Quality of LifeNCT06568393
Effectiveness of Calisthenic Exercises in Post-Covid Syndrome
A study testing Calisthenic exercise in people with Quality of Life, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Post-Covid syndrome is known as the appearance of some symptoms for 12 weeks or more after Covid-19 infection, affecting the patient's quality of life. The wide range of symptoms that occur after post-Covid syndrome has led to the development of different interventions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- Calisthenic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 15 Apr 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be 18 years of age or older, previous having Covid-19 infection, 12 weeks or more of post-covid symptoms.
Who cannot join
- The presence of acute viral or bacterial infection, having been previously diagnosed with a rheumatic, neurological, metabolic or oncological disease, having undergone any surgical procedure after musculoskeletal injury, use of intra-articular prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Calisthenic Exercises on Quality of Life in Post-Covid Syndrome: A Randomized Controlled Trial
Post-Covid syndrome is known as the appearance of some symptoms for 12 weeks or more after Covid-19 infection, affecting the patient's quality of life. The wide range of symptoms that occur after post-Covid syndrome has led to the development of different interventions. In this study, we tried to measure changes in quality of life in people with post-covid syndrome as a result of using calisthenics with therapists and home exercise. Quality of life scale scores were compared before and after an 8-weeks exercise intervention.
Read the detailed description
In this study, a quantitative approach with a pre-test-post-test design was applied to compare the effect of calisthenic exercises on quality of life in individuals with post-covid syndrome in the form of a therapist-guided and home exercise programme. Participants signed an informed consent form before inclusion in the study and the details of the study were clearly explained. At baseline, age, gender, height, weight, symptoms and duration of symptoms were recorded. Quality of life data were recorded with the EQ-5D-3L questionnaire at baseline and 8 weeks after the exercise intervention.
- Conditions
- Quality of Life
- Being tested
- Calisthenic exercise
- Keywords
- Post-COVID Condition, Long COVID, Life Quality, Exercise Training
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calisthenic exerciseOther
Calisthenic exercise program was included: jumping jack, burpee, mountain climber, squat thrust, squat, squat jump, split and alternate exercises.
| Study group | Role | What they receive |
|---|---|---|
| Calisthenic | Experimental | In this group, calisthenic exercises were performed by a therapist with face to face and it was taken for 8 weeks. Receives: Other: Calisthenic exercise |
| Home exercise | Active comparator | In this group, a home exercise programme of calisthenic exercises was prepared and shown to the participants with visuals and they were asked to perform this exercise programme for 8 weeks. Receives: Other: Calisthenic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version)
Depending on the answers given in this questionnaire, 1 - 3 points are assigned, while a low score indicates a healthy state, a high score indicates a problem that reduces the quality of life. In the second part of the questionnaire, there is a part where a score between 0-100 is asked to explain the state of being healthy today, in this part, low scores indicate that there are health problems and high scores define the state of being healthy.
Measured: Baseline of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Nov 2023
- Primary completion1 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Model description
- The study was conducted in 2 groups, one intervention and one control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Percin, Bahçeşehir University
- Investigators
- Alper Percin, Asst. Prof., Principal investigator, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568393
- Sponsor's protocol ID
- AP0007
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Domaszewska K, Boraczynski M, Tang YY, Gronek J, Wochna K, Boraczynski T, Wielinski D, Gronek P. Protective Effects of Exercise Become Especially Important for the Aging Immune System in The Covid-19 Era. Aging Dis. 2022 Feb 1;13(1):129-143. doi: 10.14336/AD.2021.1219. eCollection 2022 Feb.
PubMed 35111366Muniswamy P, Gorhe V, Parashivakumar L, Chandrasekaran B. Short-term effects of a social media-based intervention on the physical and mental health of remotely working young software professionals: A randomised controlled trial. Appl Psychol Health Well Being. 2022 May;14(2):537-554. doi: 10.1111/aphw.12318. Epub 2021 Nov 8.
PubMed 34750975Tekin F, Cetisli-Korkmaz N. Effectiveness of a Telerehabilitative Home Exercise Program on Elder Adults' Physical Performance, Depression and Fear of Falling. Percept Mot Skills. 2022 Jun;129(3):714-730. doi: 10.1177/00315125221087026. Epub 2022 Apr 11.
