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临床试验/NCT07705958
NCT07705958尚未招募不适用

OTAGO Exercises in Individuals Diagnosed With Diabetes Mellitus Examining Its Effectiveness

Pamukkale University0 个研究点目标入组 56 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
56
主要终点
Get Up and Go Test

研究概览

简要总结

Diabetes Mellitus (DM) is a chronic metabolic disease characterized by hyperglycemia, which occurs in insulin deficiency or when the body cannot effectively use the insulin produced. Moreover, according to the "Global Report on Diabetes" data published by the World Health Organization (WHO) in 2016, it is an important public health problem, one of the four priority non-communicable diseases (1, 2). In addition to the high mortality rates caused by complications due to DM, it is also known that it can cause low quality of life and many other additional problems in individuals. Possible complications are chronic and serious problems such as heart attack, risk of stroke, kidney failure, vision loss and nerve damage. One of the most common and most disabling complications is neuropathy. It should also be noted that approximately half of diabetic neuropathy is asymptomatic and patients diagnosed with DM may have neuropathy due to causes other than diabetes (2). These complications and damage that DM can cause can lead to decreased blood flow combined with neuropathy; As a result, foot ulcers and infections may occur; Amputation rates may increase. In addition to such additional complications that diabetic neuropathy may cause, due to all these; Loss of protective plantar sensation may also occur (3). This loss of protective sensation may lead to cutaneous deficits in the lower extremities, loss of muscle strength and reflexes, and gait and balance disorders (4). The mechanism that makes an important contribution to functional joint stability and the continuity of this stability, along with the feedback mechanisms required to ensure neuromuscular control, is proprioception, which includes joint movement (kinesthesia) and joint position sense (EPH) and is a subunit of the somatosensory system (5-7). . Rehabilitation with various injuries and other clinical conditions; Clinical studies to determine its effects on joint proprioception, neuromuscular control and balance have mostly focused on knee and ankle joints (5). The main reason for this can be attributed to the great importance of the knee and ankle joints in the lower extremities in maintaining general body kinematics and balance (8). Additionally, it has been reported in the literature that EPH and plantar sensory loss are observed in individuals diagnosed with DM, and these complications may cause additional problems (10, 12, 18-22). Additionally, many studies in the literature on this subject have been conducted in individuals with diabetic neuropathy, and changes in functional parameters such as plantar sensation, proprioception, muscle strength and balance have been examined (10, 19, 20, 22, 23). However, it has been found that not only individuals with neuropathy but also individuals diagnosed with DM without neuropathy have balance disorders (24).

There are many studies in the literature about the effects of different exercise training on proprioception. In general, studies have reported that exercise training without weight bearing on the extremity has no effect on proprioception, but as a result of exercises performed with weight bearing on the extremity, a significant improvement was noted in both proprioceptive performance and muscle strength (25). In one of the most recent studies on this subject, it was stated that proprioceptive sensitivity increased in individuals with knee osteoarthritis with 8-week squat strengthening training performed by transferring weight to the extremity (26). Additionally, there are studies in the literature reporting different results regarding the effects of stretching exercises on proprioceptive performance. Some studies have reported that static stretching has no effect on proprioception, while others have reported that it has a positive effect on proprioception (27,28).

The Otago Exercise Program is an evidence-based, home-based, individually tailored strength and balance retraining program. Research shows that the Otago Exercise Program is effective in reducing the risk of death and the incidence of falls in older adults over a one-year period. In one study, falls were reduced by 35% in older adults has been reported(29)

This study was planned to examine the effectiveness of balance exercises given as a home program to individuals diagnosed with Type 2 DM.

详细描述

Participants: Patients aged 19 and over diagnosed with Type 2 Diabetes Mellitus will be included in the study.

Reviews:

After obtaining consent from the patients, their demographic data will be recorded. In addition to routine laboratory examinations (…), the balance of the patients will be evaluated with the following tests.

Get Up and Go Test: The test is performed at a distance of 3 meters. Individuals will be asked to get up from a sitting position on a chair, walk a distance of 3 meters, come back and sit down again, and the elapsed time will be recorded (30).

30 seconds Sit and Stand Test: The chair was placed in a way to ensure the safety of the subject, and the subject was asked to sit with his feet in contact with the ground and to cross his arms over his chest. The test begins when the subject is in this position and the number of complete take-offs during 30 seconds will be noted. The resulting number will be recorded as the score of the case (31).

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cases diagnosed with Diabetes Mellitus,
  • Cases that do not have any orthopedic/neurological/cardiopulmonary disease other than Diabetes Mellitus that will directly affect the evaluation results,
  • Having agreed to participate in the study voluntarily,
  • Having been diagnosed with Type 2 DM for at least 1 year

排除标准

  • Not agreeing to participate in the study,
  • Individuals with additional diseases other than DM that will affect the evaluations,
  • Having a smoking habit or history
  • Restriction in joint movements or any orthopedic/neurological/cardiopulmonary disease that may cause this,
  • Not being able to cooperate,
  • Having vision loss,
  • Having hearing loss,
  • Having a diabetic ulcer on the foot,

结局指标

主要结局

Get Up and Go Test

时间窗: Baseline and Week 4

The Timed Up and Go (TUG) test assesses functional mobility and dynamic balance. The time required to stand up from a chair, walk 3 meters, turn around, walk back, and sit down will be recorded in seconds. Lower values indicate better functional mobility.

30 seconds Sit and Stand Test:

时间窗: Baseline and 4 weeks after intervention

The 30-Second Sit-to-Stand Test assesses lower extremity muscle strength and functional performance by recording the number of complete sit-to-stand repetitions performed from a standard chair within 30 seconds. Higher scores indicate better lower extremity functional strength.

Modified Falls Efficacy Scale [MFES])

时间窗: Baseline and 4 weeks after intervention

The Modified Falls Efficacy Scale (MFES) is a self-reported questionnaire used to assess an individual's confidence in performing daily activities without falling. Scores range from 0 to 10 for each item, with higher scores indicating greater confidence and lower fear of falling.

Audit of Diabetes Dependent Quality of Life (ADDQoL

时间窗: Baseline and 4 weeks after intervention

The Audit of Diabetes-Dependent Quality of Life (ADDQoL) is a validated diabetes-specific questionnaire used to assess the impact of diabetes on quality of life across multiple life domains. Higher negative scores indicate a greater adverse impact of diabetes on quality of life, whereas scores closer to zero or positive values indicate a lesser impact or better diabetes-related quality of life.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayşenur Yılmaz

MSc Phd

Pamukkale University

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