Back to resultsEffects of Modified Otago Exercises in Individuals With Diabetic Neuropathy
Primary Purpose
Diabetes Mellitus, Type 2, Neuropathy
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise Group
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Otago Exercise, Joint Position Sense, Balance, Physical Fitness
Eligibility Criteria
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
Sites / Locations
- Karaman Provincial Health Directorate Karaman Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Exercise Group
Control Group
Arm Description
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
Information will be given about diabetes and its complications.Participants will be given a home program
Outcomes
Primary Outcome Measures
Blood Glucose Level
Routinely, the glycated hemoglobin (Hba1c) (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Blood Cholesterol Level
Routinely, the cholesterol (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Blood Triglycerides Level
Routinely, the triglycerides (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Blood HDL Cholesterol Level
Routinely, the HDL cholesterol (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Blood LDL Cholesterol Level
Routinely, the LDL cholesterol (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
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.
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.
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
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)
Body Weight
Calculated in kilograms (kg) with a Tanita BC730 brand scale
Body Fat Percentage
Body fat percentage is calculated as percentage (%) with Tanita BC730 brand scale
Lean Body Weight
Calculated in kilograms (kg) by subtracting body fat from body weight.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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
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)
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.
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.
Full Information
NCT ID
NCT05691738
First Posted
December 23, 2022
Last Updated
January 10, 2023
Sponsor
Karamanoğlu Mehmetbey University
Collaborators
Ankara Yildirim Beyazıt University
1. Study Identification
Unique Protocol Identification Number
NCT05691738
Brief Title
Effects of Modified Otago Exercises in Individuals With Diabetic Neuropathy
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karamanoğlu Mehmetbey University
Collaborators
Ankara Yildirim Beyazıt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Neuropathy
Keywords
Otago Exercise, Joint Position Sense, Balance, Physical Fitness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Other
Arm Description
Information will be given about diabetes and its complications.Participants will be given a home program
Intervention Type
Other
Intervention Name(s)
Exercise Group
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
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)
Primary Outcome Measure Information:
Title
Blood Glucose Level
Description
Routinely, the glycated hemoglobin (Hba1c) (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Time Frame
Change from baseline at 8 weeks
Title
Blood Cholesterol Level
Description
Routinely, the cholesterol (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Time Frame
Change from baseline at 8 weeks
Title
Blood Triglycerides Level
Description
Routinely, the triglycerides (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Time Frame
Change from baseline at 8 weeks
Title
Blood HDL Cholesterol Level
Description
Routinely, the HDL cholesterol (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Time Frame
Change from baseline at 8 weeks
Title
Blood LDL Cholesterol Level
Description
Routinely, the LDL cholesterol (mg/dL) level will be recorded in the blood laboratory results by the endocrinologist.
Time Frame
Change from baseline at 8 weeks
Title
Joint Position Sense Evaluation
Description
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.
Time Frame
Change from baseline at 8 weeks
Title
The Timed Up & Go (Functional Mobility Assessment)
Description
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.
Time Frame
Change from baseline at 8 weeks
Title
Balance Evaluation
Description
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
Time Frame
Change from baseline at 8 weeks
Title
Body Mass İndex Evaluation
Description
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)
Time Frame
Change from baseline at 8 weeks
Title
Body Weight
Description
Calculated in kilograms (kg) with a Tanita BC730 brand scale
Time Frame
Change from baseline at 8 weeks
Title
Body Fat Percentage
Description
Body fat percentage is calculated as percentage (%) with Tanita BC730 brand scale
Time Frame
Change from baseline at 8 weeks
Title
Lean Body Weight
Description
Calculated in kilograms (kg) by subtracting body fat from body weight.
Time Frame
Change from baseline at 8 weeks
Title
Cardio-respiratory Fitness Evaluation
Description
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.
Time Frame
Change from baseline at 8 weeks
Title
Sit and Reach Test (Flexibility ) Evaluation
Description
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.
Time Frame
Change from baseline at 8 weeks
Title
Muscle Strength (30-second Chair Stand Test) Evaluation
Description
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.
Time Frame
Change from baseline at 8 weeks
Title
Falling Risk
Description
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.
Time Frame
Change from baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Cognitive Status
Description
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.
Time Frame
a day before the start of treatment
Title
Neuropathic Pain Scale
Description
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
Time Frame
Change from baseline at 8 weeks
Title
Individual Exercise İntensity
Description
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)
Time Frame
a day before the start of treatment
Title
Monofilament Evaluation
Description
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.
Time Frame
a day before the start of treatment
Title
Diaposan (Vibration) Evaluation
Description
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.
Time Frame
a day before the start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ALİ CEYLAN, MSc
Phone
+905357150520
Email
aliceylan8770@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ertuğrul DEMİRDEL, PhD
Phone
+905378223551
Email
ertudemirdel@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALİ CEYLAN, MSc
Organizational Affiliation
Karamanoğlu Mehmetbey University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ertuğrul DEMİRDEL, PhD
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Study Chair
Facility Information:
Facility Name
Karaman Provincial Health Directorate Karaman Training and Research Hospital
City
Karaman
State/Province
Center
ZIP/Postal Code
70200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALİ CEYLAN, MSc
Phone
+905357150520
Email
aliceylan8770@gmail.com
First Name & Middle Initial & Last Name & Degree
Ertuğrul DEMİRDEL, PhD
Phone
+905378223551
Email
ertudemirdel@yahoo.com
First Name & Middle Initial & Last Name & Degree
ALİ CEYLAN, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Modified Otago Exercises in Individuals With Diabetic Neuropathy
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