Pulmonary Rehabilitation in Post-Acute Period of COVID-19 Infection

Study Overview
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Brief Summary
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The aim of this study is to investigate the efficacy of pulmonary rehabilitation(PR) applied in the isolation processes of post-acute patients with mild and moderate symptoms who had positive COVID-19 test on dyspnea,muscle pain,chest expansion,lower limb muscle strength and dynamic balance,fatigue,anxiety and depression.

Detailed Description
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This study was conducted with 270 patients who were the COVID-19 test was positive and isolated in their homes during post-acute periods.While one of the groups (n=135) was asked to remain isolated at home by providing patient education,a PR program was applied for 4 weeks in addition to the patients in the other group(n=135).PR consists of patient education, breathing, in-house mobilization and range of motion exercises.As the evaluation parameters,pre-treatment and post-treatment dyspnea levels with Borg scale,muscle pain with visual analog scale(VAS),functional capacities with sit-up test,chest expansions with tape measure,respiratory frequency,fatigue level with fatigue severity scale,and emotional status with hospital anxiety and depression(HAD) scale were evaluated.

Official Title
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Pulmonary Rehabilitation in Post-Acute Period of COVID-19 Infection: Prospective Randomized Controlled Trial

Conditions
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COVID-19

Intervention / Treatment
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* Other: Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 28-45, positive COVID-19 test, being in the post-acute period, having symptoms of mild-moderate severity, respiratory rate ≤40 breaths / min, patients who can make video speech Exclusion Criteria: Severe symptom involvement, fever more than 38 degrees, obese patients, patients with multiple comorbidities, patients with one or more organ failure, oxygen saturation in the blood ≤95%, a resting blood pressure of <90/60 mmHg or> 140 / 90 mmHg patients

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary Rehabilitation<br>The patients who applied pulmonary rehabilitation were checked, motivated and followed-up regularly with video calls every day. Pulmonary rehabilitation program consists of patient education, breathing, in-house mobilization and range of motion exercises. | Other: Rehabilitation<br>* Chest and diaphragm respiration, in-house mobilization, joint range of motion exercises was performed to the patients as breathing exercises.<br>|
| Placebo Comparator: Control<br>As a patient education, information was given about the disease and treatment process, listening to the patient during this process and getting regular sleep, balanced nutrition and taking a break from smokers. | Other: Rehabilitation<br>* Chest and diaphragm respiration, in-house mobilization, joint range of motion exercises was performed to the patients as breathing exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea | The Borg scale is a scale scored between 0-10, indicating the severity of dyspnea. 0 indicates no shortness of breath, 10 indicates severe shortness of breath | Baseline, up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest expansion | Chest expansion was evaluated by measuring the difference between the maximum inspiration and maximum expiration from the level of xsphoid processus of the patients. | Baseline, up to 4 weeks | 
| Fatigue severity | Fatigue severity scale is a questionnaire consisting of 9 questions showing the degree of fatigue of patients. An average score of less than 2.8 indicates no fatigue, and more than 6.1 indicates chronic fatigue syndrome | Baseline, up to 4 weeks | 
| Visual Analog Scale for pain | Patients were instructed and asked to give a score between 0-10 with 0 equating to no pain, 10 indicating severe pain | Baseline, up to 4 weeks | 
| Hospital anxiety and depression scale | The HAD scale is a short self administered questionnaire used to screen for anxiety and depression. The questionnaire consists of 14 items, seven each measuring anxiety and seven to measure depression. According to research literature, the cut-off point for elevated anxiety and depression as measured by the HAD scale is eight | Baseline, up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Rehabilitation, Dyspnea, Fatigue, Pain, Anxiety