Corona Virus InfectionNCT04836767
Evaluation of Physical and Functional Status in Patients With COVID-19 in Long Term
An observational study of Corona Virus Infection and Covid19, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The reason the investigators want to do this research; Especially after Covid-19 infection, no research has been found on functional status in the long term. Therefore, in our study, the investigators aimed to evaluate exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection, Covid19
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2021to 3 Feb 2022
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population of the study is individuals who live in Ankara and have passed the diagnosis of COVID-19 for at least 12 weeks and healthy individuals who have not had COVID-19. The sample of the study is healthy individuals in the long term after the diagnosis of COVID-19 at least 12 weeks after the diagnosis of COVID-19 and healthy individuals who have not had COVID-19 in Hacettepe University Adult Hospital who meet the inclusion criteria and volunteer to participate in the study.
COVID-19 Group Inclusion Criteria
- Having been diagnosed with COVID-19 at least 12 weeks ago,
- Being literate,
- Being in the age range of 18-65,
- Volunteering to participate in research,
- To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
- Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity.
COVID-19 Group Exclusion Criteria Those with an ICU hospitalization history due to the diagnosis of COVID-19,
- Recent myocardial infarction and pulmonary embolism.
- Having accompanying chronic diseases,
- Those who have any orthopedic or neurological disorders that will prevent walking,
- Another COVID-19 PCR Test positivity in the last 12 weeks,
- Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders, Healthy Group Inclusion Criteria
- Not having COVID-19,
- Being literate,
- Being in the age range of 18-65,
- Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study
- Those who have any orthopedic or neuromuscular disorders that will prevent walking,
- Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Exercise Capacity, Peripheral Muscle Strength, Balance, Cognitive Status and Quality of Life in Patients With COVID-19 in Long Term
The reason the investigators want to do this research; Especially after Covid-19 infection, no research has been found on functional status in the long term. Therefore, in our study, the investigators aimed to evaluate exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, consciousness, work productivity, pain, fear of movement, and quality of life in patients with Covid-19 and to compare them with healthy individuals who have not had COVID-19.
Read the detailed description
In our study, the investigators aimed to evaluate long-term exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, cognitive status, pain, kinesophobia and quality of life in patients with COVID-19, and to compare them with healthy individuals who have not had COVID-19. Our second goal; It is the evaluation of the relationship between long-term exercise capacity, pain, kinesiophobia, peripheral muscle strength, balance, anxiety and depression level, cognitive status and quality of life in individuals with COVID-19. It will also be examined whether these parameters change according to the post-COVID functional restriction level.
- Materials and Methods of the Research: 3.1. The place of the study: Cardiopulmonary Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation and Hacettepe University Faculty of Medicine Department of General Internal Medicine
3.2. Time of the study: It is planned to collect data and write the study between February 2021 and February 2022.
3.3. Research population, sample, research group:
The population of the study is individuals who have passed the diagnosis of COVID-19 for at least 12 weeks and healthy individuals who have not had COVID-19.
The sample of the study is individuals in the long-term after the diagnosis of COVID-19 at least 12 weeks after the diagnosis of COVID-19 in Hacettepe University Adult Hospital who meet the inclusion criteria and volunteer to participate in the study, and healthy individuals who have not had COVID-19.
Study Design:
Individuals meeting the inclusion criteria will be included in the study. The study will be conducted with people between the ages of 18-65, whose education level is at least primary school, and whose local language is Turkish. A total of 40 participants, 20 healthy without COVID-19, and 20 with at least 12 weeks past the diagnosis of COVID-19, will be included in the study. The guidance of the participants will be provided by the relevant physicians of the General Internal Medicine Unit of Hacettepe University Internal Diseases Department.
In accordance with the COVID-19 pandemic precautions, social distance rules will be followed in the tests to be carried out with individuals, care will be taken to use masks, and the materials to be used in tests and measurements will be disinfected before and after use.
COVID-19 Group Inclusion Criteria
- Having been diagnosed with COVID-19 at least 12 weeks ago,
- Being literate,
- Being in the age range of 18-65,
- Volunteering to participate in research,
- To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
- Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity.
COVID-19 Group Exclusion Criteria
- Those with an ICU hospitalization history due to the diagnosis of COVID-19,
- Recent myocardial infarction and pulmonary embolism.
- Having accompanying chronic diseases,
- Those who have any orthopedic or neurological disorders that will prevent walking,
- Another COVID-19 PCR Test positivity in the last 12 weeks,
- Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders,
Healthy Group Inclusion Criteria
- Not having COVID-19,
- Being literate,
- Being in the age range of 18-65,
- Volunteering to participate in research.
The Criteria for Not Including the Healthy Group in the Study
- Those who have any orthopedic or neuromuscular disorders that will prevent walking,
- Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests.
Individuals participating in the study will be informed verbally and in writing about the study protocol and informed consent form will be obtained.
