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

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
Istanbul Bilgi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Pulmonary Rehabilitation, Dyspnea, Fatigue, Pain, Anxiety

Eligibility Criteria

28 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Bilgi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pulmonary Rehabilitation

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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
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

Full Information

First Posted
April 26, 2020
Last Updated
April 26, 2020
Sponsor
Istanbul Bilgi University
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1. Study Identification

Unique Protocol Identification Number
NCT04365738
Brief Title
Pulmonary Rehabilitation in Post-Acute Period of COVID-19 Infection
Official Title
Pulmonary Rehabilitation in Post-Acute Period of COVID-19 Infection: Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
April 10, 2020 (Actual)
Study Completion Date
April 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Bilgi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Pulmonary Rehabilitation, Dyspnea, Fatigue, Pain, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
Chest and diaphragm respiration, in-house mobilization, joint range of motion exercises was performed to the patients as breathing exercises.
Primary Outcome Measure Information:
Title
Dyspnea
Description
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
Time Frame
Baseline, up to 4 weeks
Secondary Outcome Measure Information:
Title
Chest expansion
Description
Chest expansion was evaluated by measuring the difference between the maximum inspiration and maximum expiration from the level of xsphoid processus of the patients.
Time Frame
Baseline, up to 4 weeks
Title
Fatigue severity
Description
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
Time Frame
Baseline, up to 4 weeks
Title
Visual Analog Scale for pain
Description
Patients were instructed and asked to give a score between 0-10 with 0 equating to no pain, 10 indicating severe pain
Time Frame
Baseline, up to 4 weeks
Title
Hospital anxiety and depression scale
Description
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
Time Frame
Baseline, up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomri̇s Duymaz
Organizational Affiliation
Istanbul Bilgi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Bilgi University
City
Istanbul
ZIP/Postal Code
34440
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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