Type 2 DiabetesNCT07165119
The Effect of the Interdisciplinary Care Approach on General Health Parameters in Older Adults With Type 2 Diabetes
A study testing Interdisciplinary group, Clinical Pilates Group and Nurse Coaching group in people with Type 2 Diabetes, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was evaluation of the effect of the clinical Pilates, nurse coaching and Peer group work Approach on General Health Parameters in older adults with Diabetes. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Interdisciplinary group, Clinical Pilates Group and Nurse Coaching group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 Dec 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 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- individuals who were independently mobile,
- had been diagnosed with Type 2 Diabetes for a minimum of six months,
- had no serious complications or mental health issues,
- participated in regular medical check-ups,
- had no communication problems,
- agreed to participate in the study voluntarily
- aged 65 years or older.
Who cannot join
- older adults with a standardized mini-mental state examination (MMSE) score below 17
- older adults with serious complications that prevented them from participating in group activities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çankırı Karatekin University Eldivan Vocational School of Health Services
Çankırı, 18100
About this study
Official title: The Effect of the Clinical Pilates, Nurse Coaching and Peer Group Work Approach on General Health Parameters in the Elderly With Diabetes: A Randomized Controlled
The aim of the study was evaluation of the effect of the clinical Pilates, nurse coaching and Peer group work Approach on General Health Parameters in older adults with Diabetes. This study was conducted as a single-blind, 4-arm, single-randomized and controlled study to estimate the effect of clinical Pilates, nurse coaching and peer group work approach on general health parameters in elderly individuals with diabetes mellitus. Interdisciplinary group treatment was carried out by a physiotherapist, social worker, diabetes nurse, and family physician. Clinical Pilates group treatment was carried out by a physiotherapist, and nurse coaching group treatment was carried out by a diabetes nurse. Measurements of the functional capacity of the elderly were evaluated with the Lafayette manual muscle tester and the Jamar hydraulic hand grip dynamometer. A total of 48 aged people with diabetes were randomized into 4 arms. The arms were followed up for 12 weeks.
Read the detailed description
In line with the global trend, the elderly population is increasing in Turkey and the prevalence of diabetes in the elderly population continues to be high. According to the results of the Turkish Diabetes Epidemiology Study (TURDEP2), diabetic patients over the age of 65 constitute approximately 40% of all diabetics. Diabetes in an older person also increases the risk of developing frailty syndrome, which is associated with reduced muscle strength, reduced muscle quality and loss of muscle mass and accelerated aging. Muscle strength and function are reduced in diabetic patients with type 2 diabetes compared to healthy, non-glycemic individuals, with an increase in BMI and a decrease in muscle quality, when estrogen drops, especially in menopausal women. However, people with T2D may have an increased risk of falls and fractures, which may be partly explained by a decrease in muscle mass. Limited mobility can have a major impact on the individual's independence when basic daily activities like getting up from the chair, climbing stairs, and grocery shopping are disrupted for the elderly person. Decreased muscle strength can be an important factor in this loss of mobility.
In addition to physical changes, diabetes in older people also leads to emotional, mental and social difficulties and conflicts. Negative experiences such as anxiety, depression, tension and lack of social support in individuals with diabetes have bad consequences on diabetes, exacerbate the disease and increase the burden of the disease on the individual. According to the preliminary findings of the National Burden of Disease Research performed in Turkey, it has been reported that there has been a 60% increase in the burden of illness related to diabetes and that it ranks first among the burden-causing diseases. In line with all these results, a holistic approach to the phenomenon of diabetes will provide holistic interventions for the multiple effects of diabetes. However, interventions about diabetes management for the diabetic elderly are limited in the literature. Many studies have been conducted with diabetic elderly people. However, this study is the first study that includes an interdisciplinary group study for diabetic elders. The present study was organized to assess the effectiveness of these practices of an interdisciplinary care approach on the general health parameters of elderly individuals with Type 2 Diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- Interdisciplinary group, Clinical Pilates Group, Nurse Coaching group
- Keywords
- elderly diabetic, nurse coaching, Pilates, interdisciplinary care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary groupOther
For 12 weeks, the subjects in the interdisciplinary group participated in 45 minutes of clinical Pilates three times a week, as in the clinical Pilates group, and 45 minutes of nurse coaching once a week, as in the nurse coaching group.
