Improvement Through Movement - Balance Control and Somatosensory Function in People With Diabetes Mellitus Type 2: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Static balance control
研究概览
简要总结
This study focuses on improving balance control and somatosensory functions in individuals aged 60 years and older with diabetes mellitus tyoe 2 (DMT2). Older adults with DMT2 are at an increased risk of balance problems due to diabetic complications such as neuropathy, retinopathy, and possibly reduced vestibular function. The aim of the study is to investigate whether a 12-week exercise program, with or without additional balance exercises, can improve balance control, enhance somatosensory functions (such as touch and vibration thresholds), and positively impact diabetes-related parameters, including HbA1c levels.
The study is designed as a randomized controlled trial (RCT). Participants are selected based on reduced balance control identified in a prior cross-sectional study. The intervention group follows an exercise program in accordance with international guidelines, supplemented with balance exercises supervised by the researcher (physiotherapist). The control group follows the same guidelines but without balance exercises; instead, they perform relaxation exercises. Balance control is assessed both statically and dynamically, while somatosensory functions are measured, and diabetes-related parameters are collected.
The intervention is primarily home-based, supported by an activity tracker, but the balance or relaxation exercises are conducted under supervision at a designated location. This study aims to contribute to the quality of life of older adults with DMT2 by reducing balance problems and fall risks.
详细描述
Diabetes mellitus type 2 (DMT2) is the most common form of diabetes, typically occurring after the age of 40. Insulin resistance, reduced insulin secretion, or a combination of both underlie the disease, resulting in elevated blood sugar levels (hyperglycemia). The development of DMT2 is attributed to a lifestyle characterized by reduced physical activity, sedentary behavior, and poor dietary habits, leading to an increased body fat percentage, particularly through the accumulation of visceral adipose tissue. Prolonged fatty acid concentrations and hormonal imbalances result in oxidative stress, which disrupts the environment responsible for the body's sensitivity to insulin. Consequently, insulin resistance develops, and over time, reduced insulin secretion occurs due to the exhaustion of pancreatic β-cells. Risk factors for DMT2 include being overweight, obesity, metabolic disturbances (dyslipidemia, high blood pressure, hyperglycemia), and smoking. It is estimated that 8% of the Belgian population is affected by DMT2, a percentage expected to increase in the future (1). Individuals with DMT2 may develop diabetic complications if blood sugar levels (especially hyperglycemia) remain uncontrolled. At the time of diagnosis, 30% of patients already experience complications (2). After more than 10 years of diagnosis, the risk of damage to large and/or small blood vessels (angiopathy) increases. Common complications include damage to small vessels in the eyes (retinopathy) and diabetic neuropathy, which can impair tactile sensation (perception of touch/pressure) and vibratory sense (perception of vibrations) (3-5).
Physical activity has long been recognized as a key intervention for improving various diabetes-related characteristics in individuals with DMT2, such as insulin sensitivity and glucose control. Studies have shown that both aerobic (endurance) training and strength training contribute to better blood sugar regulation and overall health. These forms of physical activity not only improve muscle mass but also enhance cardiovascular health and endurance, benefiting the overall physical fitness of individuals with DMT2.
Although these general exercise interventions are effective, it remains unclear whether they are sufficient to address specific balance issues in this population. As balance control depends on a complex integration of somatosensory input, muscle strength, and coordination, the question arises whether adding targeted balance exercises to an exercise program is necessary to improve balance control.
This study investigates whether a standard exercise program consisting of aerobic training and strength training, in line with international guidelines, is sufficient to improve balance control in older adults with DMT2, or whether specific balance exercises are necessary. The distinction between the intervention and control groups allows for the evaluation of the relative impact of balance exercises. These findings could contribute to a more targeted and efficient approach to addressing balance problems in this population.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus
- •Age 60 years or older
- •Both men and women
- •Impaired balance control identified during the testing procedure for balance control, defined as a score of less than 30 seconds on the Standing on Foam with Eyes Closed test and/or less than 10 seconds on the Single Leg Stance with Eyes Open test
- •Able to understand the Dutch language.
排除标准
- •A history of central neurological disease including stroke, multiple sclerosis, Parkinson's disease, dementia or intracranial tumor
- •Severe visual impairment such as blindness, cataract or glaucoma
- •Physical impairment which would preclude subjects from participating in an exercise /physical activity program (e.g. orthopedic conditions, severe cardiac conditions, uncontrolled hypertension etc.)
