Diabete Type 2NCT07693296
Type 2 Diabetes Mellitus and Downhill Aerobic Exercise Training
A study testing Downhill Aerobic Walking Training, Level Aerobic Walking Training and Home exercise session in people with Diabete Type 2 and Aerobic Exercise, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare the effects of an 8-week supervised downhill walking training program, prescribed based on the 6-minute walk test, on functional capacity, peripheral muscle strength, and cardiovascular responses in individuals with type 2 diabetes mellitus, as compared to a level walking… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabete Type 2, Aerobic Exercise, Walking
- What is being tested?
- Downhill Aerobic Walking Training, Level Aerobic Walking Training and Home exercise session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with Type 2 diabetes mellitus according to the American Diabetes Association (ADA) diagnostic criteria
- Be able to walk independently and be physically capable of walking on a treadmill
- Have no acute cardiovascular, neurological, or orthopedic conditions that would prevent participation in the exercise program
- No major changes to antidiabetic or cardiometabolic treatments within the last 3 months
- To be under regular follow-up and in a stable clinical condition
- To have been informed about the study and to provide written informed consent
Who cannot join
- Patients with severe peripheral neuropathy or a lack of protective sensation
- Lower extremity amputation
- Diabetic foot ulcer or the presence of severe skin lesions that impair walking
- Proliferative diabetic retinopathy or advanced retinopathy that could pose a risk of complications during exercise
- Severe diabetic nephropathy (eGFR <30 mL/min/1.73 m² or macroalbuminuria >300 mg/g)
- Uncontrolled hypertension (systolic blood pressure >200 mmHg and/or diastolic blood pressure >110 mmHg)
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- Fasting blood glucose level >250 mg/dL with signs of ketosis
- Unstable angina pectoris, a history of myocardial infarction within the past 6 months, or a history of clinically significant severe arrhythmia
- Advanced heart failure (NYHA Class III-IV)
- Having a chronic respiratory disease
- Having participated in a regular exercise, sports, or physical therapy program within the past 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakıf University Dragos Hospital
Istanbul, Maltepe
Yasin Baki Baydaş, M.D., +90216 251 65 65, ybaydas@bezmialem.edu.tr
About this study
Official title: The Effect of Downhill Walking Training on Functional Capacity, Peripheral Muscle Strength, and Cardiovascular Responses in Individuals With Type 2 Diabetes Mellitus
The purpose of this study is to compare the effects of an 8-week supervised downhill walking training program, prescribed based on the 6-minute walk test, on functional capacity, peripheral muscle strength, and cardiovascular responses in individuals with type 2 diabetes mellitus, as compared to a level walking training program.
Participants who agree to take part in the study will be randomly assigned to either the downhill or the level-ground walking group. Both groups will undergo a 6-minute walk test (6MWT) at the beginning of the study, and participants will then undergo an 8-week walking training program-conducted twice a week on a treadmill under the supervision of a physical therapist-in which their walking speed is determined based on their average speed during the 6MWT and gradually increased, with the duration of the sessions also being extended.
Read more
Participants will do the following:
- They will participate in walking training sessions at a center twice a week for 8 weeks, under the supervision of a physical therapist.
- Once a week for 8 weeks, they will walk the same distance they walked with their supervisor that week as a homework assignment.
- They will come to the facility where they conducted their exercise sessions for evaluations at the beginning of the program and after the 8th week.
- Conditions
- Diabete Type 2, Aerobic Exercise, Walking
- Being tested
- Downhill Aerobic Walking Training, Level Aerobic Walking Training, Home exercise session
- 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.
Downhill Aerobic Walking TrainingOther
This involves performing a progressive aerobic exercise program-prescribed based on the results of a 6-minute walk test-twice a week for 8 weeks, at a constant 10-degree downhill, under the supervision of a physical therapist.
Level Aerobic Walking TrainingOther
This involves performing a progressive aerobic exercise program-prescribed based on the results of a 6-minute walk test-twice a week for 8 weeks, at a constant 0-degree (i.e., level) slope, under the supervision of a physical therapist.
