Effects of Modified Otago Exercises in Individuals With Diabetic Neuropathy

NCT05691738 | Completed

• 1 other identifier: KMU-ACEYLAN-001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Neuropathy

Keywords

Otago Exercise; Joint Position Sense; Balance; Physical Fitness

Outcome Measures

Primary Outcomes (16)

• Blood Glucose Level

  Routinely, the glycated hemoglobin (Hba1c) (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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)

  Change from baseline at 8 weeks

• Body Weight

  Calculated in kilograms (kg) with a Tanita BC730 brand scale

  Change from baseline at 8 weeks

• Body Fat Percentage

  Body fat percentage is calculated as percentage (%) with Tanita BC730 brand scale

  Change from baseline at 8 weeks

• Lean Body Weight

  Calculated in kilograms (kg) by subtracting body fat from body weight.

  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.

  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.

  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.

  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.

  Change from baseline at 8 weeks

Secondary Outcomes (5)

• Cognitive Status

  a day before the start of treatment

• Neuropathic Pain Scale

  Change from baseline at 8 weeks

• Individual Exercise İntensity

  a day before the start of treatment

• Monofilament Evaluation

  a day before the start of treatment

• Diaposan (Vibration) Evaluation

  a day before the start of treatment

Study Arms (2)

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

Other: Exercise Group

Control Group

OTHER

Information will be given about diabetes and its complications.Participants will be given a home program

Other: Control Group

Interventions

Exercise Group OTHER

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).

Exercise Group

Control Group OTHER

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)

Control Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead
• Ankara Yildirim Beyazıt University: collaborator

Study Sites (1)

Karaman Provincial Health Directorate Karaman Training and Research Hospital

Karaman, Center, 70200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• ALİ CEYLAN, MSc

  Karamanoğlu Mehmetbey University

  PRINCIPAL INVESTIGATOR

• Ertuğrul DEMİRDEL, PhD

  Ankara Yildirim Beyazıt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The physician who will evaluate the metabolic parametres will not know which arm the individual is in. İn addition, the participants will not know which arm they are in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 20, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)