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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365738
• Other study ID #: PR COVID-19
• Status: Completed
• Phase: N/A
• Start date: March 11, 2020
• Est. completion date: April 26, 2020

Study information

• Verified date: April 2020
• Source: Istanbul Bilgi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: April 26, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Infection

Intervention

Other:
• Rehabilitation
Chest and diaphragm respiration, in-house mobilization, joint range of motion exercises was performed to the patients as breathing exercises.

Locations

Country	Name	City	State
Turkey	Istanbul Bilgi University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Bilgi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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