PubMed 35404709
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Calisthenic Exercises on Quality of Life in Post-Covid Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06568393
- Acronym / sponsor ID
- AP0007
- Conditions
- Quality of Life
- Keywords
- Post-COVID Condition, Long COVID, Life Quality, Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 23 Aug 2024 (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.
Post-Covid syndrome is known as the appearance of some symptoms for 12 weeks or more after Covid-19 infection, affecting the patient's quality of life. The wide range of symptoms that occur after post-Covid syndrome has led to the development of different interventions. In this study, we tried to measure changes in quality of life in people with post-covid syndrome as a result of using calisthenics with therapists and home exercise. Quality of life scale scores were compared before and after an 8-weeks exercise intervention.
Detailed description
In this study, a quantitative approach with a pre-test-post-test design was applied to compare the effect of calisthenic exercises on quality of life in individuals with post-covid syndrome in the form of a therapist-guided and home exercise programme. Participants signed an informed consent form before inclusion in the study and the details of the study were clearly explained. At baseline, age, gender, height, weight, symptoms and duration of symptoms were recorded. Quality of life data were recorded with the EQ-5D-3L questionnaire at baseline and 8 weeks after the exercise intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study was conducted in 2 groups, one intervention and one control group.
| Arm | Type | Receives |
|---|---|---|
| Calisthenic | Experimental | Other: Calisthenic exerciseIn this group, calisthenic exercises were performed by a therapist with face to face and it was taken for 8 weeks. |
| Home exercise | Active comparator | Other: Calisthenic exerciseIn this group, a home exercise programme of calisthenic exercises was prepared and shown to the participants with visuals and they were asked to perform this exercise programme for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be 18 years of age or older, previous having Covid-19 infection, 12 weeks or more of post-covid symptoms.
Key exclusion criteria (1 listed)
- The presence of acute viral or bacterial infection, having been previously diagnosed with a rheumatic, neurological, metabolic or oncological disease, having undergone any surgical procedure after musculoskeletal injury, use of intra-articular prosthesis
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 |
|---|---|---|
| Calisthenic exerciseCalisthenic exercise program was included: jumping jack, burpee, mountain climber, squat thrust, squat, squat jump, split and alternate exercises. | Other | Calisthenic, Home exercise |
Primary outcome
EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version)
Time frame: Baseline of the study
Depending on the answers given in this questionnaire, 1 - 3 points are assigned, while a low score indicates a healthy state, a high score indicates a problem that reduces the quality of life. In the second part of the questionnaire, there is a part where a score between 0-100 is asked to explain the state of being healthy today, in this part, low scores indicate that there are health problems and high scores define the state of being healthy.
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 26 Aug 2024.
- Background: PubMed 35111366Domaszewska K, Boraczynski M, Tang YY, Gronek J, Wochna K, Boraczynski T, Wielinski D, Gronek P. Protective Effects of Exercise Become Especially Important for the Aging Immune System in The Covid-19 Era. Aging Dis. 2022 Feb 1;13(1):129-143. doi: 10.14336/AD.2021.1219. eCollection 2022 Feb.
- Background: PubMed 34750975Muniswamy P, Gorhe V, Parashivakumar L, Chandrasekaran B. Short-term effects of a social media-based intervention on the physical and mental health of remotely working young software professionals: A randomised controlled trial. Appl Psychol Health Well Being. 2022 May;14(2):537-554. doi: 10.1111/aphw.12318. Epub 2021 Nov 8.
- Background: PubMed 35404709Tekin F, Cetisli-Korkmaz N. Effectiveness of a Telerehabilitative Home Exercise Program on Elder Adults' Physical Performance, Depression and Fear of Falling. Percept Mot Skills. 2022 Jun;129(3):714-730. doi: 10.1177/00315125221087026. Epub 2022 Apr 11.
- Individual participant dataSharing planned: No
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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.
Alper Percin, Asst. Prof. principal investigator
Bahçeşehir 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 Calisthenic exercise in people with Quality of Life, run by Bahçeşehir University 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 26 Aug 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?
EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) (time frame: Baseline of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06568393, which also lists 3 linked publications.
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 26 Aug 2024.