Sarcopenia in ElderlyNCT06868602
Effects of Regular Exercise and Psychoeducation on Quality of Life and Depression in the Treatment of Sarcopenia
A study testing psychoeducation and Exercise in people with Sarcopenia in Elderly, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to observe the effect of psychoeducation, which has not yet been included among the treatment methods of sarcopenia, which affects elderly individuals both physically and psychologically and has been proven to negatively affect their quality of life, on Quality of Life, Depression and… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Sarcopenia in Elderly
- What is being tested?
- psychoeducation and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 28 Sep 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 60 and over who have signed a consent form and agreed to volunteer for the study.
- Individuals classified as sarcopenic according to the criteria of the European Working Group on Sarcopenia (EWGSOP2).
- Individuals who scored 24 points or higher on the Standardized Mini Mental Test.
Who cannot join
- Individuals with neurological disease,
- Individuals with advanced kidney disease,
- Individuals with pacemakers,
- Individuals with advanced vision and hearing problems,
- Individuals with advanced dementia,
- Individuals with orthopedic disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Regular Exercise and Psychoeducation on Quality of Life, Depression and Physical Function in the Treatment of Sarcopenia in Elderly Individuals
In this study, it was aimed to observe the effect of psychoeducation, which has not yet been included among the treatment methods of sarcopenia, which affects elderly individuals both physically and psychologically and has been proven to negatively affect their quality of life, on Quality of Life, Depression and Physical Function when applied with exercise therapy.
It is known that exercise programs applied in the treatment of sarcopenia, which has become a common problem in elderly individuals and is known as the trigger of most symptomatic diseases, have positive effects.
Read more
However, no psychoeducation program has been applied to date in the treatment of sarcopenia, which is thought to trigger psychological factors as well as physical factors.
In this direction, it is aimed to contribute to sarcopenia treatment and indirectly to geriatric rehabilitation programs according to the results we will obtain in sarcopenic individuals with the psychoeducation program, which we think is lacking.
In addition to all these, sarcopenia, which is a treatable diagnosis and one of the biggest obstacles to the independent life of elderly individuals, is thought to be a preventable condition with preventive rehabilitation programs.
Researchers believe that preventive rehabilitation programs will positively affect the amount spent on elderly care services, which constitute a large portion of our country's health expenses, and Researchers aim to support these issues with the results they will obtain.
Read the detailed description
This study was planned to examine the effectiveness of exercise and psychoeducation programs applied to sarcopenic individuals.
Sarcopenia, which causes muscle strength loss in elderly individuals, is shown as a risk factor for many negative outcomes ranging from fractures to death.
Sarcopenia, which is also shown as the cause of many metabolic diseases, is often a preventable disease, but it is seen that scientific studies on sarcopenia treatment in the academic field are not sufficient.
While the majority of the studies conducted include physiotherapy programs, the psychological dimension of the treatment has been ignored and although it has been associated with depression, no scientific study has been found that includes this psychoeducation program.
The physical problems experienced by sarcopenic individuals are basically movement disorders that occur due to muscle strength loss, along with deterioration in their quality of life and physical functions, and musculoskeletal system diseases.
However, sarcopenia is a multifaceted disease that is not only physical but also causes psychological diseases such as depression.
In addition, it is known that physical function loss, which is one of the symptoms of sarcopenia, has a negative effect on the level of depression, independent of sarcopenia.
In light of all this information, it is thought that if the treatment program prepared for sarcopenic individuals does not include a psychoeducation program together with the physiotherapy program, a part of the treatment will be incomplete.
This study, which researchers designed to investigate the psychoeducation program, the therapeutic effect of which is not yet known on sarcopenia, aims to contribute to this area.
It is aimed to reach a conclusion by comparing the differences between the Physical Function, Quality of Life and Depression parameters of the psychoeducation program combined with the exercise program in sarcopenic individuals and the sarcopenic individuals who only received the exercise program.
