor. Oxygen saturation and heart rate (Beurer pulse oximeter, Ulm, Germany), respiratory frequency, Respiratory frequency, dyspnea, fatigue and leg fatigue perception (modified Borg scale)were recorded before and after the test and during 1 minute recovery.

  First day

• 30 second sit and stand test

  It is a test that evaluates the 30 seconds sit-to-stand activity (30 STS), lower extremity strength and dynamic balance of the patient. The number of times the patient sits and stands in 30 seconds gives the score of the test.

  First day

• International Physical Activity Questionnaire-short form

  Physical activity level was evaluated with Turkish valid and reliable International Physical Activity (IPAQ) questionnaire. The questionnaire consisting of 7 questions gives information about the time spent in walking, moderate-to-vigorous and vigorous activities. The time spent sitting is considered as a separate question. A score is obtained in total score metabolic equivalent (MET)-minutes. According to the result, physical activity level is classified as 'inactive', 'minimally active' and 'very active' .

  First day

• Numerical Evaluation Scale-Pain

  The Numeric Rating Scale (NRS) was used to determine the pain level of the patients at rest, activity and at night. Patients are asked to mark the numbers between 0 and 10 at the time of assessment, in terms of rest, activity and night pain.

  First day

• Nottingham Health Profile

  The assessment of quality of life was assessed with the Nottingham Health Profile (NHP). The questionnaire consists of 38 items and 6 subgroups. There is a possible score limit for each subgroups, ranging from 0-100. 0 indicates no restrictions, 100 indicates presence of all listed restrictions.

  First day

• Hospital Anxiety and Depression Scale

  A valid and reliable Turkish Hospital Anxiety and Depression Scale (HADS) was used to determine the anxiety and depression levels of the patients. In the questionnaire consisting of a total of 14 questions, odd-numbered questions assess anxiety and even-numbered questions assess depression. It has two subgroups, anxiety (HADS-A) and depression (HADS-D). The lowest score that patients can get from both subgroups is 0, and the highest score is 21.

  First day

• Modified Medical Research Council Dyspnea Scale

  Assessment of dyspnea was assessed with the Modified Medical Research Council (MMRC) dyspnea scale. The MMRC is a category scale consisting of 5 statements about dyspnea, scored between 0-4.

  First day

• Fatigue Severity Scale

  It was evaluated with the Fatigue Severity Scale (FSS). It is a scale used by the individual to determine the perception of fatigue. The scale consists of nine items, each item is scored between 1-7. An increase in the total score obtained from the scale indicates that the severity of fatigue of the individual increases

  First day

Study Arms (2)

Exercise training group

ACTIVE COMPARATOR

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.

Other: Exercise training group

Control training group

PLACEBO COMPARATOR

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.

Other: Control training group

Interventions

Exercise training group OTHER

A regular advanced exercise program was given and followed.

Exercise training group

Control training group OTHER

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

Control training group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Çankaya, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Motor Activity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Deran OSKAY, Prof

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 22, 2021
• Study Start: March 1, 2021
• Primary Completion: July 18, 2021
• Study Completion: July 18, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

TU (1)