Effects of Modified Otago Exercises in Individuals With Diabetic Neuropathy

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Neuropathy
• Intervention / Treatment: Other: Exercise Group; Other: Control Group

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Center
    • Karaman, Center, Turkey (Türkiye), 70200
      • Karaman Provincial Health Directorate Karaman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group; 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; 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).
Other: Control Group; Information will be given about diabetes and its complications.Participants will be given a home program	Other: Control Group; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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)	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.	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.	a day before the start of treatment

Collaborators and Investigators

• Sponsor: Karamanoğlu Mehmetbey University
• Collaborators: Ankara Yildirim Beyazıt University
• Investigators: Principal Investigator: ALİ CEYLAN, MSc, Karamanoglu Mehmetbey University; Study Chair: Ertuğrul DEMİRDEL, PhD, Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Balance; Physical Fitness; Otago Exercise; Joint Position Sense
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: KMU-ACEYLAN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No