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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Rehabilitation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34440
    • Istanbul Bilgi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulmonary Rehabilitation; 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; Chest and diaphragm respiration, in-house mobilization, joint range of motion exercises was performed to the patients as breathing exercises.
Placebo Comparator: Control; 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; Chest and diaphragm respiration, in-house mobilization, joint range of motion exercises was performed to the patients as breathing exercises.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul Bilgi University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2020
• Primary Completion (Actual): April 10, 2020
• Study Completion (Actual): April 26, 2020

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: April 26, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 26, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Fatigue; Pulmonary Rehabilitation; Dyspnea
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PR COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No