- Conditions
- Sarcopenia in Elderly
- Being tested
- psychoeducation, Exercise
- Keywords
- sarcopenia, exercise, psychoeducation
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducationOther
Also called exercise
Although the literature investigating the effectiveness of exercise programs on quality of life, physical function and depression in sarcopenic individuals is extensive, no studies have been found in which psychoeducation programs are applied to sarcopenic individuals and their effectiveness is investigated. In this planned study,Researchers aim to observe what kind of results will emerge and in what direction the psychoeducation program will shape the treatment by applying both exercise and psychoeducation programs to sarcopenic individuals.
ExerciseOther
Although the literature investigating the effectiveness of exercise programs on quality of life, physical function and depression in sarcopenic individuals is extensive, no studies have been found in which psychoeducation programs are applied to sarcopenic individuals and their effectiveness is investigated. In this planned study, Researchers aim to observe what kind of results will emerge and in what direction the psychoeducation program will shape the treatment by applying both exercise and psychoeducation programs to sarcopenic individuals.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | This group will be informed about exercise and psychoeducation only once after the sessions are completed. |
| exercise | Active comparator | Physical exercise will be performed for 45 minutes twice a week for eight weeks. Receives: Other: Exercise |
| exercise and psychoeducation | Active comparator | A 45-minute exercise program twice a week and a 45-minute psychoeducation program once a week will be implemented for 8 weeks. Receives: Other: psychoeducation; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
TUG test
A chair and a stopwatch are required for the test, which evaluates the risk of falls and mobility in the elderly. The test is performed with the shoes the individual always uses. A 3-meter area is determined in front of the chair. The individual is asked to get up from the chair, walk this distance, and sit down again.
Measured: Before treatment
SF-12 Test
It is an abbreviated form for assessing quality of life. This form, developed by Ware et al. (1995), is not specific to any age or type of disease, but is a scale that assesses the person's quality of life over the last four weeks. SF-12; It includes the sub-elements of physical functioning, physical role, pain, general health, emotional role, mental health, social functioning and vitality and consists of 12 questions.
Measured: Before treatment
GDS
This scale was developed by Yesavage et al. (1983). The Turkish adaptation of the scale was made by Ertan et al. The scale is self-reporting, aimed at the elderly, easy to answer and consists of 30 questions. A higher score indicates a higher level of depression.
Measured: Before treatment
Bioelectrical impedance analysis (BIA)
Bioelectrical impedance analysis (BIA) measurement; It is a non-invasive measurement. It takes advantage of the different resistance of different tissues in the body to currents. A weak electric current is directed to the body and the impedance is measured. It is used to estimate body composition parameters such as total body water and fat-free mass.
Measured: Before treatment
SARC-F
SARC-F; It allows health professionals to quickly and easily assess the risk of sarcopenia in primary health care. It asks 5 questions about "strength, assistance while walking, getting up from a chair, climbing stairs and falling". The SARC-F score range is from 0 to 10, with a score range of 0-3 representing a healthy condition and a score range of 4 and above representing a symptomatic condition.
Measured: Before treatment
Standardized Mini Mental Test (SMMT)
Mini Mental Test developed by Folstein et al. (1975) allows for cognitive assessment in a short time. In this respect, SMMT is a short, easy-to-apply and standardized test used to determine the cognitive level globally.
Measured: Before treatment , pre test only
Handgrip strength assessment
During the assessment, the individual is seated upright on a chair without surface support for the arm being assessed. The arm to be measured is positioned in a free position, with the knee angle and elbow angle at 90 degrees. The subject is asked to squeeze the dynamometer with their fingers as hard and tight as possible. The measurements are repeated 3 times, with 10 seconds between them and each measurement being no less than 5 seconds, and any interventions that may affect the measurements during the assessment are avoided.
Measured: Before treatment
Secondary outcomes (5)
TUG test
A chair and a stopwatch are required for the test, which evaluates the risk of falls and mobility in the elderly. The test is performed with the shoes the individual always uses. A 3-meter area is determined in front of the chair. The individual is asked to get up from the chair, walk this distance, and sit down again.
