Diabetes Mellitus, Type 2NCT05691738
Effects of Modified Otago Exercises in Individuals With Diabetic Neuropathy
A study testing Exercise Group in people with Diabetes Mellitus, Type 2 and Neuropathy, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the effects of modified otago exercises on joint position sense, balance and physical fitness parameters in individuals with diabetic neuropathy. In addition aim of to examine the effects of exercise on metabolic variables and to gain exercise awareness in diabetic individuals. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Neuropathy
- What is being tested?
- Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 31 Dec 2023
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with Neuropathy Diagnosed with Type 2 Diabetes between the Ages of 40-65 Years
- Cooperative, able to take instructions (Mini Mental Test score of 24 and above)
- Able to walk independently
- With a Body Mass Index Below 40 Kg/M2
- Not Doing Regular Physical Activity for the Last 6 Months
- Voluntarily participated in the research
Who cannot join
- Additional neurological problem other than neuropathy
- Any orthopedic or systemic problems that will prevent him from performing the exercises
- The presence of pathology related to the lower limb that occurred within the last 6 months (surgery, fracture, soft tissue injuries, etc.)
- Pregnant
- Vision problem that cannot be corrected with glasses or lenses
- Hearing loss that cannot be corrected with hearing aids
Show all 9Show fewer
- Foot ulcer
- Patients who have been diagnosed with cancer and are receiving chemotherapy in this context
- With limitation of the range of motion of the joints of the lower extremities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Provincial Health Directorate Karaman Training and Research Hospital
Karaman, Center, 70200
About this study
Official title: The Effect of Modified Otago Exercises on Metabolic Parameters, Joint Position Sense, Balance and Health-Related Physical Fitness Parameters in Individuals With Diabetic Neuropathy
The aim of the study is to investigate the effects of modified otago exercises on joint position sense, balance and physical fitness parameters in individuals with diabetic neuropathy. In addition aim of to examine the effects of exercise on metabolic variables and to gain exercise awareness in diabetic individuals.
- Conditions
- Diabetes Mellitus, Type 2, Neuropathy
- Being tested
- Exercise Group, Control Group
- Keywords
- Otago Exercise, Joint Position Sense, Balance, Physical Fitness
- 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.
Exercise GroupOther
The exercise group will be informed about diabetes and diabetes complications. A total of 16 sessions of 8 weeks, modified otago exercises will be applied individually by the research physiotherapist.Individuals will be allowed to walk at a moderate pace for at least 30 minutes 5 days a week (home program).
Control GroupOther
The control group will be informed about diabetes and diabetes complications. Individuals will be allowed to walk at a moderate pace for at least 30 minutes 5 days a week (home program)
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Information will be given about diabetes and its complications.Modified Otago Exercise will be applied by the physiotherapist.Participants will be given a home program Receives: Other: Exercise Group |
| Control Group | Other | Information will be given about diabetes and its complications.Participants will be given a home program Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Level
Routinely, the glycated hemoglobin (Hba1c) (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Measured: Change from baseline at 8 weeks
Blood Cholesterol Level
Routinely, the cholesterol (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Measured: Change from baseline at 8 weeks
Blood Triglycerides Level
Routinely, the triglycerides (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Measured: Change from baseline at 8 weeks
Blood HDL Cholesterol Level
Routinely, the HDL cholesterol (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Measured: Change from baseline at 8 weeks
Blood LDL Cholesterol Level
Routinely, the LDL cholesterol (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Measured: Change from baseline at 8 weeks
Joint Position Sense Evaluation
Ankle joint position sense of 10 degrees dorsiflexion and 15 degrees plantar flexion target angles will be evaluated.
Measured: Change from baseline at 8 weeks
The Timed Up & Go (Functional Mobility Assessment)
Patients sitting in a chair without armrests will be asked to stand up with the start command and walk the 3-meter distance, whose start and end points are specified before, turn around and sit on the chair again. The test will be repeated 3 times and the average time will be recorded.
Measured: Change from baseline at 8 weeks
Balance Evaluation
Balance Error Scoring System:Practices are performed on hard and soft ground separately in 3 positions, two feet, one foot and tandem stance, with eyes closed.After the test position is taught to the patient, the patient is asked to close their eyes and hold the position for 20 seconds.A mistake made for 20 seconds on each floor and position is recorded as 1 point.The maximum error score is 10.All assessments are made without shoes
Measured: Change from baseline at 8 weeks
Body Mass İndex Evaluation
Body weight of the individual is recorded in kilograms and height in meters.Calculated by dividing body weight by the square of the height in meters (kg/m2)
Measured: Change from baseline at 8 weeks
Body Weight
Calculated in kilograms (kg) with a Tanita BC730 brand scale
Measured: Change from baseline at 8 weeks
Body Fat Percentage
Body fat percentage is calculated as percentage (%) with Tanita BC730 brand scale
Measured: Change from baseline at 8 weeks
Lean Body Weight
Calculated in kilograms (kg) by subtracting body fat from body weight.
