COVID-19 PneumoniaNCT05739032
Exercise Training Six-Months After Discharge in Post-COVID-19 Syndrome
A study testing Aerobic exercise and strength training in people with COVID-19 Pneumonia, run by Ukbe Sirayder at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study investigate the effects of 12-week exercise training on pulmonary function, symptoms, functional capacity, and quality of life (QoL) in patients with severe COVID 6 months after intensive care discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Aerobic exercise and strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2021to 30 Oct 2022
- 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
- COVID-19 pneumonia patients were followed up for at least 24 h in the ICU. Those post-COVID six months who could cooperate with the tests and volunteered to participate were included.
Who cannot join
- Individuals with pulmonary, orthopedic, neurological, vestibular, and psychological problems diagnosed before COVID-19 infection; myocarditis developed after COVID-19 infection; and those pregnant and those having any other acute diseases (such as infection and trauma) that would prevent performing the tests and/or interfering with the test results were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Training Six-Months After Discharge in Post-COVID-19 Syndrome: Randomized Controlled Trial
The goal of this study investigate the effects of 12-week exercise training on pulmonary function, symptoms, functional capacity, and quality of life (QoL) in patients with severe COVID 6 months after intensive care discharge. The main question it aims to answer are:
1-Does exercise training given in post-COVID-19 syndrome have an effect on pulmonary function, symptoms, functional capacity, muscle strength and quality of life?
25 severe post-COVID patients (35 M) were in exercise group (EG) (age=52.9±11 years, 18M), and 25 (age=53.6±11.9 years, 17M) were in the control group (CG). EG received aerobic exercise (30-min walking) and upper and lower extremity strength training for 12 weeks for 3 days/week. CG continued only routine follow-up.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Aerobic exercise and strength training
- Keywords
- post-COVID-19, Lung function, Fatigue, Aerobic exercise, Strength training
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise and strength trainingOther
Aerobic Exercise Training: The individuals in the study group were given aerobic exercise training at 70-80% of the 6MWT average speed. Patients performed exercise three days per week (twice under the supervision of a physiotherapist and once at home) for 30 minutes a day.
Strength Training: Lower and upper extremity strengthening training was performed three days a week, 3x10-12 repetitions per day, with the help of a resistance band suitable for muscle strength. Hip flexion, hip abduction, knee flexion, and knee extension exercises for the lower extremity, and shoulder flexion, shoulder extension, shoulder abduction, shoulder elevation, external rotation, horizontal shoulder abduction, and scapular adduction exercises for the upper extremity were performed.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Exercise group received aerobic exercise (30-min walking) and upper and lower extremity strength training for 12 weeks for 3 days/week. Receives: Other: Aerobic exercise and strength training |
| Control group | No intervention | Control group continued only routine follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Minute Walk Test Distance
Measured: six minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start5 Mar 2021
- Primary completion30 May 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ukbe Sirayder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ukbe Sirayder, Nuh Naci Yazgan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739032
- Sponsor's protocol ID
- NNYUSİRAYDER1
- Status last verified
- Jan 2024
- First submitted
- 21 Feb 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: send via mail
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training Six-Months After Discharge in Post-COVID-19 Syndrome: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05739032
- Acronym / sponsor ID
- NNYUSİRAYDER1
- Conditions
- COVID-19 Pneumonia
- Keywords
- post-COVID-19, Lung function, Fatigue, Aerobic exercise, Strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ukbe SirayderUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 22 Feb 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 goal of this study investigate the effects of 12-week exercise training on pulmonary function, symptoms, functional capacity, and quality of life (QoL) in patients with severe COVID 6 months after intensive care discharge. The main question it aims to answer are:
1-Does exercise training given in post-COVID-19 syndrome have an effect on pulmonary function, symptoms, functional capacity, muscle strength and quality of life?
25 severe post-COVID patients (35 M) were in exercise group (EG) (age=52.9±11 years, 18M), and 25 (age=53.6±11.9 years, 17M) were in the control group (CG). EG received aerobic exercise (30-min walking) and upper and lower extremity strength training for 12 weeks for 3 days/week. CG continued only routine follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Aerobic exercise and strength trainingExercise group received aerobic exercise (30-min walking) and upper and lower extremity strength training for 12 weeks for 3 days/week. |
| Control group | No intervention | –Control group continued only routine follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COVID-19 pneumonia patients were followed up for at least 24 h in the ICU. Those post-COVID six months who could cooperate with the tests and volunteered to participate were included.
Key exclusion criteria (1 listed)
- Individuals with pulmonary, orthopedic, neurological, vestibular, and psychological problems diagnosed before COVID-19 infection; myocarditis developed after COVID-19 infection; and those pregnant and those having any other acute diseases (such as infection and trauma) that would prevent performing the tests and/or interfering with the test results were excluded.
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 |
|---|---|---|
| Aerobic exercise and strength trainingAerobic Exercise Training: The individuals in the study group were given aerobic exercise training at 70-80% of the 6MWT average speed. Patients performed exercise three days per week (twice under the supervision of a physiotherapist and once at home) for 30 minutes a day. Strength Training: Lower and upper extremity strengthening training was performed three days a week, 3x10-12 repetitions per day, with the help of a resistance band suitable for muscle strength. Hip flexion, hip abduction, knee flexion, and knee extension exercises for the lower extremity, and shoulder flexion, shoulder extension, shoulder abduction, shoulder elevation, external rotation, horizontal shoulder abduction, and scapular adduction exercises for the upper extremity were performed. | Other | Exercise group |
Primary outcome
Six Minute Walk Test Distance
Time frame: six minute
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 16 Jan 2024.
- Individual participant dataSharing planned: Yes. send via mail
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and strength training in people with COVID-19 Pneumonia, run by Ukbe Sirayder 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 1 inclusion and 1 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 16 Jan 2024. 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?
Six Minute Walk Test Distance (time frame: six minute). 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 16 Jan 2024.