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临床试验/NCT03363386
NCT03363386已完成不适用

Effects oF Resistive Exercise or Proprioceptive Exercise Training on Balance and Superficial Sense of Patients With Type 2 Diabetes Mellitus

Yeditepe University0 个研究点目标入组 33 人开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
33
主要终点
Dynamic balance assessment

研究概览

简要总结

The aim of the study is to investigate proprioceptive exercises training combined with aerobic exercises and resistive exercises training combined with aerobic exercises on dynamic balance and superficial sense. The patients were randomly divided into Proprioceptive Exercise Training Group (PG) (n=15) and Resistive Exercise Training Group (RG) (n=15). All subjects were included exercise education program and both groups had trained aerobic exercise program for walking on treadmill (2times/wk. 6 week duration).

详细描述

The aim of the study is to investigate proprioceptive exercises training combined with aerobic exercises and resistive exercises training combined with aerobic exercises on dynamic balance and superficial sense. The study included 30 volunteers with Type 2 Diabetes Mellitus(T2DM) who were referred to Fitness Center Arif Nihat Asya Kültür Merkezi Istanbul, Turkey by a medical doctor between December 2016- March 2017 and got diagnosed and followed up at least 6 month before. Glycemic control of all the participants were assessed according to fasting blood glucose and glycolated hemoglobin (HbA1c). Waist and hip circumference was recorded in centimeters. Six minute walking test (6MWT) was used to determine functional capacity of participants. We evaluated the dynamic balance of patients by Prokin PK200, Italy. Five parameters were obtained from Prokin as; Perimeter Length (PL), Area gap percentade (AGP) Medium Speed (MS), Anteroposterior equilibrium (AP) and Mediolateral equilibrium (ML). Proprioception assessment was done with angle reproduction test in direction of dorsiflexion and plantar flexion and deviations were recorded. Superficial sense was assessed with two point discrimination test and vibration threshold was evaluated by biothesiometer. Lower extremity muscles strength were assessed with handheld dynamometer (PowerTrack II commander, JTech Medical, Midvale, UT). The patients were randomly divided into Proprioceptive Exercise Training Group (PG) and Resistive Exercise Training Group (RG). All subjects were included exercise education program and both groups had trained aerobic exercise program for walking on treadmill (2times/wk. 6 week duration). The proprioceptive exercise program was applied in PG and the resistive exercise program was applied in RG twice a week and for duration 6 week.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participating to the study in a voluntary basis
  • Patients with 30-60 years old
  • Getting diagnosed with Type 2 Diabetes Mellitus (DM) at least 6 months.

排除标准

  • Unstable cardiac condition
  • Uncontrolled Diabetes Mellitus
  • Uncontrolled Hypertension
  • Symptomatic Heart Failure, unstable angina
  • Peripheral Arterial Occlusive Disease
  • Diabetic foot ulcers
  • Part/total foot amputation
  • Myocardial infarction within 3 months prior to study
  • Coronary Artery Bypass within 3 months prior to study
  • Cerebrovascular ischemia/stroke (including TIA) within 3 months of study
  • Severe retinopathy, nephropathy
  • Thyroid Dysfunctions (hyperthyroidism, hypothyroidism).

研究组 & 干预措施

Proprioceptive Exercise Group (PG)

Experimental

Aerobic Exercise Proprioceptive Exercises

干预措施: Proprioceptive Exercises (Procedure)

Proprioceptive Exercise Group (PG)

Experimental

Aerobic Exercise Proprioceptive Exercises

干预措施: Aerobic Exercise (Procedure)

Resistive Exercise Group (RG)

Active Comparator

Aerobic Exercise Resistive Exercises

干预措施: Resistive Exercises (Procedure)

Resistive Exercise Group (RG)

Active Comparator

Aerobic Exercise Resistive Exercises

干预措施: Aerobic Exercise (Procedure)

结局指标

主要结局

Dynamic balance assessment

时间窗: 6 weeks

Prokin PK 200 was used for dynamic balance assessment

Change in fasting blood glucose level

时间窗: 6 weeks

It was evaluated for metabolic control with patient's routine controls in their clinics follow-up. At the end of the study, this metabolic variable was evaluated again in order to observe changes

Six minute walking test

时间窗: 6 weeks

Functional capacity of the patients was evaluated through 6 minute walking test

Change in HbA1c level

时间窗: 6 weeks

It was evaluated for metabolic control with patient's routine controls in their clinics follow-up. At the end of the study, this metabolic variable was evaluated again in order to observe changes

Waist and Hip Circumferences

时间窗: 6 weeks

It represents risks for cardiovascular diseases.

Lower Extremity Muscle Strength

时间窗: 6 weeks

Commander myometer was used for muscle strength assessment

Proprioception Assesment

时间窗: 6 weeks

Angle reproduction test was used

Two Point Discrimination Test

时间窗: 6 weeks

aesthesiometer was used to determine two point discrimination sensation

Vibration Perception Threshold Assessment

时间窗: 6 weeks

Biothesiometer was used for determining vibration perception threshold

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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