Measured: Change from baseline at 8 weeks
Cardio-respiratory Fitness Evaluation
A distance of 30 meters is created in an area measuring 10x40 meters, the start and end points are marked.Patients are asked to walk on the designated line for 6 minutes at the highest speed they can walk without running.At the end of 6 minutes, the distance they have walked is recorded in meters.
Measured: Change from baseline at 8 weeks
Sit and Reach Test (Flexibility ) Evaluation
The patient is asked to lie down without bending his knees towards the ruler placed on the flexibility table. Before the test, the patient is asked to reach forward 1-2 times and is taught what to do. Then the patient is asked to lie forward 3 times and the average of the data obtained is recorded in centimeters.
Measured: Change from baseline at 8 weeks
Muscle Strength (30-second Chair Stand Test) Evaluation
Sitting in a standard chair without armrests, the patient is asked to cross his hands over his shoulder. With the start command, the stopwatch is kept and the patient is asked to stand up completely from the chair and sit down again. The number of repetitive movements for 30 seconds is recorded.
Measured: Change from baseline at 8 weeks
Falling Risk
Fall Efficacy Scale International: It is a common test battery with 16 items that reveals the possibility of falling in patients.The higher the test score, the higher the probability of falling in the patient.
Measured: Change from baseline at 8 weeks
Secondary outcomes (5)
Cognitive Status
Mini Mental Test will be used to evaluate the cognitive status of individuals. It is a short, useful, standardized test that provides the opportunity to evaluate cognitive performance in a short time. A high score indicates a good cognitive status. The maximum possible score is 30. A score of 17 and below is considered severe dementia, a score of 18-23 is considered mild dementia, and a score of 24-30 is considered normal.
Measured: a day before the start of treatment
Neuropathic Pain Scale
Self-Leeds Assesment of Neuropathic Symptoms \& Signs Pain Score: It is a simple test used in the differential diagnosis of neuropathic pain at the bedside.A score of 12 and above is diagnostic for neuropathic pain
Measured: Change from baseline at 8 weeks
Individual Exercise İntensity
Borg Scale: It is a method used to determine the exercise tolerance of the individual.The individual scores the fatigue she feels between 6-20.Fatigue level; nothing (6), very very light (7-8), very light (9-10), light (11-12), somewhat difficult (13-14), difficult (15-16), very difficult (17- 18), very very difficult (19), exhaustion (20)
Measured: a day before the start of treatment
Monofilament Evaluation
The monofilament is touched to the relevant point on the foot until it takes a C shape. Absence of a 4.17 or thicker monofilament is interpreted as being compatible with neuropathy.Failure to detect a 5.07 monofilament is considered as a loss of protective sensation.
Measured: a day before the start of treatment
Diaposan (Vibration) Evaluation
A 128 Hz tuning fork, which was oscillated before, is placed on the metatarsophalangeal joint of both feet of the individual and the patient is asked to feel the vibration. If the investigator still perceives the vibration as soon as the patient says he does not feel the vibration, it is considered neuropathy.
Measured: a day before the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Responsible party
- Principal investigator, Ali CEYLAN, Karamanoğlu Mehmetbey University
- Investigators
- ALİ CEYLAN, MSc, Principal investigator, Karamanoğlu Mehmetbey UniversityErtuğrul DEMİRDEL, PhD, Study chair, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691738
- Sponsor's protocol ID
- KMU-ACEYLAN-001
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2022
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Modified Otago Exercises on Metabolic Parameters, Joint Position Sense, Balance and Health-Related Physical Fitness Parameters in Individuals With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05691738
- Acronym / sponsor ID
- KMU-ACEYLAN-001
- Conditions
- Diabetes Mellitus, Type 2, Neuropathy
- Keywords
- Otago Exercise, Joint Position Sense, Balance, Physical Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Jan 2023 (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 is to investigate the effects of modified otago exercises on joint position sense, balance and physical fitness parameters in individuals with diabetic neuropathy. In addition aim of to examine the effects of exercise on metabolic variables and to gain exercise awareness in diabetic individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Exercise GroupInformation will be given about diabetes and its complications.Modified Otago Exercise will be applied by the physiotherapist.Participants will be given a home program |
| Control Group | Other | Other: Control GroupInformation will be given about diabetes and its complications.Participants will be given a home program |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals with Neuropathy Diagnosed with Type 2 Diabetes between the Ages of 40-65 Years
- Cooperative, able to take instructions (Mini Mental Test score of 24 and above)
- Able to walk independently
- With a Body Mass Index Below 40 Kg/M2
- Not Doing Regular Physical Activity for the Last 6 Months
Key exclusion criteria (9 listed)
- Additional neurological problem other than neuropathy
- Any orthopedic or systemic problems that will prevent him from performing the exercises
- The presence of pathology related to the lower limb that occurred within the last 6 months (surgery, fracture, soft tissue injuries, etc.)