Clinical Pilates GroupOther
Clinical Pilates was applied by a certified physiotherapist for 12 consecutive weeks. with 45-minute sessions 3 times a week and was delivered to small groups of participants (3-5). The Pilates program has been developed in accordance with the extant literature to cultivate strength, balance, and coordination in a range of body positions, including the supine, seated, kneeling, and standing positions. Participants were instructed to perform each movement with control and precision, focusing on proper breathing patterns (exhaling during flexion, inhaling during extension) and engaging their core muscles throughout the exercise The load level and progression were determined using the Borg CR10 scale: Borg ≤ 2 = light load; Borg > 2 - < 5 = moderate load; Borg ≥ 5 - < 7 = heavy load; Borg ≥ 7 = near-maximum load. During the sessions, the effort level was generally maintained at a moderate intensity (Borg 3-4). Each time the intensity of the exercise was changed, the new loa
Nurse Coaching groupOther
Training and follow-up was carried out with nurse coaching for 12 weeks lasting 45 minutes once a week .
| Study group | Role | What they receive |
|---|---|---|
| Interdisciplinary group | Experimental | For 12 weeks, 3 times interdisciplinary treatment for 12 participants. Receives: Other: Interdisciplinary group |
| Nurse Coaching group | Active comparator | nurse coaching for 12 weeks lasting 45 minutes once a week for 12 participants. Receives: Other: Nurse Coaching group |
| Clinical Pilates group | Active comparator | Clinical Pilates For 12 weeks, 3 times exercise for 12 participants. Receives: Other: Clinical Pilates Group |
| Control group | No intervention | Control group: 12 week waiting list for 12 participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Anxiety Inventory
The scale's main feature is its ability to differentiate between anxious and non-anxious groups, as well as between those with and without generalised anxiety disorder. The Turkish version of the Geriatric Anxiety Inventory was used. Scores obtained from the scale range from 0 to 20. Higher scores indicate higher anxiety levels in older individuals.
Measured: From enrollment to the end of treatment at 12 weeks.
Glycosylated hemoglobin
The glycosylated hemoglobin level is measured as a percentage according to the reference protocol of the International Federation of Clinical Chemistry. Blood samples from each patient were collected in the morning after fasting, with glycosylated hemoglobin level measurements taken one week before and again at the end of the 12-week period.
Measured: From enrollment to the end of treatment at 12 weeks.
Berg Balance Scale
The Berg Balance Scale is a 14-item scale that quantitatively evaluates balance and fall risk. Performance is directly observed. Scores of 0 to 20 represent a lack of balance, 21 to 40 indicate acceptable balance and 41 to 56 show good balance. This scale can be used to evaluate both static and dynamic balance
Measured: From enrollment to the end of treatment at 12 weeks.
Yesavage Geriatric Depression Scale
The scale developed by Yesavage et al., consists of 30 questions and is used as a basic screening criterion for major and minor depression. Data obtained using the Yesavage Geriatric Depression Scale were categorized as follows: 'no depression' for individuals with a score below 11; 'probable depression' for individuals with a score between 12 and 14; and 'depression' for individuals with a score of 14 or above
Measured: From enrollment to the end of treatment at 12 weeks.
Type 2 Diabetes Self-Management Scale
The scale allows for individualized assessments of lifestyle, blood glucose management and healthcare utilisation in people with type 2 Diabetes. The scale consists of 19 items across three dimensions. The healthy lifestyle behaviours subscale contains 11 items; the blood glucose management subscale contains four items; and the utilizing health services subscale contains four items
Measured: From enrollment to the end of treatment at 12 weeks
Elderly Diabetes Burden Scale
Araki et al. developed the scale for assessing diabetic-specific psychological aspects with 6 subscales (symptom burden, dietary restrictions, social burden, worry about diabetes, treatment dissatisfaction, and burden by tablets or insulin). The total score range for this scale is 18-88. Validity and reliability in Turkish were examined by Usta and Esen in 2012. An increase in scale scores indicates an increase in the burden in that area, and a decrease in scores indicates a low burden in that area. The Cronbach alpha coefficient for the scale was found to be 0.92
Measured: From enrollment to the end of treatment at 12 weeks.
