Covid19NCT04834739
Comparison of Functional Capacities of Healthcare Workers With and Without Covid-19
A study testing 6 minute walk test, 1 minute Sit to Stand Test and Fatigue Severity Scale in people with Covid19 and Functional Capacity, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate if the functional capacity of health workers sustained covid 19 infection effects functional capacity , quality of life and mood of health workers when comparing healthy health workers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Functional Capacity
- What is being tested?
- 6 minute walk test, 1 minute Sit to Stand Test and Fatigue Severity Scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2021to 30 Apr 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a health worker over the age of 18 (for both control group)
- Having had SARS-CoV-2 (Covid 19) disease in the last 1 month and completed the isolation process
- Volunteer to participate in the study, being discharged from the hospital and completing the isolation process at home (The first assessment will be made within the 1st month after the patient's Covid 19 positivity is detected; control will be made three times in the 2nd, 4th and 6th months)
- Being able to walk or sit and stand without any help
- Speaking and understand the Turkish language.
Who cannot join
- Neurological or musculoskeletal disease that causes gait impairment
- Cognitive impairment
- Having unstable cardiac, respiratory and metabolic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul
About this study
This study aimed to investigate if the functional capacity of health workers sustained covid 19 infection effects functional capacity , quality of life and mood of health workers when comparing healthy health workers.
Read the detailed description
This study was designed in Physical Medicine and Rehabilitation Service of Gaziosmanpasa Training and Research Hospital between January 4 and June 30, 2021.Data of the health workers from our hospital who suffered from Covid-19 disease and matched control group who had not have Covid-19 disease participants were analyzed. Participants signed a general consent .Inclusion criteria; being a health worker over the age of 18 (for both groups), having had SARS-CoV-2 (Covid 19) disease for last 1 month and completed the isolation process, volunteer to participate in the study, , being able to walk or sit and stand without any help, speaking and understand Turkish language. Exclusion criteria (for both study and control group); Neurological or musculoskeletal disease that causes gait impairment, cognitive impairment, having unstable cardiac, respiratory and metabolic disease.(The first assessment will be made within the 1st month after the patient's Covid 19 positivity is detected; control will be made three times in the 2nd, 4th and 6 months)
30 volunteer healthcare workers who had Covid-19 were included to study group. 30 age and gender matched volunteer healthcare workers were included to control group. Healthcare workers who have had Covid-19 disease will be evaluated for the first time within 1 month after their diagnosis with RT-PCR test for SARS-CoV-2.
Symptom questioning will be reported including the initial symptoms of Covid-19 and ongoing complaints of the patients. During the examination, muscle strength will be evaluated by the Medical Research Council (MRC) total score. Resting heart rate, blood pressure and oxygen saturation (by pulse oxymeter) measurement will be applied to both groups before and after the following tests: 1-min sit-to-stand (1MSTS) test, 5 times sit-to-stand (5TSTS) test, 6 minutes walk test (6MWT).
MRC dyspnea scale will be performed as a measure of patient's complaint of shortness of breath,Job performance was assessed by asking "How do you evaluate your job performance?" on 6-point Likert scale, Short Form-12 (Short Form 12, SF-12) will be used to assess quality of life, mood disorder wil be measured by Beck Anxiety Inventory and Beck Depression Inventory, Fatigue severity scale(FSS) will be performed as level of fatigue. The first evaluation wil be made within 1 month after one positive RT-PCR test for SARS-CoV-2 is detected; control evaluations will be made in the 2nd, 4th and 6th months after positivity of RT-PCR test for SARS-CoV-2. Finally, the patient's sex, age, body mass index (BMI), height, education status, career, status of hospitalization, length of hospitalization, comorbidities , pulmonary involvement that diagnosed radiological methods and examination of symptoms related with Covid-19 will be recorded.
- Conditions
- Covid19, Functional Capacity
- Being tested
- 6 minute walk test, 1 minute Sit to Stand Test, Fatigue Severity Scale, Medical Research Council (MRC) dyspnea scale, SF-12
- Keywords
- Covid-19, healthcare worker, functional capacity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minute walk testOther
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. 30 m long corridor is used for this test .
1 minute Sit to Stand TestOther
The 1-minute STS test is performed with a chair of standard height of 46 cm without arm rests. The patient should be ensured to be seated upright on the chair positioned against a wall. The patient sat with the knees and hips flexed to 90°, feet placed flat on the floor hip-width apart, and the hands placed on the hips.The number of repetitions is measured.
Fatigue Severity ScaleOther
The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders
Medical Research Council (MRC) dyspnea scaleOther
The MRC dyspnea scale is a questionnaire that consists of five statements about perceived breathlessness: grade 1, "I only get breathless with strenuous exercise"; grade 2, "I get short of breath when hurrying on the level or up a slight hill"; grade 3, "I walk slower than people of the same age on the level because of breathlessness or have to stop for breath when walking at my own pace on the level"; grade 4, "I stop for breath after walking 100 yards or after a few minutes on the level"; grade 5, " I am too breathless to leave the house".
