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Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06061237
Enrollment
44
Registered
2023-09-29
Start date
2022-09-19
Completion date
2023-08-01
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies, Exercise Addiction

Keywords

Diabetes Mellitus, Diabetic Peripheral Neuropathy, Thai Dance, Gait, Balance, Sudomotor Function, DPN, Exercise

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 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.

Interventions

OTHERAerobic 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)

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gait SpeedBaseline and 12 weeksGait Speed will be measured by Strideway in centimeter per seconds (cm/sec).
Step lengthBaseline and 12 weeksStep length will be measured by Strideway in centimeter (cm).
Single SupportBaseline and 12 weeksSingle Support will be measured by Strideway in seconds (sec).
Double SupportBaseline and 12 weeksDouble Support will be measured by Strideway in seconds (sec).
CadenceBaseline and 12 weeksCadence will be measured by Strideway in steps per minute (steps/minute).
Postural Stability TestingBaseline and 12 weeksPostural Stability Testing will be measured by Biodex balance system in score.
Modified Clinical Test of Sensory Interaction in Balance (M-CTSIB)Baseline and 12 weeksModified 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 weeksLimits of Stability (LOS) will be measured by Biodex balance system in score.
Time up and go testBaseline and 12 weeksFunctional balance test will be measured by Time up and go test in seconds.
Functional reach testBaseline and 12 weeksFunctional balance test will be measured by Functional reach test in centimeter.

Secondary

MeasureTime frameDescription
High Density Lipoprotein (HDL)Baseline and 12 weeksHigh 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 weeksLow Density Lipoprotein (LDL) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in milligrams per deciliter (mg/dL).
Blood pressureBaseline and 12 weeksBlood pressure will be measured by Sphygmomanometer in mmHg.
Resting heart rateBaseline and 12 weeksResting heart rate will be measured by Sphygmomanometer in Times per minute (Times/ minute).
Michigan Neuropathy Screening Instrument (MNSI)Baseline and 12 weeksQuestionnaire 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.
HeightBaseline and 12 weeksHeight will be measured by Body Composition Analyzer in centimeter (cm).
Body mass index (BMI)Baseline and 12 weeksWeight and height will be combined to report Body mass index (BMI) in kg/m\^2.
Body fatBaseline and 12 weeksBody fat index will be measured by Dexa Scan in percentage.
Muscle massBaseline and 12 weeksMuscle mass index will be measured by Dexa Scan in kilogram (kg).
WeightBaseline and 12 weeksWeight will be measured by Body Composition Analyzer in kilogram (kg).
Short-form McGill Pain Questionnaire (SF-MPQ)Baseline and 12 weeksQuestionnaire 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.
Sudomotor functionBaseline and 12 weeksSudomotor function testing feet and hands will be measured by Sudoscan in microsiemens (µS).
Leg muscle strengthBaseline and 12 weeksLeg muscle strength testing will be measured by Isokinetic dynamometer in newton meter (Nm).
Ankle muscle strengthBaseline and 12 weeksAnkle Muscle strength testing will be measured by Hand-held dynamometry in kilogram (Kg).
Neurological symptom score (NSS)Baseline and 12 weeksQuestionnaire 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 ManikinBaseline and 12 weeksQuestionnaire 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 weeksQuestionnaire 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 weeksFasting 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 weeksHemoglobin A1c (HbA1C) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in percentage.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026