Comparison of the Effects of Different Exercise Programs on Lower Extremity Distal Tissue Mechanics, Muscle Strength and Neuropathy Symptoms in Type 2 Diabetics With Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Changes passive ankle stiffness compared with baseline and last measurement and Follow-up
研究概览
简要总结
To examine the effects of aerobic exercise and foot exercises in addition to aerobic exercise on lower extremity distal tissue mechanics, muscle strength and neuropathy symptoms in type 2 diabetics with peripheral neuropathy. Subjects will be divided into three groups through randomization.Subjects in the 1st group will be included in the control group and will continue their routine medical treatment for 12 weeks. Subjects in the 2nd group, in addition to their medical treatment, only aerobic exercise training,subjects in the 3rd group will be given aerobic exercise training and exercises for the foot and ankle in addition to their medical treatment. After 12 weeks of training, subjects will be followed for another 12 weeks. subjects will be evaluated before treatment, at 12 and 24 weeks.
详细描述
Diabetes Mellitus (DM) is a chronic metabolic disease that causes fat, protein and carbohydrate metabolism disorders, characterized by hyperglycemia resulting from impaired insulin secretion and insulin activity or both of these factors. The "Sixth Diabetes Atlas" published by IDF (International Diabetes Federation) in 2013 contains important data about the current situation and future of diabetes in the world.Diabetic foot ulcer is shown as the reason for 15-20% of all diabetic individuals to apply to the hospital at least once. Diabetic foot is seen as a public health factor that increases the cost, as it increases the length of stay in the hospital, long-term antibiotic therapy, and overtime of many clinics such as surgery and orthopedics.
Musculoskeletal complications of diabetes are quite common. The severity of macrovascular and microvascular complications increases over time. It poses a risk for the formation of diabetic foot ulcers in diabetic individuals. It has been reported that joint mobility decreases in individuals, especially when the first metatarsophalangeal joint extension falls below 45 degrees, the risk increases. Decrease in distal muscle strength and atrophy occur due to peripheral neuropathy and axonal loss. Loss of strength causes various deformities in the foot. In addition, it has been stated that the plantar flexors are shortened and shortening increases the forefoot pressure in individuals with diabetes. A plantar pressure of more than 70 N/cm2 in the forefoot has also been reported as a risk factor for diabetic foot ulcer.
Physiotherapy approaches for symptoms should be applied in order to eliminate the risks of the disease and increase the quality of life after complications develop and their symptoms appear. Physiotherapy approaches are applied in primary, secondary and tertiary prevention. It is the duty of physiotherapists to educate the patient in primary prevention, to apply the most appropriate exercise training to prevent the development of diabetes-related complications in secondary prevention, and to apply the most appropriate physiotherapy approaches for diabetic foot and its treatment in tertiary prevention.
An important part of diabetic foot preventive methods is preventive exercise training.
Diabetic foot protective exercise aims to minimize the risks that occur or may occur.
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 (Investigator, Outcomes Assessor)
盲法说明
The physiotherapist who evaluated the individuals participating in the study and the physiotherapist who took the treatment will not be the same. in addition, an independent statistician will do the analysis.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being diagnosed with Type 2 DM
- •Being able to walk independently
- •Getting at least 23 points from the mini mental test
- •Patients with peripheral neuropathy according to ADA criteria
排除标准
- •Presence of active ulcer
- •Amputation history
- •History of lower extremity surgery
- •Participating in a regular exercise program in the last three months
- •Having a Charcot deformity
- •Presence of major vascular complications
研究组 & 干预措施
Control Group
Subjects in this group will be asked to continue their routine medical treatment for 24 weeks.
干预措施: Routine Medical Treatment (Other)
Aerobic Exercise
In order to determine the exercise capacity of subjects, submaximal exercise test will be performed.Aerobic training will be done 3 days a week for 12 weeks. Subjects will be followed for 24 weeks.
干预措施: Routine Medical Treatment (Other)
Aerobic Exercise
In order to determine the exercise capacity of subjects, submaximal exercise test will be performed.Aerobic training will be done 3 days a week for 12 weeks. Subjects will be followed for 24 weeks.
干预措施: Aerobic Exercise (Other)
Aerobic Exercise+ Foot-Related Exercises
In addition to walking training specific to the subject in the 2nd group, special exercises will be given to the feet and ankles. These exercises will be aimed at stretching, strengthening, increasing sensory input. Treatment program will be done 3 days a week for 12 weeks. Participants will be followed for 24 weeks.
干预措施: Routine Medical Treatment (Other)
Aerobic Exercise+ Foot-Related Exercises
In addition to walking training specific to the subject in the 2nd group, special exercises will be given to the feet and ankles. These exercises will be aimed at stretching, strengthening, increasing sensory input. Treatment program will be done 3 days a week for 12 weeks. Participants will be followed for 24 weeks.
干预措施: Aerobic Exercise+ Foot-Related Exercise (Other)
结局指标
主要结局
Changes passive ankle stiffness compared with baseline and last measurement and Follow-up
时间窗: Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 20 minutes.
Passive ankle stiffness will be measured before treatment, after treatment, and at follow-up.passive ankle stiffness will be evaluated with an isokinetic dynamometer.
次要结局
- Changes foot function compared with baseline and last measurement and Follow-up(Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 5 minutes.)
- Changes (Leeds Assesment of Neuropathic Symptoms and Signs (LANSS) compared with baseline and last measurement and Follow-up(Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 10 minutes.)
- Changes vibration test compared with baseline and last measurement and Follow-up(Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 15 minutes.)
- Changes quality of life compared with baseline and last measurement and Follow-up(Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 5 minutes.)
- Changes plantar pressure compared with baseline and last measurement and Follow-up(Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 10 minutes.)
- Changes Plantar Flexion and Dorsiflexion muscle strength compared with baseline and last measurement and Follow-up(Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 20 minutes.)
- Changes Douleur Neuropathique 4 (DN4) compared with baseline and last measurement and Follow-up(Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 10 minutes.)
- Changes Michigan Neuropathy Screening Instrument (MSNI) compared with baseline and last measurement and Follow-up(Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 10 minutes.)
研究者
Cansu Koltak
Principal Investigator
Eastern Mediterranean University