Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy

Sponsor

Chulalongkorn University (Other)

Overall Status

Completed

CT.gov ID

NCT06061237

Collaborator

(none)

Enrollment

Location

Arms

10.4

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Exercise Addiction Diabetic Neuropathies	Other: Aerobic Thai dance exercise	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 19, 2022

Actual Primary Completion Date :

Oct 20, 2022

Actual Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aerobic Thai dance exercise intervention Aerobic Thai dance exercise 60 minute per times, 3 times per weeks of 12 weeks.	Other: Aerobic Thai dance exercise 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)
No Intervention: Control Give advice on exercise.

Arm

Intervention/Treatment

Experimental: Aerobic Thai dance exercise intervention

Aerobic Thai dance exercise 60 minute per times, 3 times per weeks of 12 weeks.

Other: Aerobic Thai dance exercise

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)

No Intervention: Control

Give advice on exercise.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Sudomotor function [Baseline and 12 weeks]
Sudomotor function testing feet and hands will be measured by Sudoscan in microsiemens (µS).
Leg muscle strength [Baseline and 12 weeks]
Leg muscle strength testing will be measured by Isokinetic dynamometer in newton meter (Nm).
Ankle muscle strength [Baseline and 12 weeks]
Ankle Muscle strength testing will be measured by Hand-held dynamometry in kilogram (Kg).
Michigan Neuropathy Screening Instrument (MNSI) [Baseline and 12 weeks]
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.
Short-form McGill Pain Questionnaire (SF-MPQ) [Baseline and 12 weeks]
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.
Neurological symptom score (NSS) [Baseline and 12 weeks]
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.
Foot Pain Manikin [Baseline and 12 weeks]
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.
Falls Efficacy Scale International (FES-I) [Baseline and 12 weeks]
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.
Fasting Plasma Glucose (FPG) [Baseline and 12 weeks]
Fasting Plasma Glucose (FPG) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in milligrams per deciliter (mg/dL).
Hemoglobin A1c (HbA1C) [Baseline and 12 weeks]
Hemoglobin A1c (HbA1C) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in percentage.
High Density Lipoprotein (HDL) [Baseline and 12 weeks]
High Density Lipoprotein (HDL) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in milligrams per deciliter (mg/dL).
Low Density Lipoprotein (LDL) [Baseline and 12 weeks]
Low Density Lipoprotein (LDL) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in milligrams per deciliter (mg/dL).
Blood pressure [Baseline and 12 weeks]
Blood pressure will be measured by Sphygmomanometer in mmHg.
Resting heart rate [Baseline and 12 weeks]
Resting heart rate will be measured by Sphygmomanometer in Times per minute (Times/ minute).
Weight [Baseline and 12 weeks]
Weight will be measured by Body Composition Analyzer in kilogram (kg).
Height [Baseline and 12 weeks]
Height will be measured by Body Composition Analyzer in centimeter (cm).
Body mass index (BMI) [Baseline and 12 weeks]
Weight and height will be combined to report Body mass index (BMI) in kg/m^2.
Body fat [Baseline and 12 weeks]
Body fat index will be measured by Dexa Scan in percentage.
Muscle mass [Baseline and 12 weeks]
Muscle mass index will be measured by Dexa Scan in kilogram (kg).

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.