Cardiopulmonary Rehabilitation for Post-acute COVID-19 Symptoms

• Sponsor: Eskisehir City Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05787353
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 25.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiopulmonary	Other: Exercise programme	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hospital- Versus Home-based Cardiopulmonary Rehabilitation for Post-acute COVID-19 Symptoms
• Actual Study Start Date: Apr 16, 2021
• Actual Primary Completion Date: Jul 25, 2021
• Actual Study Completion Date: Jul 31, 2021

Arms and Interventions

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.	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.
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.	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.

Outcome Measures

Primary Outcome Measures

1. Exercise endurance [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.)

Secondary Outcome Measures

1. Dyspnea [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)

2. Muscle fatigue [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)

3. short form 36 [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)

4. Musculoskeletal Pain [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eskişehir Osmangazi University	Eskişehir	Odunpazarı	Turkey

Sponsors and Collaborators

• Eskisehir City Hospital

Investigators

• Principal Investigator: Fulya Bakılan, Assoc. Prof., Eskişehir Osmangazi University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fulya Bakılan, Principal Investigator, Eskisehir City Hospital
• ClinicalTrials.gov Identifier: NCT05787353
• Other Study ID Numbers: CardioPulmonaryRehab
• First Posted: Mar 28, 2023
• Last Update Posted: Mar 30, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 30, 2023