- Pregnant
- Vision problem that cannot be corrected with glasses or lenses
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 |
|---|---|---|
| Exercise GroupThe exercise group will be informed about diabetes and diabetes complications. A total of 16 sessions of 8 weeks, modified otago exercises will be applied individually by the research physiotherapist.Individuals will be allowed to walk at a moderate pace for at least 30 minutes 5 days a week (home program). | Other | Exercise Group |
| Control GroupThe control group will be informed about diabetes and diabetes complications. Individuals will be allowed to walk at a moderate pace for at least 30 minutes 5 days a week (home program) | Other | Control Group |
Primary outcome
Blood Glucose Level
Time frame: Change from baseline at 8 weeks
Routinely, the glycated hemoglobin (Hba1c) (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Blood Cholesterol Level
Time frame: Change from baseline at 8 weeks
Routinely, the cholesterol (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Blood Triglycerides Level
Time frame: Change from baseline at 8 weeks
Routinely, the triglycerides (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Blood HDL Cholesterol Level
Time frame: Change from baseline at 8 weeks
Routinely, the HDL cholesterol (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Blood LDL Cholesterol Level
Time frame: Change from baseline at 8 weeks
Routinely, the LDL cholesterol (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Joint Position Sense Evaluation
Time frame: Change from baseline at 8 weeks
Ankle joint position sense of 10 degrees dorsiflexion and 15 degrees plantar flexion target angles will be evaluated.
The Timed Up & Go (Functional Mobility Assessment)
Time frame: Change from baseline at 8 weeks
Patients sitting in a chair without armrests will be asked to stand up with the start command and walk the 3-meter distance, whose start and end points are specified before, turn around and sit on the chair again. The test will be repeated 3 times and the average time will be recorded.
Balance Evaluation
Time frame: Change from baseline at 8 weeks
Balance Error Scoring System:Practices are performed on hard and soft ground separately in 3 positions, two feet, one foot and tandem stance, with eyes closed.After the test position is taught to the patient, the patient is asked to close their eyes and hold the position for 20 seconds.A mistake made for 20 seconds on each floor and position is recorded as 1 point.The maximum error score is 10.All assessments are made without shoes
Body Mass İndex Evaluation
Time frame: Change from baseline at 8 weeks
Body weight of the individual is recorded in kilograms and height in meters.Calculated by dividing body weight by the square of the height in meters (kg/m2)
Body Weight
Time frame: Change from baseline at 8 weeks
Calculated in kilograms (kg) with a Tanita BC730 brand scale
Body Fat Percentage
Time frame: Change from baseline at 8 weeks
Body fat percentage is calculated as percentage (%) with Tanita BC730 brand scale
Lean Body Weight
Time frame: Change from baseline at 8 weeks
Calculated in kilograms (kg) by subtracting body fat from body weight.
Cardio-respiratory Fitness Evaluation
Time frame: Change from baseline at 8 weeks
A distance of 30 meters is created in an area measuring 10x40 meters, the start and end points are marked.Patients are asked to walk on the designated line for 6 minutes at the highest speed they can walk without running.At the end of 6 minutes, the distance they have walked is recorded in meters.
Sit and Reach Test (Flexibility ) Evaluation
Time frame: Change from baseline at 8 weeks
The patient is asked to lie down without bending his knees towards the ruler placed on the flexibility table. Before the test, the patient is asked to reach forward 1-2 times and is taught what to do. Then the patient is asked to lie forward 3 times and the average of the data obtained is recorded in centimeters.
Muscle Strength (30-second Chair Stand Test) Evaluation
Time frame: Change from baseline at 8 weeks
Sitting in a standard chair without armrests, the patient is asked to cross his hands over his shoulder. With the start command, the stopwatch is kept and the patient is asked to stand up completely from the chair and sit down again. The number of repetitive movements for 30 seconds is recorded.
Falling Risk
Time frame: Change from baseline at 8 weeks
Fall Efficacy Scale International: It is a common test battery with 16 items that reveals the possibility of falling in patients.The higher the test score, the higher the probability of falling in the patient.
5 secondary outcomes
Cognitive Status
Time frame: a day before the start of treatment
Neuropathic Pain Scale
Time frame: Change from baseline at 8 weeks
Individual Exercise İntensity
Time frame: a day before the start of treatment
Monofilament Evaluation
Time frame: a day before the start of treatment
Diaposan (Vibration) Evaluation
Time frame: a day before the start of 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 27 Apr 2026.
- Individual participant dataSharing planned: No
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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.
ALİ CEYLAN, MSc principal investigator
Karamanoğlu Mehmetbey University
Ertuğrul DEMİRDEL, PhD study chair
Ankara Yildirim Beyazıt 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 Exercise Group in people with Diabetes Mellitus, Type 2 and Neuropathy, run by Karamanoğlu Mehmetbey 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 9 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 27 Apr 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?
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?
Blood Glucose Level (time frame: Change from baseline at 8 weeks). The study lists 16 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 27 Apr 2026.