- Conditions
- Corona Virus Infection, Covid19
- Keywords
- COVID-19, SARS-CoV2, pandemic, post-COVID-19, exercise capacity
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| people with a history of COVID-19 | COVID-19 Group Inclusion Criteria * Having been diagnosed with COVID-19 at least 12 weeks ago, * Being literate, * Being in the age range of 18-65, * Volunteering to participate in research, * To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes), * Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity. COVID-19 Group Exclusion Criteria * Those with an ICU hospitalization history due to the diagnosis of COVID-19, * Recent myocardial infarction and pulmonary embolism. * Having accompanying chronic diseases, * Those who have any orthopedic or neurological disorders that will prevent walking, * Another COVID-19 PCR Test positivity in the last 12 weeks, * Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders, | |
| healthy people | Healthy Group Inclusion Criteria * Not having COVID-19, * Being literate, * Being in the age range of 18-65, * Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study * Those who have any orthopedic or neuromuscular disorders that will prevent walking, * Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental shuttle walking test
It assesses maximal exercise capacity.
Measured: January,2021 - December,2021
Secondary outcomes (9)
Time up and Go Test
Functional balance and walking capacity
Measured: January,2021 - December,2021
Short form McGill-Melzack Pain Questionnaire
The pain rating index has 2 subscales:
Sensory subscale with 11 words, and Affective subscale with 4 words. These words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity and one item for a 10 cm visual analogue scale (VAS) for average pain.
The higher the total score on the MPQ, the more the pain experience for the patient increases
Measured: January,2021 - December,2021
Tampa Kinesophobia Questionnaire
Assessment of fear of movement. Scores range from 17-68. Higher scores indicate higher level of kinesiophobia
Measured: January,2021 - December,2021
Hospital Anxiety and Depression Scale
Assessment of anxiety and depression. Scores range from 0 to 21 for each of the two subscales. Higher scores indicate higher level of anxiety and depression
Measured: January,2021 - December,2021
SF-36 Quality of Life Scale
Assessment of life quality. The scores of each domain ranges from zero to 100 which higher scores indicating higher levels of functioning or well-being
Measured: January,2021 - December,2021
Fatigue Severity Scale
Assessment of fatigue perception. Scores range from 0-7. Scores higher than 4 indicate severe fatigue perception.
Measured: January,2021 - December,2021
Cognitive Status Scale
Assessment of cognitive status. Score ranges from 0-100. Higher scores indicate increased tendency to cognitive failure.
Measured: January,2021 - December,2021
Body Mass Index
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Measured: January,2021 - December,2021
Body composition analysis with bioelectrical impedance analysis system
FM and FFM ratio
Measured: January,2021 - December,2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start16 Feb 2021
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- Gülay Sain-Guven, Professor, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836767
- Sponsor's protocol ID
- GO21-178
- Status last verified
- Aug 2022
- First submitted
- 7 Apr 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.
PubMed 32475821Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
PubMed 32085846Zhao H, Shen D, Zhou H, Liu J, Chen S. Guillain-Barre syndrome associated with SARS-CoV-2 infection: causality or coincidence? Lancet Neurol. 2020 May;19(5):383-384. doi: 10.1016/S1474-4422(20)30109-5. Epub 2020 Apr 1. No abstract available.
PubMed 32246917Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
PubMed 32064853Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patients who survived hospitalisation. Eur Respir J. 2020 Oct 15;56(4):2002096. doi: 10.1183/13993003.02096-2020. Print 2020 Oct.
PubMed 32764112
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Exercise Capacity, Peripheral Muscle Strength, Balance, Cognitive Status and Quality of Life in Patients With COVID-19 in Long Term
- ClinicalTrials.gov ID
- NCT04836767
- Acronym / sponsor ID
- GO21-178
- Conditions
- Corona Virus Infection, Covid19
- Keywords
- COVID-19, SARS-CoV2, pandemic, post-COVID-19, exercise capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 8 Apr 2021 (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 reason the investigators want to do this research; Especially after Covid-19 infection, no research has been found on functional status in the long term. Therefore, in our study, the investigators aimed to evaluate exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, consciousness, work productivity, pain, fear of movement, and quality of life in patients with Covid-19 and to compare them with healthy individuals who have not had COVID-19.
Detailed description
In our study, the investigators aimed to evaluate long-term exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, cognitive status, pain, kinesophobia and quality of life in patients with COVID-19, and to compare them with healthy individuals who have not had COVID-19. Our second goal; It is the evaluation of the relationship between long-term exercise capacity, pain, kinesiophobia, peripheral muscle strength, balance, anxiety and depression level, cognitive status and quality of life in individuals with COVID-19. It will also be examined whether these parameters change according to the post-COVID functional restriction level.
- Materials and Methods of the Research: 3.1. The place of the study: Cardiopulmonary Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation and Hacettepe University Faculty of Medicine Department of General Internal Medicine
3.2. Time of the study: It is planned to collect data and write the study between February 2021 and February 2022.
3.3. Research population, sample, research group:
The population of the study is individuals who have passed the diagnosis of COVID-19 for at least 12 weeks and healthy individuals who have not had COVID-19.
