The Effect of Modified Otago Exercises on Metabolic Parameters, Joint Position Sense, Balance and Health-Related Physical Fitness Parameters in Individuals With Diabetic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Blood Glucose Level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
- •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
研究组 & 干预措施
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
干预措施: Exercise Group (Other)
Control Group
Information will be given about diabetes and its complications.Participants will be given a home program
干预措施: Control Group (Other)
结局指标
主要结局
Blood Glucose Level
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
Lean Body Weight
时间窗: Change from baseline at 8 weeks
Calculated in kilograms (kg) by subtracting body fat from body weight.
Cardio-respiratory Fitness Evaluation
时间窗: 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.
Balance Evaluation
时间窗: 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
时间窗: 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 Fat Percentage
时间窗: Change from baseline at 8 weeks
Body fat percentage is calculated as percentage (%) with Tanita BC730 brand scale
Body Weight
时间窗: Change from baseline at 8 weeks
Calculated in kilograms (kg) with a Tanita BC730 brand scale
Sit and Reach Test (Flexibility ) Evaluation
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Neuropathic Pain Scale(Change from baseline at 8 weeks)
- Diaposan (Vibration) Evaluation(a day before the start of treatment)
- Cognitive Status(a day before the start of treatment)
- Monofilament Evaluation(a day before the start of treatment)
- Individual Exercise İntensity(a day before the start of treatment)
研究者
Ali CEYLAN
Lecturer
Karamanoğlu Mehmetbey University