SF-12Other
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
Beck Depression InventoryOther
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
Beck Anxiety InventoryOther
Beck Anxiety Scale is a 21-item, internationally valid, self-report rating inventory that measures the anxiety level.
5 times sit to stand testOther
The 5XSST scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The equipment need in performing 5XSST test includes: Stopwatch and standard height chair with straight back (43-45 cm, 17-18 inches high). Then the instruction is given by asking the test taker to sit on the chair by resting their back. Also, the test taker is instructed to fold their arms across their chest. Then the test taker should be instructed to do sit-to-stand five times, as quickly as possible, at the count of go and without their back or leg resting on the chair between the interval of repetition.
6 point Likert ScaleOther
Job performance was assessed by asking "How do you evaluate your job performance?" on 6-point Likert scale.A 6 point likert scale forces choice and gives better data.The 6 point Likert scale offers options for ''Excellent, very good, good, fair, poor and very poor''. 6 point scale anges from 1(very poor) to 5 (excellent).
| Study group | Role | What they receive |
|---|---|---|
| Study group (30 volunteer healthcare workers who had Covid-19 | Active comparator | 30 volunteer healthcare workers who had Covid-19 and stayed in hospital or at home were included. Receives: Other: 6 minute walk test; Other: 1 minute Sit to Stand Test; Other: Fatigue Severity Scale; Other: Medical Research Council (MRC) dyspnea scale; Other: SF-12; Other: Beck Depression Inventory; Other: Beck Anxiety Inventory; Other: 5 times sit to stand test; Other: 6 point Likert Scale |
| Control group (30 volunteer healthcare workers who had not have Covid-19) | Active comparator | In control group, 30 volunteer healthcare workers who were matched for age ande gender with study group were included and these persons had not have Covid-19. Receives: Other: 6 minute walk test; Other: 1 minute Sit to Stand Test; Other: Fatigue Severity Scale; Other: Medical Research Council (MRC) dyspnea scale; Other: SF-12; Other: Beck Depression Inventory; Other: Beck Anxiety Inventory; Other: 5 times sit to stand test; Other: 6 point Likert Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 minute sit to stand test
1 minute sit to stand test will be used to measure aerobic capacity and endurance.
Measured: Change at 2nd, 4th and 6th months.
5 times sit to stand test
The five Times Sit to Stand Test (5x Sit-To-Stand Test) commonly abbreviated as 5XSST is used to assesses functional lower extremity strength, transitional movements, balance, and fall risk in older adults
Measured: Change at 2nd, 4th and 6th months.
6 minute walk test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Change at 2nd, 4th and 6th months.
Secondary outcomes (6)
Medical Research Council (MRC) dyspnea scale
Medical Research Council (MRC) dyspnea scale is a questionnaire that consists of five statements about perceived breathlessness in dailt activities.
Measured: Change at 2nd, 4th and 6th months
6 point Likert Scale
Job performance was assessed by asking "How do you evaluate your job performance?" on 6-point Likert scale.
Measured: Change at 2nd, 4th and 6th months.
Fatigue Severity Scale
The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.
Measured: Change at 2nd, 4th and 6th months.
Beck Depression Inventory
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
Measured: Change at 2nd, 4th and 6th months.
Beck Anxiety Scale
Beck Anxiety Scale is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults
Measured: Change at 2nd, 4th and 6th months.
Short form 12
Short form 12 will be used to measure quality of life
Measured: Change at 2nd, 4th and 6th months.
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 start4 Jan 2021
- Primary completion28 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 30 volunteer healthcare workers who had Covid-19 and stayed in hospital or at home were included. In control group, 30 volunteer healthcare workers who were matched for age and gender with study group were included and these persons had not have Covid-19. Healthcare workers who have had Covid-19 disease will be evaluated for the first time within 1 month after their diagnosis with RT-PCR test for SARS-CoV-2 (The condition of completing isolation process of the patients will be sought).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ebru Yilmaz Yalcinkaya, 3, Study chair, University of Health Science,Gaziosmanpasa Training and Research HospitalOzden Ozyemisci Taskiran, 4, Study director, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834739
- Sponsor's protocol ID
- 208
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Functional Capacities of Healthcare Workers With and Without Covid-19
- ClinicalTrials.gov ID
- NCT04834739
- Acronym / sponsor ID
- 208
- Conditions
- Covid19, Functional Capacity
- Keywords
- Covid-19, healthcare worker, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 28 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (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.
This study aimed to investigate if the functional capacity of health workers sustained covid 19 infection effects functional capacity , quality of life and mood of health workers when comparing healthy health workers.
