Effects of Modified Otago Exercises in Individuals With Diabetic Neuropathy

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05691738
• Other study ID #: KMU-ACEYLAN-001
• Status: Completed
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Karamanoglu Mehmetbey University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Neuropathies
• Neuropathy

Intervention

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).
• 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)

Locations

Country	Name	City	State
Turkey	Karaman Provincial Health Directorate Karaman Training and Research Hospital	Karaman	Center

Sponsors (2)

Lead Sponsor	Collaborator
Karamanoglu Mehmetbey University	Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Joint Position Sense Evaluation	Target angles for knee joint joint position sense will be determined as 30 and 60 degrees of knee flexion. Ankle joint position sense of 10 degrees dorsiflexion and 15 degrees plantar flexion target angles will be evaluated.	Change from baseline at 8 weeks
Primary	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
Primary	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
Primary	Body Mass Index 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
Primary	Body Weight	Calculated in kilograms (kg) with a Tanita BC730 brand scale	Change from baseline at 8 weeks
Primary	Body Fat Percentage	Body fat percentage is calculated as percentage (%) with Tanita BC730 brand scale	Change from baseline at 8 weeks
Primary	Lean Body Weight	Calculated in kilograms (kg) by subtracting body fat from body weight.	Change from baseline at 8 weeks
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Individual Exercise Intensity	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
Secondary	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
Secondary	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