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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05787353
Other study ID # CardioPulmonaryRehab
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 16, 2021
Est. completion date July 31, 2021

Study information

Verified date March 2023
Source Eskisehir City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date July 31, 2021
Est. primary completion date July 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise programme
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.

Locations

Country Name City State
Turkey Eskisehir Osmangazi University Eskisehir Odunpazari

Sponsors (1)

Lead Sponsor Collaborator
Eskisehir City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exercise endurance 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 Dyspnea 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
Secondary Muscle fatigue 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
Secondary short form 36 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
Secondary Musculoskeletal Pain 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
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