Detailed description
This study was designed in Physical Medicine and Rehabilitation Service of Gaziosmanpasa Training and Research Hospital between January 4 and June 30, 2021.Data of the health workers from our hospital who suffered from Covid-19 disease and matched control group who had not have Covid-19 disease participants were analyzed. Participants signed a general consent .Inclusion criteria; being a health worker over the age of 18 (for both groups), having had SARS-CoV-2 (Covid 19) disease for last 1 month and completed the isolation process, volunteer to participate in the study, , being able to walk or sit and stand without any help, speaking and understand Turkish language. Exclusion criteria (for both study and control group); Neurological or musculoskeletal disease that causes gait impairment, cognitive impairment, having unstable cardiac, respiratory and metabolic disease.(The first assessment will be made within the 1st month after the patient's Covid 19 positivity is detected; control will be made three times in the 2nd, 4th and 6 months)
30 volunteer healthcare workers who had Covid-19 were included to study group. 30 age and gender matched volunteer healthcare workers were included to control group. Healthcare workers who have had Covid-19 disease will be evaluated for the first time within 1 month after their diagnosis with RT-PCR test for SARS-CoV-2.
Symptom questioning will be reported including the initial symptoms of Covid-19 and ongoing complaints of the patients. During the examination, muscle strength will be evaluated by the Medical Research Council (MRC) total score. Resting heart rate, blood pressure and oxygen saturation (by pulse oxymeter) measurement will be applied to both groups before and after the following tests: 1-min sit-to-stand (1MSTS) test, 5 times sit-to-stand (5TSTS) test, 6 minutes walk test (6MWT).
MRC dyspnea scale will be performed as a measure of patient's complaint of shortness of breath,Job performance was assessed by asking "How do you evaluate your job performance?" on 6-point Likert scale, Short Form-12 (Short Form 12, SF-12) will be used to assess quality of life, mood disorder wil be measured by Beck Anxiety Inventory and Beck Depression Inventory, Fatigue severity scale(FSS) will be performed as level of fatigue. The first evaluation wil be made within 1 month after one positive RT-PCR test for SARS-CoV-2 is detected; control evaluations will be made in the 2nd, 4th and 6th months after positivity of RT-PCR test for SARS-CoV-2. Finally, the patient's sex, age, body mass index (BMI), height, education status, career, status of hospitalization, length of hospitalization, comorbidities , pulmonary involvement that diagnosed radiological methods and examination of symptoms related with Covid-19 will be recorded.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 30 volunteer healthcare workers who had Covid-19 and stayed in hospital or at home were included. In control group, 30 volunteer healthcare workers who were matched for age and gender with study group were included and these persons had not have Covid-19. Healthcare workers who have had Covid-19 disease will be evaluated for the first time within 1 month after their diagnosis with RT-PCR test for SARS-CoV-2 (The condition of completing isolation process of the patients will be sought).
| Arm | Type | Receives |
|---|---|---|
| Study group (30 volunteer healthcare workers who had Covid-19 | Active comparator | Other: 6 minute walk test, Other: 1 minute Sit to Stand Test, Other: Fatigue Severity Scale, Other: Medical Research Council (MRC) dyspnea scale, Other: SF-12, Other: Beck Depression Inventory, Other: Beck Anxiety Inventory, Other: 5 times sit to stand test, Other: 6 point Likert Scale30 volunteer healthcare workers who had Covid-19 and stayed in hospital or at home were included. |
| Control group (30 volunteer healthcare workers who had not have Covid-19) | Active comparator | Other: 6 minute walk test, Other: 1 minute Sit to Stand Test, Other: Fatigue Severity Scale, Other: Medical Research Council (MRC) dyspnea scale, Other: SF-12, Other: Beck Depression Inventory, Other: Beck Anxiety Inventory, Other: 5 times sit to stand test, Other: 6 point Likert ScaleIn control group, 30 volunteer healthcare workers who were matched for age ande gender with study group were included and these persons had not have Covid-19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being a health worker over the age of 18 (for both control group)
- Having had SARS-CoV-2 (Covid 19) disease in the last 1 month and completed the isolation process
- Volunteer to participate in the study, being discharged from the hospital and completing the isolation process at home (The first assessment will be made within the 1st month after the patient's Covid 19 positivity is detected; control will be made three times in the 2nd, 4th and 6th months)
- Being able to walk or sit and stand without any help
- Speaking and understand the Turkish language.
