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Completed

NCT Number: NCT06061237

Effects of Aerobic Thai Dance 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.

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Key information

Conditions

Exercise Addiction Behavior Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chulalongkorn university

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Thai dance exercise

Other

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)

Primary outcomes

  1. Gait Speed

    Time frame: Baseline and 12 weeks

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

  2. Step length

    Time frame: Baseline and 12 weeks

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

  3. Single Support

    Time frame: Baseline and 12 weeks

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

  4. Double Support

    Time frame: Baseline and 12 weeks

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

  5. Cadence

    Time frame: Baseline and 12 weeks

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

  6. Postural Stability Testing

    Time frame: Baseline and 12 weeks

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

  7. 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.

  8. Limits of Stability (LOS)

    Time frame: Baseline and 12 weeks

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

  9. 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.

  10. Functional reach test

    Time frame: Baseline and 12 weeks

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

Secondary outcomes

  1. Sudomotor function

    Time frame: Baseline and 12 weeks

    Sudomotor function testing feet and hands will be measured by Sudoscan in microsiemens (µS).

  2. Leg muscle strength

    Time frame: Baseline and 12 weeks

    Leg muscle strength testing will be measured by Isokinetic dynamometer in newton meter (Nm).

  3. Ankle muscle strength

    Time frame: Baseline and 12 weeks

    Ankle Muscle strength testing will be measured by Hand-held dynamometry in kilogram (Kg).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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.

  11. 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).

  12. 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).

  13. Blood pressure

    Time frame: Baseline and 12 weeks

    Blood pressure will be measured by Sphygmomanometer in mmHg.

  14. Resting heart rate

    Time frame: Baseline and 12 weeks

    Resting heart rate will be measured by Sphygmomanometer in Times per minute (Times/ minute).

  15. Weight

    Time frame: Baseline and 12 weeks

    Weight will be measured by Body Composition Analyzer in kilogram (kg).

  16. Height

    Time frame: Baseline and 12 weeks

    Height will be measured by Body Composition Analyzer in centimeter (cm).

  17. 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.

  18. Body fat

    Time frame: Baseline and 12 weeks

    Body fat index will be measured by Dexa Scan in percentage.

  19. Muscle mass

    Time frame: Baseline and 12 weeks

    Muscle mass index will be measured by Dexa Scan in kilogram (kg).

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 29, 2023
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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