Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy

October 2, 2023 updated by: Thammarat Koksungnoen, Chulalongkorn University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2022

Primary Completion (Actual)

October 20, 2022

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

August 27, 2023

First Submitted That Met QC Criteria

September 24, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0151/65

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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