- •Need of physical or material support
- •HbA1c < 7.5% (- the aim is to include patients with an HbA1c of <7.5%, but if the treating endocrinologist considers an HbA1c value of 7.5 - 8% desirable for medical reasons, this patient will still be included)
- •Use of medication that can affect balance (e.g. sedatives, antidepressants, or antipsychotics)
- •Not understanding the Dutch language
研究组 & 干预措施
Balance training arm
The intervention arm runs for 12 weeks and follows ADA/EASD guidance. Participants complete ≥150 minutes per week of aerobic activity on at least three days, choosing their preferred modality and setting (e.g., walking, treadmill, cycling, swimming, rowing, elliptical, arm ergometer; home, outdoors, gym, or group). Sedentary time should be minimized, and strength training is advised twice weekly with progressive loading. The distinctive component is balance training: 9 supervised sessions of 30 minutes delivered by a research physiotherapist or via home visit if travel is not feasible. Each session includes a warm-up, targeted static and dynamic balance work performed with and without simple equipment such as a foam pillow, and a cooldown with upper- and lower-body stretching. Exercises are progressed and individualized to challenge stability while maintaining safety and feasibility for older adults, with consistent therapis
干预措施: Balance control and exercise training (Behavioral)
Control arm
Similar to the intervention group, participants in this group will follow recommended physical activity guidelines. Participants can also choose the preferred aerobic and strength physical activity, but excluding yoga, Thai chi or other balance involving exercises. Moreover, this group will not receive any balance exercises as part of their exercise program. To have an equal one-on-one time with the researcher physical therapist, participants will receive relaxation exercises for 30 minutes per week for a total of 9 sessions.
干预措施: Relaxation and exercise training (Behavioral)
结局指标
主要结局
Static balance control
时间窗: At baseline and after 12 weeks intervention
Standing balance is measured with four modified Romberg conditions of increasing difficulty, each performed with eyes open and eyes closed. Each position is held as long as possible up to 30 seconds. Timing starts once a steady stance is achieved and stops at loss of position or at 30 seconds. Three trials are permitted per condition and the best trial counts. Scores from all eight conditions are summed to a total score ranging from 0 to 240 seconds.
Timed Up and Go
时间窗: At baseline and after 12 weeks intervention
Dynamic balance is assessed with the Timed Up and Go test using a standardized protocol, in which participants rise from a chair, walk three metres, turn, return and sit down. The time needed to complete the test is recorded in seconds. The test is performed in three trials and the best performance is retained.
Tandem Gait
时间窗: At baseline and after 12 weeks intervention
Dynamic balance is assessed with a tandem gait test in which participants attempt 20 consecutive heel to toe steps along a straight tape line. The test ends at 20 steps or at violation of the test guidelines. The score is the number of correctly performed steps, ranging from 0 to 20, and is obtained in three trials with the best performance retained.
Mini Balance Evaluation Systems Test
时间窗: At baseline and after 12 weeks intervention
Balance control is assessed with the Mini Balance Evaluation Systems Test, a 14 item performance based test covering anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. Each item is scored from 0 to 2, giving a total score ranging from 0 to 28, with higher scores indicating better balance control.
Touch pressure threshold
时间窗: At baseline and after 12 weeks intervention
Touch pressure thresholds are assessed with Semmes Weinstein monofilaments using the 4-2-1 stepping algorithm. A set of 20 logarithmically ordered filaments is applied and at each step the same filament delivers five stimuli. Testing covers six foot sites across plantar and dorsal regions and the threshold is reported per site as the filament scale value.
Vibration threshold: neurothesiometer
时间窗: At baseline and after 12 weeks intervention
Vibration thresholds are assessed with a Howell neurothesiometer. Vibration at 56 Hz is delivered while the voltage increases from 0 to 50 volts and the participant signals when vibration is first perceived. That voltage is recorded as the vibration detection threshold, with lower values indicating better vibration sense.
Vibration threshold: tuning fork
时间窗: At baseline and after 12 weeks intervention
Vibration sense is assessed with a 128 Hz Rydel Seiffer tuning fork. The fork is struck maximally and placed on standardized reference points until the vibration fades, and the participant signals when it is no longer felt. The result is read from the 0 to 8 scale of the fork, with higher scores indicating better vibration sense.
次要结局
- Self-Reported Physical activity: frequency(At week 1, week 12 of intervention and week 16 (follow-up))
- Self-reported physical activity: duration(At week 1, week 12 of intervention and week 16 (follow-up))
- Self-reported physical activity: sedentary time(At week 1, week 12 of intervention and week 16 (follow-up))
- Daily energy expenditure(At week 1, week 12 of intervention and week 16 (follow-up))
- Heart rate(At week 1, week 12 of intervention and week 16 (follow-up))
- Step count(At week 1, week 12 of intervention and week 16 (follow-up))
- Functioning confidence(At baseline and after 12 weeks of intervention)
- Anxiety(At baseline and after 12 weeks of intervention)
- Depression(At baseline and after 12 weeks of intervention)
研究者
Samera El Bakkali
Research Assistant
Universiteit Antwerpen