Clinical trial NCT06061237: 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
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Addiction
Diabetic Neuropathies
Keywords: Diabetes Mellitus
Diabetic Peripheral Neuropathy
Thai Dance
Gait
Balance
Sudomotor Function
DPN
Exercise
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 44
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Gait Speed
timeFrame: Baseline and 12 weeks
measure: Step length
timeFrame: Baseline and 12 weeks
measure: Single Support
timeFrame: Baseline and 12 weeks
measure: Double Support
timeFrame: Baseline and 12 weeks
measure: Cadence
timeFrame: Baseline and 12 weeks
measure: Postural Stability Testing
timeFrame: Baseline and 12 weeks
measure: Modified Clinical Test of Sensory Interaction in Balance (M-CTSIB)
timeFrame: Baseline and 12 weeks
measure: Limits of Stability (LOS)
timeFrame: Baseline and 12 weeks
measure: Time up and go test
timeFrame: Baseline and 12 weeks
measure: Functional reach test
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Sudomotor function
timeFrame: Baseline and 12 weeks
measure: Leg muscle strength
timeFrame: Baseline and 12 weeks
measure: Ankle muscle strength
timeFrame: Baseline and 12 weeks
measure: Michigan Neuropathy Screening Instrument (MNSI)
timeFrame: Baseline and 12 weeks
measure: Short-form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Baseline and 12 weeks
measure: Neurological symptom score (NSS)
timeFrame: Baseline and 12 weeks
measure: Foot Pain Manikin
timeFrame: Baseline and 12 weeks
measure: Falls Efficacy Scale International (FES-I)
timeFrame: Baseline and 12 weeks
measure: Fasting Plasma Glucose (FPG)
timeFrame: Baseline and 12 weeks
measure: Hemoglobin A1c (HbA1C)
timeFrame: Baseline and 12 weeks
measure: High Density Lipoprotein (HDL)
timeFrame: Baseline and 12 weeks
measure: Low Density Lipoprotein (LDL)
timeFrame: Baseline and 12 weeks
measure: Blood pressure
timeFrame: Baseline and 12 weeks
measure: Resting heart rate
timeFrame: Baseline and 12 weeks
measure: Weight
timeFrame: Baseline and 12 weeks
measure: Height
timeFrame: Baseline and 12 weeks
measure: Body mass index (BMI)
timeFrame: Baseline and 12 weeks
measure: Body fat
timeFrame: Baseline and 12 weeks
measure: Muscle mass
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn university
Study officials:
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