Home exercise sessionOther
It involves assigning the distance walked during that week's exercise session-conducted under the supervision of a physical therapist-as homework to be walked at home on one day of the same week.
| Study group | Role | What they receive |
|---|---|---|
| Downhill Walking | Experimental | Not described Receives: Other: Downhill Aerobic Walking Training; Other: Home exercise session |
| Level Walking | Active comparator | Not described Receives: Other: Level Aerobic Walking Training; Other: Home exercise session |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test (6MWT)
The 6DYT is a walking test used to assess a participant's submaximal exercise capacity, during which the participant walks for six minutes at a self-determined pace. The patient walks as far as possible along a 30-meter corridor for six minutes. The total distance walked during the test will be recorded in meters as the primary outcome measure.
Measured: From baseline to the end of treatment at 8 weeks
Measurement of Peripheral Muscle Strength
Muscle strength measurements for hip extension, knee extension, knee flexion, and ankle plantar flexion will be performed using a handheld dynamometer. A dynamometer is a device that enables more quantitative measurements; the person conducting the test holds it in their hand to perform manual muscle testing. Different body segments have different pads. The muscles will be properly positioned and assessed. For each muscle group, measurements will be performed 3 to 5 times on both the right and left extremities, and the peak force will be recorded for each muscle group. Results will be recorded in Newtons.
Measured: From baseline to the end of treatment at 8 weeks
Heart Rate Variability (HRV) - Root Mean Square of Successive Differences (RMSSD)
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The RMSSD values will be recorded in milliseconds (ms) as a key indicator of parasympathetic activity.
Measured: From baseline to the end of treatment at 8 weeks
Heart Rate Variability (HRV) - Standard Deviation of NN Intervals (SDNN)
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The SDNN values will be recorded in milliseconds (ms) to reflect overall autonomic variability.
Measured: From baseline to the end of treatment at 8 weeks
Heart Rate Variability (HRV) - Mean RR Interval
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The Mean RR values will be recorded in milliseconds (ms) to indicate the average time between heartbeats.
Measured: From baseline to the end of treatment at 8 weeks
Heart Rate Variability (HRV) - LF/HF Ratio
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The LF/HF ratio will be recorded as a dimensionless value summarizing the sympathovagal balance.
Measured: From baseline to the end of treatment at 8 weeks
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale is a 9-item measure that assesses the severity of fatigue and how it affects a person's activities. Participants respond to each item on a Likert scale ranging from 1: "I strongly disagree" to 7: "I strongly agree." The total score on the scale ranges from a minimum of 9 to a maximum of 63. Higher scores indicate more severe fatigue and greater impairment. The use of this scale is recommended for assessing fatigue in patients with type 2 diabetes.
Measured: From baseline to the end of treatment at 8 weeks
Blood Test Results: Glycated Hemoglobin (HbA1c)
HbA1c levels will be measured to assess participants' long-term glycemic control and the metabolic effects of the exercise training. The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods. Results will be reported as a percentage (%).
Measured: From baseline to the end of treatment at 8 weeks
Blood Test Results: Fasting Blood Glucose (FBG)
Fasting blood glucose levels will be measured to assess participants' current metabolic status. The blood sample will be ordered by the attending physician after an overnight fast and analyzed using standard laboratory methods. Results will be reported in milligrams per deciliter (mg/dL).
Measured: From baseline to the end of treatment at 8 weeks
Lipid Profile: Low-Density Lipoprotein (LDL) Cholesterol
LDL cholesterol levels will be measured for the purposes of cardiovascular risk management and monitoring metabolic adaptation. The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods. Results will be reported in milligrams per deciliter (mg/dL).
Measured: From baseline to the end of treatment at 8 weeks
Lipid Profile: High-Density Lipoprotein (HDL) Cholesterol
HDL cholesterol levels will be measured for the purposes of cardiovascular risk management and monitoring metabolic adaptation. The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods. Results will be reported in milligrams per deciliter (mg/dL).