Key exclusion criteria (3 listed)
- Neurological or musculoskeletal disease that causes gait impairment
- Cognitive impairment
- Having unstable cardiac, respiratory and metabolic disease
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 |
|---|---|---|
| 6 minute walk testThe 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. 30 m long corridor is used for this test . | Other | Control group (30 volunteer healthcare workers who had not have Covid-19), Study group (30 volunteer healthcare workers who had Covid-19 |
| 1 minute Sit to Stand TestThe 1-minute STS test is performed with a chair of standard height of 46 cm without arm rests. The patient should be ensured to be seated upright on the chair positioned against a wall. The patient sat with the knees and hips flexed to 90°, feet placed flat on the floor hip-width apart, and the hands placed on the hips.The number of repetitions is measured. | Other | Control group (30 volunteer healthcare workers who had not have Covid-19), Study group (30 volunteer healthcare workers who had Covid-19 |
| Fatigue Severity ScaleThe Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders | Other | Control group (30 volunteer healthcare workers who had not have Covid-19), Study group (30 volunteer healthcare workers who had Covid-19 |
| Medical Research Council (MRC) dyspnea scaleThe MRC dyspnea scale is a questionnaire that consists of five statements about perceived breathlessness: grade 1, "I only get breathless with strenuous exercise"; grade 2, "I get short of breath when hurrying on the level or up a slight hill"; grade 3, "I walk slower than people of the same age on the level because of breathlessness or have to stop for breath when walking at my own pace on the level"; grade 4, "I stop for breath after walking 100 yards or after a few minutes on the level"; grade 5, " I am too breathless to leave the house". | Other | Control group (30 volunteer healthcare workers who had not have Covid-19), Study group (30 volunteer healthcare workers who had Covid-19 |
| SF-12The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. | Other | Control group (30 volunteer healthcare workers who had not have Covid-19), Study group (30 volunteer healthcare workers who had Covid-19 |
| Beck Depression InventoryThe Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression | Other | Control group (30 volunteer healthcare workers who had not have Covid-19), Study group (30 volunteer healthcare workers who had Covid-19 |
| Beck Anxiety InventoryBeck Anxiety Scale is a 21-item, internationally valid, self-report rating inventory that measures the anxiety level. | Other | Control group (30 volunteer healthcare workers who had not have Covid-19), Study group (30 volunteer healthcare workers who had Covid-19 |
| 5 times sit to stand testThe 5XSST scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The equipment need in performing 5XSST test includes: Stopwatch and standard height chair with straight back (43-45 cm, 17-18 inches high). Then the instruction is given by asking the test taker to sit on the chair by resting their back. Also, the test taker is instructed to fold their arms across their chest. Then the test taker should be instructed to do sit-to-stand five times, as quickly as possible, at the count of go and without their back or leg resting on the chair between the interval of repetition. | Other | Control group (30 volunteer healthcare workers who had not have Covid-19), Study group (30 volunteer healthcare workers who had Covid-19 |
| 6 point Likert ScaleJob performance was assessed by asking "How do you evaluate your job performance?" on 6-point Likert scale.A 6 point likert scale forces choice and gives better data.The 6 point Likert scale offers options for ''Excellent, very good, good, fair, poor and very poor''. 6 point scale anges from 1(very poor) to 5 (excellent). | Other | Control group (30 volunteer healthcare workers who had not have Covid-19), Study group (30 volunteer healthcare workers who had Covid-19 |
Primary outcome
1 minute sit to stand test
Time frame: Change at 2nd, 4th and 6th months.
1 minute sit to stand test will be used to measure aerobic capacity and endurance.
5 times sit to stand test
Time frame: Change at 2nd, 4th and 6th months.
The five Times Sit to Stand Test (5x Sit-To-Stand Test) commonly abbreviated as 5XSST is used to assesses functional lower extremity strength, transitional movements, balance, and fall risk in older adults
6 minute walk test
Time frame: Change at 2nd, 4th and 6th months.
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
6 secondary outcomes
Medical Research Council (MRC) dyspnea scale
Time frame: Change at 2nd, 4th and 6th months
6 point Likert Scale
Time frame: Change at 2nd, 4th and 6th months.
Fatigue Severity Scale
Time frame: Change at 2nd, 4th and 6th months.
Beck Depression Inventory
Time frame: Change at 2nd, 4th and 6th months.
Beck Anxiety Scale
Time frame: Change at 2nd, 4th and 6th months.
Short form 12
Time frame: Change at 2nd, 4th and 6th months.
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 24 Aug 2021.
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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.
Ebru Yilmaz Yalcinkaya, 3 study chair
University of Health Science,Gaziosmanpasa Training and Research Hospital
Ozden Ozyemisci Taskiran, 4 study director
Koç 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 6 minute walk test, 1 minute Sit to Stand Test and Fatigue Severity Scale in people with Covid19 and Functional Capacity, run by Gaziosmanpasa Research and Education 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 5 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 24 Aug 2021. 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?
1 minute sit to stand test (time frame: Change at 2nd, 4th and 6th months.). The study lists 3 primary outcomes in all. 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 24 Aug 2021.