CardiopulmonaryNCT05787353
Cardiopulmonary Rehabilitation for Post-acute COVID-19 Symptoms
A study testing Exercise programme in people with Cardiopulmonary, run by Eskisehir City Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary
- What is being tested?
- Exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2021to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University
Eskişehir, Odunpazarı
About this study
Official title: 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.
- Conditions
- Cardiopulmonary
- Being tested
- Exercise programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programmeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home based cardiopulmonary rehabilitation group | Experimental | This was a retrospective study. 43 patients who had home based cardiopulmonary rehabilitation programme between January and July 2023, in our rehabilitation clinic. Receives: Other: Exercise programme |
| Hospital based cardiopulmonary rehabilitation group | Experimental | This was a retrospective study. 45 patients who had hospital based cardiopulmonary rehabilitation programme between January and July 2023, in our rehabilitation clinic. Receives: Other: Exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: One day before exercise programme start and one day later exercise programme ends
Secondary outcomes (4)
Dyspnea
Borg scale were also measured before and after 6MWT for perceived dyspnea (scale range from 0 to 10)
Measured: One day before exercise programme start and one day later exercise programme ends
Muscle fatigue
Borg muscle fatigue (scale range from 6 to 20: higher values show more severe symptoms)
Measured: One day before exercise programme start and one day later exercise programme ends
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)
Measured: One day before exercise programme start and one day later exercise programme ends
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)
Measured: One day before exercise programme start and one day later exercise programme ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start16 Apr 2021
- Primary completion25 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiopulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Bakılan, Eskisehir City Hospital
- Investigators
- Fulya Bakılan, Assoc. Prof., Principal investigator, Eskişehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787353
- Sponsor's protocol ID
- CardioPulmonaryRehab
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital- Versus Home-based Cardiopulmonary Rehabilitation for Post-acute COVID-19 Symptoms
- ClinicalTrials.gov ID
- NCT05787353
- Acronym / sponsor ID
- CardioPulmonaryRehab
- Conditions
- Cardiopulmonary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Eskisehir City HospitalUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 25 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home based cardiopulmonary rehabilitation group | Experimental | Other: Exercise programmeThis was a retrospective study. 43 patients who had home based cardiopulmonary rehabilitation programme between January and July 2023, in our rehabilitation clinic. |
| Hospital based cardiopulmonary rehabilitation group | Experimental | Other: Exercise programmeThis was a retrospective study. 45 patients who had hospital based cardiopulmonary rehabilitation programme between January and July 2023, in our rehabilitation clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programmeBoth 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. | Other | Home based cardiopulmonary rehabilitation group, Hospital based cardiopulmonary rehabilitation group |
Primary outcome
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.)
4 secondary outcomes
Dyspnea
Time frame: 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
short form 36
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Cardiopulmonary
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
Chronic Obstructive Pulmonary Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fulya Bakılan, Assoc. Prof. principal investigator
Eskişehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise programme in people with Cardiopulmonary, run by Eskisehir City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise endurance (time frame: One day before exercise programme start and one day later exercise programme ends). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.