Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy

NCT06061237 | Completed DMC

• 1 other identifier: 0151/65
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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. 1.The control group was advised to exercise at home for a period of 12 weeks.
2. 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.

Conditions

Exercise Addiction; Diabetic Neuropathies

Keywords

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

Outcome Measures

Primary Outcomes (10)

• Gait Speed

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

  Baseline and 12 weeks

• Step length

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

  Baseline and 12 weeks

• Single Support

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

  Baseline and 12 weeks

• Double Support

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

  Baseline and 12 weeks

• Cadence

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

  Baseline and 12 weeks

• Postural Stability Testing

  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)

  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)

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

  Baseline and 12 weeks

• Time up and go test

  Functional balance test will be measured by Time up and go test in seconds.

  Baseline and 12 weeks

• Functional reach test

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

  Baseline and 12 weeks

Secondary Outcomes (19)

• Sudomotor function

  Baseline and 12 weeks

• Leg muscle strength

  Baseline and 12 weeks

• Ankle muscle strength

  Baseline and 12 weeks

• Michigan Neuropathy Screening Instrument (MNSI)

  Baseline and 12 weeks

• Short-form McGill Pain Questionnaire (SF-MPQ)

  Baseline and 12 weeks

Study Arms (2)

Aerobic Thai dance exercise intervention

EXPERIMENTAL

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

Other: Aerobic Thai dance exercise

Control

NO INTERVENTION

Give advice on exercise.

Interventions

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)

Aerobic Thai dance exercise intervention

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn university

Bangkok, 10330, Thailand

Location

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MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 29, 2023
• Study Start: September 19, 2022
• Primary Completion: October 20, 2022
• Study Completion: August 1, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Locations

TH (1)