30 Seconds Sit to Stand Test
In the study, the 30 second sit-stand test was used, which evaluates lower body strength and endurance in older adults. Protocol developed by Rikli and Jones to determine the physical fitness levels of older adults between the ages of 60-94. The patient is asked to sit and then stand unaided for 30 seconds, and performing less than 8 repetitions is a risk indicator
Measured: From enrollment to the end of treatment at 12 weeks.
Timed Up&Go Test
The Timed Up\&Go Test includes independent measures of mobility and functional ability, including standing up from a chair, walking, turning, stopping, and sitting again. The person is asked to get up from the chair they are sitting in, walk 3 meters, come back and sit on the chair again, and the elapsed time is recorded
Measured: From enrollment to the end of treatment at 12 weeks.
Gait speed measurement
Participants were asked to walk along a 4-metre track at their normal speed. This is an effective way of determining a person's physical function. Those who generally walk faster than 1 m/s tend to have a better functional status, a lower risk of health problems, and a higher survival rate
Measured: From enrollment to the end of treatment at 12 weeks.
Hand Grip Strength
Muscle strength was evaluated through handgrip measurements using a handheld dynamometer (TKK 5001. Grip-A; Takei. Tokyo. Japan). Each participant completed three maximal grip trials with the left hand, followed by three with the right, with 1-min rest intervals between attempts. The test is a determinant of age-related decline in physical function
Measured: From enrollment to the end of treatment at 12 weeks.
Strength of Upper/Lower Limbs
The handheld dynamometer (HHD), which measures isometric muscle strength, is a simple to use, easy to carry, inexpensive and light device. Quadriceps femoris, hamstring, tibialis anterior, iliopsoas, gluteus medius, biceps brachii, and shoulder abductor muscles evaluated with a handheld dynamometer
Measured: From enrollment to the end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 May 2021
- Primary completion1 Sep 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was carried out as a single-blind, 4-arm randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Çankırı Karatekin University
- Responsible party
- Principal investigator, Kutay Kaslı, Çankırı Karatekin University
- Investigators
- Huri Seval Gönderen Çakmak, Phd, Study director, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165119
- Sponsor's protocol ID
- 435
- Other IDs
- Kutay Kaşlı
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be added to the university's library and researchers can reach If they login to library's webpage. https://kutuphane.karatekin.edu.tr/.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Clinical Pilates, Nurse Coaching and Peer Group Work Approach on General Health Parameters in the Elderly With Diabetes: A Randomized Controlled
- ClinicalTrials.gov ID
- NCT07165119
- Acronym / sponsor ID
- 435
- Conditions
- Type 2 Diabetes
- Keywords
- elderly diabetic, nurse coaching, Pilates, interdisciplinary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Çankırı Karatekin University
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 10 Sep 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.
The aim of the study was evaluation of the effect of the clinical Pilates, nurse coaching and Peer group work Approach on General Health Parameters in older adults with Diabetes. This study was conducted as a single-blind, 4-arm, single-randomized and controlled study to estimate the effect of clinical Pilates, nurse coaching and peer group work approach on general health parameters in elderly individuals with diabetes mellitus. Interdisciplinary group treatment was carried out by a physiotherapist, social worker, diabetes nurse, and family physician. Clinical Pilates group treatment was carried out by a physiotherapist, and nurse coaching group treatment was carried out by a diabetes nurse. Measurements of the functional capacity of the elderly were evaluated with the Lafayette manual muscle tester and the Jamar hydraulic hand grip dynamometer. A total of 48 aged people with diabetes were randomized into 4 arms. The arms were followed up for 12 weeks.
Detailed description
In line with the global trend, the elderly population is increasing in Turkey and the prevalence of diabetes in the elderly population continues to be high. According to the results of the Turkish Diabetes Epidemiology Study (TURDEP2), diabetic patients over the age of 65 constitute approximately 40% of all diabetics. Diabetes in an older person also increases the risk of developing frailty syndrome, which is associated with reduced muscle strength, reduced muscle quality and loss of muscle mass and accelerated aging. Muscle strength and function are reduced in diabetic patients with type 2 diabetes compared to healthy, non-glycemic individuals, with an increase in BMI and a decrease in muscle quality, when estrogen drops, especially in menopausal women. However, people with T2D may have an increased risk of falls and fractures, which may be partly explained by a decrease in muscle mass. Limited mobility can have a major impact on the individual's independence when basic daily activities like getting up from the chair, climbing stairs, and grocery shopping are disrupted for the elderly person. Decreased muscle strength can be an important factor in this loss of mobility.