Measured: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
SF-12 Test
It is an abbreviated form for assessing quality of life. This form, developed by Ware et al. (1995), is not specific to any age or type of disease, but is a scale that assesses the person's quality of life over the last four weeks. SF-12; It includes the sub-elements of physical functioning, physical role, pain, general health, emotional role, mental health, social functioning and vitality and consists of 12 questions.
Measured: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
GDS
This scale was developed by Yesavage et al. (1983). The Turkish adaptation of the scale was made by Ertan et al. The scale is self-reporting, aimed at the elderly, easy to answer and consists of 30 questions. A higher score indicates a higher level of depression.
Measured: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
Bioelectrical impedance analysis (BIA)
Bioelectrical impedance analysis (BIA) measurement; It is a non-invasive measurement. It takes advantage of the different resistance of different tissues in the body to currents. A weak electric current is directed to the body and the impedance is measured. It is used to estimate body composition parameters such as total body water and fat-free mass.
Measured: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
Handgrip strength assessment
During the assessment, the individual is seated upright on a chair without surface support for the arm being assessed. The arm to be measured is positioned in a free position, with the knee angle and elbow angle at 90 degrees. The subject is asked to squeeze the dynamometer with their fingers as hard and tight as possible. The measurements are repeated 3 times, with 10 seconds between them and each measurement being no less than 5 seconds, and any interventions that may affect the measurements during the assessment are avoided.
Measured: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Jun 2024
- Primary completion15 Jun 2024
- Study completion28 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcopenia in ElderlyStudies 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
- In this study, a pre-test-post-test randomized control and placebo group quasi-experimental research design will be used. In order to determine whether elderly individuals who voluntarily accept to participate in the study are sarcopenic according to the definitive diagnostic criteria of the European Working Group (EWGSOP2), muscle strength assessment (with a handheld dynamometer), muscle mass assessment (with a Bioelectrical Impedance (BIA) device) and Physical performance assessment (with the Timed Up and Go test and SARC-F test) will be performed; then, the SMMT will be applied to sarcopenic individuals and those who score 24 points and above and meet the inclusion criteria will be included in the study. Elderly individuals who meet the inclusion criteria will be assigned to the group where exercise will be performed, the group where exercise and psychoeducation will be done together, and the control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Asan, Lokman Hekim University
- Investigators
- Esra Erdoğan, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868602
- Sponsor's protocol ID
- 2023-664
- Other IDs
- BAP01-2024-5152
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD collected
Publications
Erdogan E, Asan E, Yaran M. The effects of regular exercise and psychoeducation on quality of life, depression, and physical function in older adults with sarcopenia: A single-blind randomized controlled trial. Geriatr Nurs. 2026 Oct 31;74(Pt B):104415. doi: 10.1016/j.gerinurse.2026.104415. Online ahead of print.
PubMed 42966207
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Regular Exercise and Psychoeducation on Quality of Life, Depression and Physical Function in the Treatment of Sarcopenia in Elderly Individuals
- ClinicalTrials.gov ID
- NCT06868602
- Acronym / sponsor ID
- 2023-664
- Conditions
- Sarcopenia in Elderly
- Keywords
- sarcopenia, exercise, psychoeducation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 28 Sep 2024 (actual)
- First posted
- 11 Mar 2025 (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.
In this study, it was aimed to observe the effect of psychoeducation, which has not yet been included among the treatment methods of sarcopenia, which affects elderly individuals both physically and psychologically and has been proven to negatively affect their quality of life, on Quality of Life, Depression and Physical Function when applied with exercise therapy.
It is known that exercise programs applied in the treatment of sarcopenia, which has become a common problem in elderly individuals and is known as the trigger of most symptomatic diseases, have positive effects.
However, no psychoeducation program has been applied to date in the treatment of sarcopenia, which is thought to trigger psychological factors as well as physical factors.
In this direction, it is aimed to contribute to sarcopenia treatment and indirectly to geriatric rehabilitation programs according to the results we will obtain in sarcopenic individuals with the psychoeducation program, which we think is lacking.