Measured: From baseline to the end of treatment at 8 weeks
Lipid Profile: Triglycerides
Triglyceride levels will be measured for the purposes of cardiovascular risk management and monitoring metabolic adaptation. The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods. Results will be reported in milligrams per deciliter (mg/dL).
Measured: From baseline to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Apr 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Acibadem 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Principal investigator, Meryem BEKTAŞ KARAKUŞ, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693296
- Sponsor's protocol ID
- 2026-06/254
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Downhill Walking Training on Functional Capacity, Peripheral Muscle Strength, and Cardiovascular Responses in Individuals With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07693296
- Acronym / sponsor ID
- 2026-06/254
- Conditions
- Diabete Type 2, Aerobic Exercise, Walking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 9 Jul 2026 (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 purpose of this study is to compare the effects of an 8-week supervised downhill walking training program, prescribed based on the 6-minute walk test, on functional capacity, peripheral muscle strength, and cardiovascular responses in individuals with type 2 diabetes mellitus, as compared to a level walking training program.
Participants who agree to take part in the study will be randomly assigned to either the downhill or the level-ground walking group. Both groups will undergo a 6-minute walk test (6MWT) at the beginning of the study, and participants will then undergo an 8-week walking training program-conducted twice a week on a treadmill under the supervision of a physical therapist-in which their walking speed is determined based on their average speed during the 6MWT and gradually increased, with the duration of the sessions also being extended.
Participants will do the following:
- They will participate in walking training sessions at a center twice a week for 8 weeks, under the supervision of a physical therapist.
- Once a week for 8 weeks, they will walk the same distance they walked with their supervisor that week as a homework assignment.
- They will come to the facility where they conducted their exercise sessions for evaluations at the beginning of the program and after the 8th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Downhill Walking | Experimental | Other: Downhill Aerobic Walking Training, Other: Home exercise session |
| Level Walking | Active comparator | Other: Level Aerobic Walking Training, Other: Home exercise session |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have been diagnosed with Type 2 diabetes mellitus according to the American Diabetes Association (ADA) diagnostic criteria
- Be able to walk independently and be physically capable of walking on a treadmill
- Have no acute cardiovascular, neurological, or orthopedic conditions that would prevent participation in the exercise program
- No major changes to antidiabetic or cardiometabolic treatments within the last 3 months
- To be under regular follow-up and in a stable clinical condition
Key exclusion criteria (11 listed)
- Patients with severe peripheral neuropathy or a lack of protective sensation
- Lower extremity amputation
- Diabetic foot ulcer or the presence of severe skin lesions that impair walking
- Proliferative diabetic retinopathy or advanced retinopathy that could pose a risk of complications during exercise
- Severe diabetic nephropathy (eGFR <30 mL/min/1.73 m² or macroalbuminuria >300 mg/g)
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 |
|---|---|---|
| Downhill Aerobic Walking TrainingThis involves performing a progressive aerobic exercise program-prescribed based on the results of a 6-minute walk test-twice a week for 8 weeks, at a constant 10-degree downhill, under the supervision of a physical therapist. | Other | Downhill Walking |
| Level Aerobic Walking TrainingThis involves performing a progressive aerobic exercise program-prescribed based on the results of a 6-minute walk test-twice a week for 8 weeks, at a constant 0-degree (i.e., level) slope, under the supervision of a physical therapist. | Other | Level Walking |
| Home exercise sessionIt involves assigning the distance walked during that week's exercise session-conducted under the supervision of a physical therapist-as homework to be walked at home on one day of the same week. | Other | Downhill Walking, Level Walking |
Primary outcome
6-Minute Walk Test (6MWT)
Time frame: From baseline to the end of treatment at 8 weeks
The 6DYT is a walking test used to assess a participant's submaximal exercise capacity, during which the participant walks for six minutes at a self-determined pace. The patient walks as far as possible along a 30-meter corridor for six minutes. The total distance walked during the test will be recorded in meters as the primary outcome measure.
