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Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy

Primary Purpose

Exercise Addiction, Diabetic Neuropathies

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Aerobic Thai dance exercise
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise Addiction focused on measuring Diabetes Mellitus, Diabetic Peripheral Neuropathy, Thai Dance, Gait, Balance, Sudomotor Function, DPN, Exercise

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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. 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.

Sites / Locations

  • Chulalongkorn university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aerobic Thai dance exercise intervention

Control

Arm Description

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

Give advice on exercise.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sudomotor function
Sudomotor function testing feet and hands will be measured by Sudoscan in microsiemens (µS).
Leg muscle strength
Leg muscle strength testing will be measured by Isokinetic dynamometer in newton meter (Nm).
Ankle muscle strength
Ankle Muscle strength testing will be measured by Hand-held dynamometry in kilogram (Kg).
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.
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.
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.
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.
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.
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).
Hemoglobin A1c (HbA1C)
Hemoglobin A1c (HbA1C) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in percentage.
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).
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).
Blood pressure
Blood pressure will be measured by Sphygmomanometer in mmHg.
Resting heart rate
Resting heart rate will be measured by Sphygmomanometer in Times per minute (Times/ minute).
Weight
Weight will be measured by Body Composition Analyzer in kilogram (kg).
Height
Height will be measured by Body Composition Analyzer in centimeter (cm).
Body mass index (BMI)
Weight and height will be combined to report Body mass index (BMI) in kg/m^2.
Body fat
Body fat index will be measured by Dexa Scan in percentage.
Muscle mass
Muscle mass index will be measured by Dexa Scan in kilogram (kg).

Full Information

First Posted
August 27, 2023
Last Updated
October 2, 2023
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT06061237
Brief Title
Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy
Official Title
Effects of Aerobic Thai Dance on Gait, Balance and Sudomotor Function in Patient With Diabetic Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Addiction, Diabetic Neuropathies
Keywords
Diabetes Mellitus, Diabetic Peripheral Neuropathy, Thai Dance, Gait, Balance, Sudomotor Function, DPN, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Thai dance exercise intervention
Arm Type
Experimental
Arm Description
Aerobic Thai dance exercise 60 minute per times, 3 times per weeks of 12 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Give advice on exercise.
Intervention Type
Other
Intervention Name(s)
Aerobic Thai dance exercise
Intervention Description
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 Outcome Measure Information:
Title
Gait Speed
Description
Gait Speed will be measured by Strideway in centimeter per seconds (cm/sec).
Time Frame
Baseline and 12 weeks
Title
Step length
Description
Step length will be measured by Strideway in centimeter (cm).
Time Frame
Baseline and 12 weeks
Title
Single Support
Description
Single Support will be measured by Strideway in seconds (sec).
Time Frame
Baseline and 12 weeks
Title
Double Support
Description
Double Support will be measured by Strideway in seconds (sec).
Time Frame
Baseline and 12 weeks
Title
Cadence
Description
Cadence will be measured by Strideway in steps per minute (steps/minute).
Time Frame
Baseline and 12 weeks
Title
Postural Stability Testing
Description
Postural Stability Testing will be measured by Biodex balance system in score.
Time Frame
Baseline and 12 weeks
Title
Modified Clinical Test of Sensory Interaction in Balance (M-CTSIB)
Description
Modified Clinical Test of Sensory Interaction in Balance (M-CTSIB) will be measured by Biodex balance system in score.
Time Frame
Baseline and 12 weeks
Title
Limits of Stability (LOS)
Description
Limits of Stability (LOS) will be measured by Biodex balance system in score.
Time Frame
Baseline and 12 weeks
Title
Time up and go test
Description
Functional balance test will be measured by Time up and go test in seconds.
Time Frame
Baseline and 12 weeks
Title
Functional reach test
Description
Functional balance test will be measured by Functional reach test in centimeter.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Sudomotor function
Description
Sudomotor function testing feet and hands will be measured by Sudoscan in microsiemens (µS).
Time Frame
Baseline and 12 weeks
Title
Leg muscle strength
Description
Leg muscle strength testing will be measured by Isokinetic dynamometer in newton meter (Nm).
Time Frame
Baseline and 12 weeks
Title
Ankle muscle strength
Description
Ankle Muscle strength testing will be measured by Hand-held dynamometry in kilogram (Kg).
Time Frame
Baseline and 12 weeks
Title
Michigan Neuropathy Screening Instrument (MNSI)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Short-form McGill Pain Questionnaire (SF-MPQ)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Neurological symptom score (NSS)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Foot Pain Manikin
Description
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.
Time Frame
Baseline and 12 weeks
Title
Falls Efficacy Scale International (FES-I)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Fasting Plasma Glucose (FPG)
Description
Fasting Plasma Glucose (FPG) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in milligrams per deciliter (mg/dL).
Time Frame
Baseline and 12 weeks
Title
Hemoglobin A1c (HbA1C)
Description
Hemoglobin A1c (HbA1C) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in percentage.
Time Frame
Baseline and 12 weeks
Title
High Density Lipoprotein (HDL)
Description
High Density Lipoprotein (HDL) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in milligrams per deciliter (mg/dL).
Time Frame
Baseline and 12 weeks
Title
Low Density Lipoprotein (LDL)
Description
Low Density Lipoprotein (LDL) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in milligrams per deciliter (mg/dL).
Time Frame
Baseline and 12 weeks
Title
Blood pressure
Description
Blood pressure will be measured by Sphygmomanometer in mmHg.
Time Frame
Baseline and 12 weeks
Title
Resting heart rate
Description
Resting heart rate will be measured by Sphygmomanometer in Times per minute (Times/ minute).
Time Frame
Baseline and 12 weeks
Title
Weight
Description
Weight will be measured by Body Composition Analyzer in kilogram (kg).
Time Frame
Baseline and 12 weeks
Title
Height
Description
Height will be measured by Body Composition Analyzer in centimeter (cm).
Time Frame
Baseline and 12 weeks
Title
Body mass index (BMI)
Description
Weight and height will be combined to report Body mass index (BMI) in kg/m^2.
Time Frame
Baseline and 12 weeks
Title
Body fat
Description
Body fat index will be measured by Dexa Scan in percentage.
Time Frame
Baseline and 12 weeks
Title
Muscle mass
Description
Muscle mass index will be measured by Dexa Scan in kilogram (kg).
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Chulalongkorn university
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

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Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy

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