In addition to all these, sarcopenia, which is a treatable diagnosis and one of the biggest obstacles to the independent life of elderly individuals, is thought to be a preventable condition with preventive rehabilitation programs.
Researchers believe that preventive rehabilitation programs will positively affect the amount spent on elderly care services, which constitute a large portion of our country's health expenses, and Researchers aim to support these issues with the results they will obtain.
Detailed description
This study was planned to examine the effectiveness of exercise and psychoeducation programs applied to sarcopenic individuals.
Sarcopenia, which causes muscle strength loss in elderly individuals, is shown as a risk factor for many negative outcomes ranging from fractures to death.
Sarcopenia, which is also shown as the cause of many metabolic diseases, is often a preventable disease, but it is seen that scientific studies on sarcopenia treatment in the academic field are not sufficient.
While the majority of the studies conducted include physiotherapy programs, the psychological dimension of the treatment has been ignored and although it has been associated with depression, no scientific study has been found that includes this psychoeducation program.
The physical problems experienced by sarcopenic individuals are basically movement disorders that occur due to muscle strength loss, along with deterioration in their quality of life and physical functions, and musculoskeletal system diseases.
However, sarcopenia is a multifaceted disease that is not only physical but also causes psychological diseases such as depression.
In addition, it is known that physical function loss, which is one of the symptoms of sarcopenia, has a negative effect on the level of depression, independent of sarcopenia.
In light of all this information, it is thought that if the treatment program prepared for sarcopenic individuals does not include a psychoeducation program together with the physiotherapy program, a part of the treatment will be incomplete.
This study, which researchers designed to investigate the psychoeducation program, the therapeutic effect of which is not yet known on sarcopenia, aims to contribute to this area.
It is aimed to reach a conclusion by comparing the differences between the Physical Function, Quality of Life and Depression parameters of the psychoeducation program combined with the exercise program in sarcopenic individuals and the sarcopenic individuals who only received the exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- In this study, a pre-test-post-test randomized control and placebo group quasi-experimental research design will be used. In order to determine whether elderly individuals who voluntarily accept to participate in the study are sarcopenic according to the definitive diagnostic criteria of the European Working Group (EWGSOP2), muscle strength assessment (with a handheld dynamometer), muscle mass assessment (with a Bioelectrical Impedance (BIA) device) and Physical performance assessment (with the Timed Up and Go test and SARC-F test) will be performed; then, the SMMT will be applied to sarcopenic individuals and those who score 24 points and above and meet the inclusion criteria will be included in the study. Elderly individuals who meet the inclusion criteria will be assigned to the group where exercise will be performed, the group where exercise and psychoeducation will be done together, and the control group.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –This group will be informed about exercise and psychoeducation only once after the sessions are completed. |
| exercise | Active comparator | Other: ExercisePhysical exercise will be performed for 45 minutes twice a week for eight weeks. |
| exercise and psychoeducation | Active comparator | Other: psychoeducation, Other: ExerciseA 45-minute exercise program twice a week and a 45-minute psychoeducation program once a week will be implemented for 8 weeks. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 60 and over who have signed a consent form and agreed to volunteer for the study.
- Individuals classified as sarcopenic according to the criteria of the European Working Group on Sarcopenia (EWGSOP2).
- Individuals who scored 24 points or higher on the Standardized Mini Mental Test.
