Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy

Study Overview
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Brief Summary
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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 The control group was advised to exercise at home for a period of 12 weeks. 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.

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

Conditions
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Exercise Addiction, Diabetic Neuropathies

Intervention / Treatment
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* Other: Aerobic Thai dance exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 2 diabetes between the ages of 60 and 75. The BMI index is between 18.5 - 29.9 kg/m2. 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic Thai dance exercise intervention<br>Aerobic Thai dance exercise 60 minute per times, 3 times per weeks of 12 weeks. | Other: Aerobic Thai dance exercise<br>* Aerobic Thai dance exercise 60 minute per times, 3 times per weeks of 12 weeks. Aerobic exercise of modulate intensity (12-13 Borg's RPE)<br>|
| No Intervention: Control<br>Give advice on exercise. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Speed | Gait Speed will be measured by Strideway in centimeter per seconds (cm/sec). | Baseline and 12 weeks | 
| Step length | Step length will be measured by Strideway in centimeter (cm). | Baseline and 12 weeks | 
| Single Support | Single Support will be measured by Strideway in seconds (sec). | Baseline and 12 weeks | 
| Double Support | Double Support will be measured by Strideway in seconds (sec). | Baseline and 12 weeks | 
| Cadence | Cadence will be measured by Strideway in steps per minute (steps/minute). | Baseline and 12 weeks | 
| Postural Stability Testing | Postural Stability Testing will be measured by Biodex balance system in score. | Baseline and 12 weeks | 
| Modified Clinical Test of Sensory Interaction in Balance (M-CTSIB) | Modified Clinical Test of Sensory Interaction in Balance (M-CTSIB) will be measured by Biodex balance system in score. | Baseline and 12 weeks | 
| Limits of Stability (LOS) | Limits of Stability (LOS) will be measured by Biodex balance system in score. | Baseline and 12 weeks | 
| Time up and go test | Functional balance test will be measured by Time up and go test in seconds. | Baseline and 12 weeks | 
| Functional reach test | Functional balance test will be measured by Functional reach test in centimeter. | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sudomotor function | Sudomotor function testing feet and hands will be measured by Sudoscan in microsiemens (µS). | Baseline and 12 weeks | 
| Leg muscle strength | Leg muscle strength testing will be measured by Isokinetic dynamometer in newton meter (Nm). | Baseline and 12 weeks | 
| Ankle muscle strength | Ankle Muscle strength testing will be measured by Hand-held dynamometry in kilogram (Kg). | Baseline and 12 weeks | 
| Michigan Neuropathy Screening Instrument (MNSI) | Questionnaire variables will be measured by Michigan Neuropathy Screening Instrument (MNSI) in score. The scale's range in score is from 0 to 13. Cut off greater than or equal to 2 scores and a low score represents mild neuropathy, whereas a high score represents severe neuropathy. | Baseline and 12 weeks | 
| Short-form McGill Pain Questionnaire (SF-MPQ) | Questionnaire variables will be measured by Short-form McGill Pain Questionnaire (SF-MPQ) in score. The scale's range in score is from 0 to 60. A low score represents no pain, whereas a high score represents worse pain. | Baseline and 12 weeks | 
| Neurological symptom score (NSS) | Questionnaire variables will be measured by Neurological symptom score (NSS) in score. The scale's range in score is from 0 to 18. A low score represents mild neuropathic symptoms, whereas a high score represents severe neuropathic symptoms. | Baseline and 12 weeks | 
| Foot Pain Manikin | Questionnaire variables will be measured by Foot Pain Manikin in score. The scale's range in score is from 0 to 50. A low score represents no area of pain, whereas a high score represents a wide area of pain. | Baseline and 12 weeks | 
| Falls Efficacy Scale International (FES-I) | Questionnaire variables will be measured by Falls Efficacy Scale International (FES-I) in score. The scale's range in score is from 16 to 64. A low score represents no concern about falling, whereas a high score represents severe concern about falling. | Baseline and 12 weeks | 
| Fasting Plasma Glucose (FPG) | Fasting Plasma Glucose (FPG) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in milligrams per deciliter (mg/dL). | Baseline and 12 weeks | 
| Hemoglobin A1c (HbA1C) | Hemoglobin A1c (HbA1C) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in percentage. | Baseline and 12 weeks | 
| High Density Lipoprotein (HDL) | High Density Lipoprotein (HDL) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in milligrams per deciliter (mg/dL). | Baseline and 12 weeks | 
| Low Density Lipoprotein (LDL) | Low Density Lipoprotein (LDL) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in milligrams per deciliter (mg/dL). | Baseline and 12 weeks | 
| Blood pressure | Blood pressure will be measured by Sphygmomanometer in mmHg. | Baseline and 12 weeks | 
| Resting heart rate | Resting heart rate will be measured by Sphygmomanometer in Times per minute (Times/ minute). | Baseline and 12 weeks | 
| Weight | Weight will be measured by Body Composition Analyzer in kilogram (kg). | Baseline and 12 weeks | 
| Height | Height will be measured by Body Composition Analyzer in centimeter (cm). | Baseline and 12 weeks | 
| Body mass index (BMI) | Weight and height will be combined to report Body mass index (BMI) in kg/m^2. | Baseline and 12 weeks | 
| Body fat | Body fat index will be measured by Dexa Scan in percentage. | Baseline and 12 weeks | 
| Muscle mass | Muscle mass index will be measured by Dexa Scan in kilogram (kg). | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Diabetic Peripheral Neuropathy, Thai Dance, Gait, Balance, Sudomotor Function, DPN, Exercise