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临床试验/NCT06061237
NCT06061237已完成不适用

Effects of Aerobic Thai Dance on Gait, Balance and Sudomotor Function in Patient With Diabetic Peripheral Neuropathy

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Step length

研究概览

简要总结

The goal of this type of study is clinical trial. This to learn about effects of applied aerobic Thai dance exercise on gait balance and sudomotor function in patient with diabetic peripheral neuropathy. Test variables of gait, balance, function of sudomotor, Physiological data such as pulse, blood pressure, body composition, ankle and leg muscle strength, compare with control and experimental group in diabetes with peripheral neuropathy.

The main question Question 1: Dose Applied aerobic Thai dance exercise affects gait and balance in diabetic patients with peripheral neuropathy? Question 2: Does applied aerobic Thai dance exercise affect sudomotor function in diabetic patients with peripheral neuropathy? Participants will divided into 2 groups: the control group and the experimental group. By randomly sampling 22 people from each group

  1. The control group was advised to exercise at home for a period of 12 weeks.
  2. The experimental group participated in Applied aerobic Thai dance exercise 60 minutes per session, 3 times per week, for a period of 12 weeks.

After 12 weeks, variable data were collected and to compare within and between groups.

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
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with type 2 diabetes between the ages of 60 and
  • The BMI index is between 18.5 - 29.9 kg/m
  • MNSI score between 2.5 - 7.5 points.
  • There were no exercise-related complications from the PAR -Q assessment.
  • Light to moderate level of physical activity.
  • Not being a person with severe optic neuropathy (Severe-NPDR and Severe-PDR).
  • No wounds or infections on the feet.
  • No musculoskeletal abnormalities.
  • Not being a Pacemaker Implantation Person, No History of Heart Failure, Evaluated New York Heart Association Classification (NYHA) not over Functional Class II, If CAD must be treated, No history of Atrial Fibrillation severely wrong.
  • The doctor did not have a plan to adjust the medication in the last 3 months.

排除标准

  • MNSI score greater than or equal to 8 points or more.
  • Participants lacked more than 20 percent of their exercise program.
  • Participants had foot ulcers and infections during the experiment.
  • Vitamins B1, 6 and 12 were taken during the trial.
  • The subject withdrew from the experiment.

结局指标

主要结局

Step length

时间窗: Baseline and 12 weeks

Step length will be measured by Strideway in centimeter (cm).

Single Support

时间窗: Baseline and 12 weeks

Single Support will be measured by Strideway in seconds (sec).

Double Support

时间窗: Baseline and 12 weeks

Double Support will be measured by Strideway in seconds (sec).

Gait Speed

时间窗: Baseline and 12 weeks

Gait Speed will be measured by Strideway in centimeter per seconds (cm/sec).

Cadence

时间窗: Baseline and 12 weeks

Cadence will be measured by Strideway in steps per minute (steps/minute).

Postural Stability Testing

时间窗: Baseline and 12 weeks

Postural Stability Testing will be measured by Biodex balance system in score.

Limits of Stability (LOS)

时间窗: Baseline and 12 weeks

Limits of Stability (LOS) will be measured by Biodex balance system in score.

Modified Clinical Test of Sensory Interaction in Balance (M-CTSIB)

时间窗: Baseline and 12 weeks

Modified Clinical Test of Sensory Interaction in Balance (M-CTSIB) will be measured by Biodex balance system in score.

Functional reach test

时间窗: Baseline and 12 weeks

Functional balance test will be measured by Functional reach test in centimeter.

Time up and go test

时间窗: Baseline and 12 weeks

Functional balance test will be measured by Time up and go test in seconds.

次要结局

  • Sudomotor function(Baseline and 12 weeks)
  • Ankle muscle strength(Baseline and 12 weeks)
  • Foot Pain Manikin(Baseline and 12 weeks)
  • Low Density Lipoprotein (LDL)(Baseline and 12 weeks)
  • Leg muscle strength(Baseline and 12 weeks)
  • Fasting Plasma Glucose (FPG)(Baseline and 12 weeks)
  • Height(Baseline and 12 weeks)
  • Body mass index (BMI)(Baseline and 12 weeks)
  • Michigan Neuropathy Screening Instrument (MNSI)(Baseline and 12 weeks)
  • Short-form McGill Pain Questionnaire (SF-MPQ)(Baseline and 12 weeks)
  • Neurological symptom score (NSS)(Baseline and 12 weeks)
  • Falls Efficacy Scale International (FES-I)(Baseline and 12 weeks)
  • High Density Lipoprotein (HDL)(Baseline and 12 weeks)
  • Weight(Baseline and 12 weeks)
  • Body fat(Baseline and 12 weeks)
  • Hemoglobin A1c (HbA1C)(Baseline and 12 weeks)
  • Resting heart rate(Baseline and 12 weeks)
  • Blood pressure(Baseline and 12 weeks)
  • Muscle mass(Baseline and 12 weeks)

研究者

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

Thammarat Koksungnoen

Principal investigator

Chulalongkorn University

研究点 (2)

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