- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05787353
Cardiopulmonary Rehabilitation for Post-acute COVID-19 Symptoms
Hospital- Versus Home-based Cardiopulmonary Rehabilitation for Post-acute COVID-19 Symptoms
The purpose of this RETROSPECTIVE study was to compare the effect of a hospital and home-based cardiopulmonary rehabilitation (CPR) program on exercise endurance and quality of life in post-acute COVID-19 patients.
88 post-acute COVID-19 patients were divided two groups according to receiving hospital (n=45) or home-based CPR (n=43)in our rehabilitation clinic between January and July 2021. Both protocols consisted of aerobic, breathing and flexibility exercises. Hospital-based CPR: three or four days per week for a total of 20 sessions. Home-based CPR: three or four days/a week over a period of six weeks. The results of six meters walk test (6MWT) for exercise endurance as a main outcome measure, and Borg-dyspnea/fatigue, the visual analog scale (VAS) for pain and the Short Form-36 (SF-36) as secondary outcome measures before and after treatment were recorded.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Odunpazarı
-
Eskişehir, Odunpazarı, Turkey
- Eskisehir Osmangazi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- being 18 years or older
- having COVID-19 treatment (home quarantine/hospital/intensive care unit) according to a positive polymerase chain reaction (PCR) test in a nasopharyngeal + oropharyngeal swab or chest computed tomography (CT)
- participating in a home-based exercise program (for 6 weeks) or hospital-based CPR (for 12-20 sessions) due to post-acute COVID-19 symptoms (fatigue, myalgia, dyspnea).
Exclusion Criteria:
- Patients who had both a negative PCR test and chest CT
- Patients who had not completed the six minute walk test (6MWT), Borg scales, Short Form-36 and Visual analog scale-pain.
- Acute COVID-19 patients (patients whose symptoms had started less than one month previous)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home based cardiopulmonary rehabilitation group
This was a retrospective study.
43 patients who had home based cardiopulmonary rehabilitation programme between January and July 2023, in our rehabilitation clinic.
|
Both protocols consisted of aerobic, breathing and flexibility exercises.
Hospital-based CPR: three or four days per week for a total of 20 sessions.
Home-based CPR: three or four days/a week over a period of six weeks.
|
|
Experimental: Hospital based cardiopulmonary rehabilitation group
This was a retrospective study.
45 patients who had hospital based cardiopulmonary rehabilitation programme between January and July 2023, in our rehabilitation clinic.
|
Both protocols consisted of aerobic, breathing and flexibility exercises.
Hospital-based CPR: three or four days per week for a total of 20 sessions.
Home-based CPR: three or four days/a week over a period of six weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise endurance
Time Frame: One day before exercise programme start and one day later exercise programme ends
|
Six minutes walk test (All patients walked along a 30-meter-long corridor without obstacles at their normal walking speed, how many meters they walked was noted.)
|
One day before exercise programme start and one day later exercise programme ends
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea
Time Frame: One day before exercise programme start and one day later exercise programme ends
|
Borg scale were also measured before and after 6MWT for perceived dyspnea (scale range from 0 to 10)
|
One day before exercise programme start and one day later exercise programme ends
|
|
Muscle fatigue
Time Frame: One day before exercise programme start and one day later exercise programme ends
|
Borg muscle fatigue (scale range from 6 to 20: higher values show more severe symptoms)
|
One day before exercise programme start and one day later exercise programme ends
|
|
short form 36
Time Frame: One day before exercise programme start and one day later exercise programme ends
|
A quality-of-life assessment was performed using the Short Form-36, which has 36 items regarding physical function, physical role, emotional role, energy, body pain, mental health, general health, and social function.
The scale ranges from 0 (poor health) to 100 (perfect health)
|
One day before exercise programme start and one day later exercise programme ends
|
|
Musculoskeletal Pain
Time Frame: One day before exercise programme start and one day later exercise programme ends
|
Visual analog scale-pain was used to measure general body musculoskeletal pain, which was assessed from 0 (no pain) to 10 (worst possible pain)
|
One day before exercise programme start and one day later exercise programme ends
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fulya Bakılan, Assoc. Prof., Eskisehir Osmangazi University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CardioPulmonaryRehab
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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