Measurement of Peripheral Muscle Strength
Time frame: From baseline to the end of treatment at 8 weeks
Muscle strength measurements for hip extension, knee extension, knee flexion, and ankle plantar flexion will be performed using a handheld dynamometer. A dynamometer is a device that enables more quantitative measurements; the person conducting the test holds it in their hand to perform manual muscle testing. Different body segments have different pads. The muscles will be properly positioned and assessed. For each muscle group, measurements will be performed 3 to 5 times on both the right and left extremities, and the peak force will be recorded for each muscle group. Results will be recorded in Newtons.
Heart Rate Variability (HRV) - Root Mean Square of Successive Differences (RMSSD)
Time frame: From baseline to the end of treatment at 8 weeks
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The RMSSD values will be recorded in milliseconds (ms) as a key indicator of parasympathetic activity.
Heart Rate Variability (HRV) - Standard Deviation of NN Intervals (SDNN)
Time frame: From baseline to the end of treatment at 8 weeks
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The SDNN values will be recorded in milliseconds (ms) to reflect overall autonomic variability.
Heart Rate Variability (HRV) - Mean RR Interval
Time frame: From baseline to the end of treatment at 8 weeks
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The Mean RR values will be recorded in milliseconds (ms) to indicate the average time between heartbeats.
Heart Rate Variability (HRV) - LF/HF Ratio
Time frame: From baseline to the end of treatment at 8 weeks
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The LF/HF ratio will be recorded as a dimensionless value summarizing the sympathovagal balance.
Fatigue Severity Scale (FSS)
Time frame: From baseline to the end of treatment at 8 weeks
The Fatigue Severity Scale is a 9-item measure that assesses the severity of fatigue and how it affects a person's activities. Participants respond to each item on a Likert scale ranging from 1: "I strongly disagree" to 7: "I strongly agree." The total score on the scale ranges from a minimum of 9 to a maximum of 63. Higher scores indicate more severe fatigue and greater impairment. The use of this scale is recommended for assessing fatigue in patients with type 2 diabetes.
Blood Test Results: Glycated Hemoglobin (HbA1c)
Time frame: From baseline to the end of treatment at 8 weeks
HbA1c levels will be measured to assess participants' long-term glycemic control and the metabolic effects of the exercise training. The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods. Results will be reported as a percentage (%).
Blood Test Results: Fasting Blood Glucose (FBG)
Time frame: From baseline to the end of treatment at 8 weeks
Fasting blood glucose levels will be measured to assess participants' current metabolic status. The blood sample will be ordered by the attending physician after an overnight fast and analyzed using standard laboratory methods. Results will be reported in milligrams per deciliter (mg/dL).
Lipid Profile: Low-Density Lipoprotein (LDL) Cholesterol
Time frame: From baseline to the end of treatment at 8 weeks
LDL cholesterol levels will be measured for the purposes of cardiovascular risk management and monitoring metabolic adaptation. The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods. Results will be reported in milligrams per deciliter (mg/dL).
Lipid Profile: High-Density Lipoprotein (HDL) Cholesterol
Time frame: From baseline to the end of treatment at 8 weeks
HDL cholesterol levels will be measured for the purposes of cardiovascular risk management and monitoring metabolic adaptation. The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods. Results will be reported in milligrams per deciliter (mg/dL).
Lipid Profile: Triglycerides
Time frame: From baseline to the end of treatment at 8 weeks
Triglyceride levels will be measured for the purposes of cardiovascular risk management and monitoring metabolic adaptation. The blood sample will be ordered by the attending physician and analyzed using standard laboratory methods. Results will be reported in milligrams per deciliter (mg/dL).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Downhill Aerobic Walking Training, Level Aerobic Walking Training and Home exercise session in people with Diabete Type 2 and Aerobic Exercise, run by Acibadem 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meryem Bektaş Karakuş (+90216 500 41 95, meryem.bektas@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walk Test (6MWT) (time frame: From baseline to the end of treatment at 8 weeks). The study lists 12 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 9 Jul 2026.