In addition to physical changes, diabetes in older people also leads to emotional, mental and social difficulties and conflicts. Negative experiences such as anxiety, depression, tension and lack of social support in individuals with diabetes have bad consequences on diabetes, exacerbate the disease and increase the burden of the disease on the individual. According to the preliminary findings of the National Burden of Disease Research performed in Turkey, it has been reported that there has been a 60% increase in the burden of illness related to diabetes and that it ranks first among the burden-causing diseases. In line with all these results, a holistic approach to the phenomenon of diabetes will provide holistic interventions for the multiple effects of diabetes. However, interventions about diabetes management for the diabetic elderly are limited in the literature. Many studies have been conducted with diabetic elderly people. However, this study is the first study that includes an interdisciplinary group study for diabetic elders. The present study was organized to assess the effectiveness of these practices of an interdisciplinary care approach on the general health parameters of elderly individuals with Type 2 Diabetes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The study was carried out as a single-blind, 4-arm randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary group | Experimental | Other: Interdisciplinary groupFor 12 weeks, 3 times interdisciplinary treatment for 12 participants. |
| Nurse Coaching group | Active comparator | Other: Nurse Coaching groupnurse coaching for 12 weeks lasting 45 minutes once a week for 12 participants. |
| Clinical Pilates group | Active comparator | Other: Clinical Pilates GroupClinical Pilates For 12 weeks, 3 times exercise for 12 participants. |
| Control group | No intervention | –Control group: 12 week waiting list for 12 participants. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- individuals who were independently mobile,
- had been diagnosed with Type 2 Diabetes for a minimum of six months,
- had no serious complications or mental health issues,
- participated in regular medical check-ups,
- had no communication problems,
Key exclusion criteria (2 listed)
- older adults with a standardized mini-mental state examination (MMSE) score below 17
- older adults with serious complications that prevented them from participating in group activities
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 |
|---|---|---|
| Interdisciplinary groupFor 12 weeks, the subjects in the interdisciplinary group participated in 45 minutes of clinical Pilates three times a week, as in the clinical Pilates group, and 45 minutes of nurse coaching once a week, as in the nurse coaching group. | Other | Interdisciplinary group |
| Clinical Pilates GroupClinical Pilates was applied by a certified physiotherapist for 12 consecutive weeks. with 45-minute sessions 3 times a week and was delivered to small groups of participants (3-5). The Pilates program has been developed in accordance with the extant literature to cultivate strength, balance, and coordination in a range of body positions, including the supine, seated, kneeling, and standing positions. Participants were instructed to perform each movement with control and precision, focusing on proper breathing patterns (exhaling during flexion, inhaling during extension) and engaging their core muscles throughout the exercise The load level and progression were determined using the Borg CR10 scale: Borg ≤ 2 = light load; Borg > 2 - < 5 = moderate load; Borg ≥ 5 - < 7 = heavy load; Borg ≥ 7 = near-maximum load. During the sessions, the effort level was generally maintained at a moderate intensity (Borg 3-4). Each time the intensity of the exercise was changed, the new loa | Other | Clinical Pilates group |
| Nurse Coaching groupTraining and follow-up was carried out with nurse coaching for 12 weeks lasting 45 minutes once a week . | Other | Nurse Coaching group |
Primary outcome
Geriatric Anxiety Inventory
Time frame: From enrollment to the end of treatment at 12 weeks.
The scale's main feature is its ability to differentiate between anxious and non-anxious groups, as well as between those with and without generalised anxiety disorder. The Turkish version of the Geriatric Anxiety Inventory was used. Scores obtained from the scale range from 0 to 20. Higher scores indicate higher anxiety levels in older individuals.
Glycosylated hemoglobin
Time frame: From enrollment to the end of treatment at 12 weeks.
The glycosylated hemoglobin level is measured as a percentage according to the reference protocol of the International Federation of Clinical Chemistry. Blood samples from each patient were collected in the morning after fasting, with glycosylated hemoglobin level measurements taken one week before and again at the end of the 12-week period.