Key exclusion criteria (6 listed)
- Individuals with neurological disease,
- Individuals with advanced kidney disease,
- Individuals with pacemakers,
- Individuals with advanced vision and hearing problems,
- Individuals with advanced dementia,
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 |
|---|---|---|
| psychoeducationAlso: exerciseAlthough the literature investigating the effectiveness of exercise programs on quality of life, physical function and depression in sarcopenic individuals is extensive, no studies have been found in which psychoeducation programs are applied to sarcopenic individuals and their effectiveness is investigated. In this planned study,Researchers aim to observe what kind of results will emerge and in what direction the psychoeducation program will shape the treatment by applying both exercise and psychoeducation programs to sarcopenic individuals. | Other | exercise and psychoeducation |
| ExerciseAlthough the literature investigating the effectiveness of exercise programs on quality of life, physical function and depression in sarcopenic individuals is extensive, no studies have been found in which psychoeducation programs are applied to sarcopenic individuals and their effectiveness is investigated. In this planned study, Researchers aim to observe what kind of results will emerge and in what direction the psychoeducation program will shape the treatment by applying both exercise and psychoeducation programs to sarcopenic individuals. | Other | exercise, exercise and psychoeducation |
Primary outcome
TUG test
Time frame: Before treatment
A chair and a stopwatch are required for the test, which evaluates the risk of falls and mobility in the elderly. The test is performed with the shoes the individual always uses. A 3-meter area is determined in front of the chair. The individual is asked to get up from the chair, walk this distance, and sit down again.
SF-12 Test
Time frame: Before treatment
It is an abbreviated form for assessing quality of life. This form, developed by Ware et al. (1995), is not specific to any age or type of disease, but is a scale that assesses the person's quality of life over the last four weeks. SF-12; It includes the sub-elements of physical functioning, physical role, pain, general health, emotional role, mental health, social functioning and vitality and consists of 12 questions.
GDS
Time frame: Before treatment
This scale was developed by Yesavage et al. (1983). The Turkish adaptation of the scale was made by Ertan et al. The scale is self-reporting, aimed at the elderly, easy to answer and consists of 30 questions. A higher score indicates a higher level of depression.
Bioelectrical impedance analysis (BIA)
Time frame: Before treatment
Bioelectrical impedance analysis (BIA) measurement; It is a non-invasive measurement. It takes advantage of the different resistance of different tissues in the body to currents. A weak electric current is directed to the body and the impedance is measured. It is used to estimate body composition parameters such as total body water and fat-free mass.
SARC-F
Time frame: Before treatment
SARC-F; It allows health professionals to quickly and easily assess the risk of sarcopenia in primary health care. It asks 5 questions about "strength, assistance while walking, getting up from a chair, climbing stairs and falling". The SARC-F score range is from 0 to 10, with a score range of 0-3 representing a healthy condition and a score range of 4 and above representing a symptomatic condition.
Standardized Mini Mental Test (SMMT)
Time frame: Before treatment , pre test only
Mini Mental Test developed by Folstein et al. (1975) allows for cognitive assessment in a short time. In this respect, SMMT is a short, easy-to-apply and standardized test used to determine the cognitive level globally.
Handgrip strength assessment
Time frame: Before treatment
During the assessment, the individual is seated upright on a chair without surface support for the arm being assessed. The arm to be measured is positioned in a free position, with the knee angle and elbow angle at 90 degrees. The subject is asked to squeeze the dynamometer with their fingers as hard and tight as possible. The measurements are repeated 3 times, with 10 seconds between them and each measurement being no less than 5 seconds, and any interventions that may affect the measurements during the assessment are avoided.
5 secondary outcomes
TUG test
Time frame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
SF-12 Test
Time frame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
GDS
Time frame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
Bioelectrical impedance analysis (BIA)
Time frame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
Handgrip strength assessment
Time frame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
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 11 Mar 2025.
- Derived from this study: PubMed 42966207Erdogan E, Asan E, Yaran M. The effects of regular exercise and psychoeducation on quality of life, depression, and physical function in older adults with sarcopenia: A single-blind randomized controlled trial. Geriatr Nurs. 2026 Oct 31;74(Pt B):104415. doi: 10.1016/j.gerinurse.2026.104415. Online ahead of print.
- Individual participant dataSharing planned: No. All IPD collected
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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.
Esra Erdoğan study director
Ondokuz Mayıs 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 psychoeducation and Exercise in people with Sarcopenia in Elderly, run by Lokman Hekim 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 3 inclusion and 6 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 11 Mar 2025. 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?
TUG test (time frame: Before treatment). The study lists 7 primary outcomes in all. 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 NCT06868602, which also lists 1 linked publication.
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 11 Mar 2025.