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Clinical Trials/NCT06061237
NCT06061237CompletedNot Applicable

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

Chulalongkorn University1 site in 1 country44 target enrollmentStarted: September 19, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
1
Primary Endpoint
Step length

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
60 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosed with type 2 diabetes between the ages of 60 and
  • •The BMI index is between 18.5 - 29.9 kg/m
  • •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.

Arms & Interventions

Aerobic Thai dance exercise intervention

Experimental

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

Intervention: Aerobic Thai dance exercise (Other)

Control

No Intervention

Give advice on exercise.

Outcomes

Primary Outcomes

Step length

Time Frame: Baseline and 12 weeks

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

Single Support

Time Frame: Baseline and 12 weeks

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

Double Support

Time Frame: Baseline and 12 weeks

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

Gait Speed

Time Frame: Baseline and 12 weeks

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

Cadence

Time Frame: Baseline and 12 weeks

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

Postural Stability Testing

Time Frame: Baseline and 12 weeks

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

Limits of Stability (LOS)

Time Frame: Baseline and 12 weeks

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

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.

Functional reach test

Time Frame: Baseline and 12 weeks

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

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.

Secondary Outcomes

  • Sudomotor function(Baseline and 12 weeks)
  • Hemoglobin A1c (HbA1C)(Baseline and 12 weeks)
  • Resting heart rate(Baseline and 12 weeks)
  • Ankle muscle strength(Baseline and 12 weeks)
  • Foot Pain Manikin(Baseline and 12 weeks)
  • Low Density Lipoprotein (LDL)(Baseline and 12 weeks)
  • Leg muscle strength(Baseline and 12 weeks)
  • Fasting Plasma Glucose (FPG)(Baseline and 12 weeks)
  • Height(Baseline and 12 weeks)
  • Body mass index (BMI)(Baseline and 12 weeks)
  • Michigan Neuropathy Screening Instrument (MNSI)(Baseline and 12 weeks)
  • Short-form McGill Pain Questionnaire (SF-MPQ)(Baseline and 12 weeks)
  • Neurological symptom score (NSS)(Baseline and 12 weeks)
  • Falls Efficacy Scale International (FES-I)(Baseline and 12 weeks)
  • High Density Lipoprotein (HDL)(Baseline and 12 weeks)
  • Weight(Baseline and 12 weeks)
  • Body fat(Baseline and 12 weeks)
  • Blood pressure(Baseline and 12 weeks)
  • Muscle mass(Baseline and 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thammarat Koksungnoen

Principal investigator

Chulalongkorn University

Study Sites (1)

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