Berg Balance Scale
Time frame: From enrollment to the end of treatment at 12 weeks.
The Berg Balance Scale is a 14-item scale that quantitatively evaluates balance and fall risk. Performance is directly observed. Scores of 0 to 20 represent a lack of balance, 21 to 40 indicate acceptable balance and 41 to 56 show good balance. This scale can be used to evaluate both static and dynamic balance
Yesavage Geriatric Depression Scale
Time frame: From enrollment to the end of treatment at 12 weeks.
The scale developed by Yesavage et al., consists of 30 questions and is used as a basic screening criterion for major and minor depression. Data obtained using the Yesavage Geriatric Depression Scale were categorized as follows: 'no depression' for individuals with a score below 11; 'probable depression' for individuals with a score between 12 and 14; and 'depression' for individuals with a score of 14 or above
Type 2 Diabetes Self-Management Scale
Time frame: From enrollment to the end of treatment at 12 weeks
The scale allows for individualized assessments of lifestyle, blood glucose management and healthcare utilisation in people with type 2 Diabetes. The scale consists of 19 items across three dimensions. The healthy lifestyle behaviours subscale contains 11 items; the blood glucose management subscale contains four items; and the utilizing health services subscale contains four items
Elderly Diabetes Burden Scale
Time frame: From enrollment to the end of treatment at 12 weeks.
Araki et al. developed the scale for assessing diabetic-specific psychological aspects with 6 subscales (symptom burden, dietary restrictions, social burden, worry about diabetes, treatment dissatisfaction, and burden by tablets or insulin). The total score range for this scale is 18-88. Validity and reliability in Turkish were examined by Usta and Esen in 2012. An increase in scale scores indicates an increase in the burden in that area, and a decrease in scores indicates a low burden in that area. The Cronbach alpha coefficient for the scale was found to be 0.92
30 Seconds Sit to Stand Test
Time frame: From enrollment to the end of treatment at 12 weeks.
In the study, the 30 second sit-stand test was used, which evaluates lower body strength and endurance in older adults. Protocol developed by Rikli and Jones to determine the physical fitness levels of older adults between the ages of 60-94. The patient is asked to sit and then stand unaided for 30 seconds, and performing less than 8 repetitions is a risk indicator
Timed Up&Go Test
Time frame: From enrollment to the end of treatment at 12 weeks.
The Timed Up\&Go Test includes independent measures of mobility and functional ability, including standing up from a chair, walking, turning, stopping, and sitting again. The person is asked to get up from the chair they are sitting in, walk 3 meters, come back and sit on the chair again, and the elapsed time is recorded
Gait speed measurement
Time frame: From enrollment to the end of treatment at 12 weeks.
Participants were asked to walk along a 4-metre track at their normal speed. This is an effective way of determining a person's physical function. Those who generally walk faster than 1 m/s tend to have a better functional status, a lower risk of health problems, and a higher survival rate
Hand Grip Strength
Time frame: From enrollment to the end of treatment at 12 weeks.
Muscle strength was evaluated through handgrip measurements using a handheld dynamometer (TKK 5001. Grip-A; Takei. Tokyo. Japan). Each participant completed three maximal grip trials with the left hand, followed by three with the right, with 1-min rest intervals between attempts. The test is a determinant of age-related decline in physical function
Strength of Upper/Lower Limbs
Time frame: From enrollment to the end of treatment at 12 weeks.
The handheld dynamometer (HHD), which measures isometric muscle strength, is a simple to use, easy to carry, inexpensive and light device. Quadriceps femoris, hamstring, tibialis anterior, iliopsoas, gluteus medius, biceps brachii, and shoulder abductor muscles evaluated with a handheld dynamometer
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 10 Sep 2025.
- Individual participant dataSharing planned: No. It will be added to the university's library and researchers can reach If they login to library's webpage. https://kutuphane.karatekin.edu.tr/.
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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.
Huri Seval Gönderen Çakmak, Phd study director
Çankırı Karatekin 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 Interdisciplinary group, Clinical Pilates Group and Nurse Coaching group in people with Type 2 Diabetes, 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?
The sponsor lists 7 inclusion and 2 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 10 Sep 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?
Geriatric Anxiety Inventory (time frame: From enrollment to the end of treatment at 12 weeks.). The study lists 11 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 10 Sep 2025.