NCT Number: NCT07705958
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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).
It will be evaluated with the Modified Falls Efficacy Scale [MFES]. MFES consists of 14 questions about some specific activities performed inside and outside the home (such as dressing, bathing). The sense of safety felt in performing each activity without falling will be evaluated on a scale ranging from "0" (not at all safe) to "10" (completely safe). The total score will be calculated by dividing the arithmetic sum of the answer values for each question by the number of answered questions. The higher the score, the higher the sense of safety and competence against falling. Turkish validity and reliability were determined by Korkmaz et al. (32,33).
Audit of Diabetes Dependent Quality of Life (ADDQoL) scale: It was developed in the early 1990s to measure the impact of diabetes on quality of life. It was created to evaluate the quality of life of patients diagnosed with Type 1 and 2 DM. It has been translated into Turkish and many other languages. In the study conducted by Demirci et al. in 2012, the Cronbach's alpha value of Turkish validity and reliability was found to be 0.90-0.91. This is a third generation individualized quality of life scale that allows self-assessment in their living spaces. It measures the impact and importance of these topics on their lives. ADDQoL begins with two questions assessing quality of life and quality of life without diabetes. The evaluation of these two questions is done separately from the other questions. In the first question, +3 is scored as excellent, 0 as neither good nor bad, and -3 as extremely bad. In the second question, -3 is scored as much better, 0 as the same, and +1 as worse. Other questions start with "If I didn't have diabetes" and ask what it would be like in the relevant field. The degree of importance of each issue for the individual is also questioned. When evaluating, the impact on the person is scored as -3, that is, much more, and +1, less. Importance is scored as 0 not at all important and +3 as very important. The weighted impact score is obtained by multiplying the impact and importance score. This value varies between -9 (maximum negative impact of diabetes) and +3 (maximum positive impact of diabetes). When calculating the weighted average impact, the scores obtained from the multiplications are added up for each case and the collected subject It is divided by the number. This value varies between -9 (the most negative effect of diabetes) and +3 (the most positive effect of diabetes). Thus, it is decided that diabetes affects the person to the extent in all these areas (36).
Physiotherapy and Rehabilitation Program:
Patients will be randomly divided into two groups. Otago exercises and walking will be recommended for the balance group, and only walking will be recommended for the control group. Balance exercises are within the scope of the Otago exercise program and will be given as a home program. They will be asked to do it for 40 minutes, 5 days a week for 4 weeks. Both groups will be asked to walk for half an hour 2 days a week. Patients will be given a follow-up form and will be called weekly.
Otago exercises will be given to patients as a home program. The Otago Exercise Program starts with stretching exercises. It includes five strengthening exercises and 12 balance exercises. Participants will be asked to perform the exercises 5 days a week (10 repetitions). Additionally, participants will be asked to walk for 30 minutes twice a week (29).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Otago exercises and walking will be recommended for the balance group, and only walking will be recommended for the control group. Balance exercises are within the scope of the Otago exercise program and will be given as a home program. They will be asked to do it for 40 minutes, 5 days a week for 4 weeks. Both groups will be asked to walk for half an hour 2 days a week. Patients will be given a follow-up form and will be called weekly.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Pamukkale University
Other
OTAGO Exercises in Individuals Diagnosed With Diabetes Mellitus Examining Its Effectiveness
Acronym: OTAGO in DM
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