The sample of the study is individuals in the long-term after the diagnosis of COVID-19 at least 12 weeks after the diagnosis of COVID-19 in Hacettepe University Adult Hospital who meet the inclusion criteria and volunteer to participate in the study, and healthy individuals who have not had COVID-19.
Study Design:
Individuals meeting the inclusion criteria will be included in the study. The study will be conducted with people between the ages of 18-65, whose education level is at least primary school, and whose local language is Turkish. A total of 40 participants, 20 healthy without COVID-19, and 20 with at least 12 weeks past the diagnosis of COVID-19, will be included in the study. The guidance of the participants will be provided by the relevant physicians of the General Internal Medicine Unit of Hacettepe University Internal Diseases Department.
In accordance with the COVID-19 pandemic precautions, social distance rules will be followed in the tests to be carried out with individuals, care will be taken to use masks, and the materials to be used in tests and measurements will be disinfected before and after use.
COVID-19 Group Inclusion Criteria
- Having been diagnosed with COVID-19 at least 12 weeks ago,
- Being literate,
- Being in the age range of 18-65,
- Volunteering to participate in research,
- To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
- Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity.
COVID-19 Group Exclusion Criteria
- Those with an ICU hospitalization history due to the diagnosis of COVID-19,
- Recent myocardial infarction and pulmonary embolism.
- Having accompanying chronic diseases,
- Those who have any orthopedic or neurological disorders that will prevent walking,
- Another COVID-19 PCR Test positivity in the last 12 weeks,
- Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders,
Healthy Group Inclusion Criteria
- Not having COVID-19,
- Being literate,
- Being in the age range of 18-65,
- Volunteering to participate in research.
The Criteria for Not Including the Healthy Group in the Study
- Those who have any orthopedic or neuromuscular disorders that will prevent walking,
- Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests.
Individuals participating in the study will be informed verbally and in writing about the study protocol and informed consent form will be obtained.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| people with a history of COVID-19 | – | –COVID-19 Group Inclusion Criteria * Having been diagnosed with COVID-19 at least 12 weeks ago, * Being literate, * Being in the age range of 18-65, * Volunteering to participate in research, * To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes), * Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity. COVID-19 Group Exclusion Criteria * Those with an ICU hospitalization history due to the diagnosis of COVID-19, * Recent myocardial infarction and pulmonary embolism. * Having accompanying chronic diseases, * Those who have any orthopedic or neurological disorders that will prevent walking, * Another COVID-19 PCR Test positivity in the last 12 weeks, * Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders, |
| healthy people | – | –Healthy Group Inclusion Criteria * Not having COVID-19, * Being literate, * Being in the age range of 18-65, * Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study * Those who have any orthopedic or neuromuscular disorders that will prevent walking, * Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study is individuals who live in Ankara and have passed the diagnosis of COVID-19 for at least 12 weeks and healthy individuals who have not had COVID-19. The sample of the study is healthy individuals in the long term after the diagnosis of COVID-19 at least 12 weeks after the diagnosis of COVID-19 and healthy individuals who have not had COVID-19 in Hacettepe University Adult Hospital who meet the inclusion criteria and volunteer to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incremental shuttle walking test
Time frame: January,2021 - December,2021
It assesses maximal exercise capacity.
9 secondary outcomes
Time up and Go Test
Time frame: January,2021 - December,2021
Short form McGill-Melzack Pain Questionnaire
Time frame: January,2021 - December,2021
Tampa Kinesophobia Questionnaire
Time frame: January,2021 - December,2021
Hospital Anxiety and Depression Scale
Time frame: January,2021 - December,2021
SF-36 Quality of Life Scale
Time frame: January,2021 - December,2021
Fatigue Severity Scale
Time frame: January,2021 - December,2021
Cognitive Status Scale
Time frame: January,2021 - December,2021
Body Mass Index
Time frame: January,2021 - December,2021
Body composition analysis with bioelectrical impedance analysis system
Time frame: January,2021 - December,2021
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 9 Aug 2022.
- Results publication: PubMed 32475821Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.
- Results publication: PubMed 32085846Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
- Results publication: PubMed 32246917Zhao H, Shen D, Zhou H, Liu J, Chen S. Guillain-Barre syndrome associated with SARS-CoV-2 infection: causality or coincidence? Lancet Neurol. 2020 May;19(5):383-384. doi: 10.1016/S1474-4422(20)30109-5. Epub 2020 Apr 1. No abstract available.
- Results publication: PubMed 32064853Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
- Results publication: PubMed 32764112Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patients who survived hospitalisation. Eur Respir J. 2020 Oct 15;56(4):2002096. doi: 10.1183/13993003.02096-2020. Print 2020 Oct.
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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.
Gülay Sain-Guven, Professor study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corona Virus Infection and Covid19, run by Hacettepe 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?
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 9 Aug 2022. 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?
Incremental shuttle walking test (time frame: January,2021 - December,2021). 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 NCT04836767, which also lists 5 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 9 Aug 2022.