AzTrials
AzTrials

Exercise AddictionNCT06061237

Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy

A study testing Aerobic Thai dance exercise in people with Exercise Addiction and Diabetic Neuropathies, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 to 75 years
Conditions the study is for
Exercise Addiction, Diabetic Neuropathies
What is being tested?
Aerobic Thai dance exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteThailand
Study dates
19 Sep 2022to 1 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Chulalongkorn university

    Bangkok, 10330

Other trials in Thailand

About this study

Official title: Effects of Aerobic Thai Dance on Gait, Balance and Sudomotor Function 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

Read more
  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.

Being tested
Aerobic Thai dance exercise
Keywords
Diabetes Mellitus, Diabetic Peripheral Neuropathy, Thai Dance, Gait, Balance, Sudomotor Function, DPN, Exercise
Medical subject headings
Diabetic Neuropathies, Diabetes Mellitus, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic Thai dance exerciseOther

    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)

Study groups in NCT06061237
Study groupRoleWhat they receive
Aerobic Thai dance exercise interventionExperimentalAerobic Thai dance exercise 60 minute per times, 3 times per weeks of 12 weeks.
Receives: Other: Aerobic Thai dance exercise
ControlNo interventionGive advice on exercise.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gait Speed

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

    Measured: Baseline and 12 weeks

  2. Step length

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

    Measured: Baseline and 12 weeks

  3. Single Support

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

    Measured: Baseline and 12 weeks

  4. Double Support

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

    Measured: Baseline and 12 weeks

  5. Cadence

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

    Measured: Baseline and 12 weeks

  6. Postural Stability Testing

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

    Measured: Baseline and 12 weeks

  7. 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.

    Measured: Baseline and 12 weeks

  8. Limits of Stability (LOS)

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

    Measured: Baseline and 12 weeks

  9. Time up and go test

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

    Measured: Baseline and 12 weeks

  10. Functional reach test

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

    Measured: Baseline and 12 weeks

Secondary outcomes (19)
  1. Sudomotor function

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

    Measured: Baseline and 12 weeks

  2. Leg muscle strength

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

    Measured: Baseline and 12 weeks

  3. Ankle muscle strength

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

    Measured: Baseline and 12 weeks

  4. 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.

    Measured: Baseline and 12 weeks

  5. 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.

    Measured: Baseline and 12 weeks

  6. 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.

    Measured: Baseline and 12 weeks

  7. 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.

    Measured: Baseline and 12 weeks

  8. 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.

    Measured: Baseline and 12 weeks

  9. 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).

    Measured: Baseline and 12 weeks

  10. Hemoglobin A1c (HbA1C)

    Hemoglobin A1c (HbA1C) will be measured by medical technician in faculty of Allied Health Sciences Chulalongkorn University in percentage.

    Measured: Baseline and 12 weeks

  11. 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).

    Measured: Baseline and 12 weeks

  12. 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).

    Measured: Baseline and 12 weeks

  13. Blood pressure

    Blood pressure will be measured by Sphygmomanometer in mmHg.

    Measured: Baseline and 12 weeks

  14. Resting heart rate

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

    Measured: Baseline and 12 weeks

  15. Weight

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

    Measured: Baseline and 12 weeks

  16. Height

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

    Measured: Baseline and 12 weeks

  17. Body mass index (BMI)

    Weight and height will be combined to report Body mass index (BMI) in kg/m^2.

    Measured: Baseline and 12 weeks

  18. Body fat

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

    Measured: Baseline and 12 weeks

  19. Muscle mass

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

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2023
  2. Study start19 Sep 2022
  3. Primary completion20 Oct 2022
  4. Study completion1 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06061237
Sponsor's protocol ID
0151/65
Status last verified
Oct 2023
First submitted
27 Aug 2023
Last updated
3 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Adler AI, Boyko EJ, Ahroni JH, Smith DG. Lower-extremity amputation in diabetes. The independent effects of peripheral vascular disease, sensory neuropathy, and foot ulcers. Diabetes Care. 1999 Jul;22(7):1029-35. doi: 10.2337/diacare.22.7.1029.

    PubMed 10388962
  • Ahn S, Song R. Effects of Tai Chi Exercise on glucose control, neuropathy scores, balance, and quality of life in patients with type 2 diabetes and neuropathy. J Altern Complement Med. 2012 Dec;18(12):1172-8. doi: 10.1089/acm.2011.0690. Epub 2012 Sep 17.

    PubMed 22985218
  • Akbari M, Jafari H, Moshashaee A, Forugh B. Do diabetic neuropathy patients benefit from balance training? J Rehabil Res Dev. 2012;49(2):333-8. doi: 10.1682/jrrd.2010.10.0197.

    PubMed 22773533
  • Alam U, Riley DR, Jugdey RS, Azmi S, Rajbhandari S, D'Aout K, Malik RA. Diabetic Neuropathy and Gait: A Review. Diabetes Ther. 2017 Dec;8(6):1253-1264. doi: 10.1007/s13300-017-0295-y. Epub 2017 Sep 1.

    PubMed 28864841
  • Albright A, Franz M, Hornsby G, Kriska A, Marrero D, Ullrich I, Verity LS. American College of Sports Medicine position stand. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2000 Jul;32(7):1345-60. doi: 10.1097/00005768-200007000-00024.

    PubMed 10912903
  • Baker LB. Physiology of sweat gland function: The roles of sweating and sweat composition in human health. Temperature (Austin). 2019 Jul 17;6(3):211-259. doi: 10.1080/23328940.2019.1632145. eCollection 2019.

    PubMed 31608304
  • Billot M, Handrigan GA, Simoneau M, Corbeil P, Teasdale N. Short term alteration of balance control after a reduction of plantar mechanoreceptor sensation through cooling. Neurosci Lett. 2013 Feb 22;535:40-4. doi: 10.1016/j.neulet.2012.11.022. Epub 2013 Jan 7.

    PubMed 23305721
  • Booya F, Bandarian F, Larijani B, Pajouhi M, Nooraei M, Lotfi J. Potential risk factors for diabetic neuropathy: a case control study. BMC Neurol. 2005 Dec 10;5:24. doi: 10.1186/1471-2377-5-24.

    PubMed 16336693
  • Borkosky SL, Roukis TS. Incidence of re-amputation following partial first ray amputation associated with diabetes mellitus and peripheral sensory neuropathy: a systematic review. Diabet Foot Ankle. 2012;3. doi: 10.3402/dfa.v3i0.12169. Epub 2012 Jan 20.

    PubMed 22396832
  • Casellini CM, Parson HK, Richardson MS, Nevoret ML, Vinik AI. Sudoscan, a noninvasive tool for detecting diabetic small fiber neuropathy and autonomic dysfunction. Diabetes Technol Ther. 2013 Nov;15(11):948-53. doi: 10.1089/dia.2013.0129. Epub 2013 Jul 27.

    PubMed 23889506
  • Chatterton BD, Muller S, Thomas MJ, Menz HB, Rome K, Roddy E. Inter and intra-rater repeatability of the scoring of foot pain drawings. J Foot Ankle Res. 2013 Nov 1;6(1):44. doi: 10.1186/1757-1146-6-44.

    PubMed 24180324
  • Chen L, Magliano DJ, Zimmet PZ. The worldwide epidemiology of type 2 diabetes mellitus--present and future perspectives. Nat Rev Endocrinol. 2011 Nov 8;8(4):228-36. doi: 10.1038/nrendo.2011.183.

    PubMed 22064493
  • Chyun DA, Melkus GD, Katten DM, Price WJ, Davey JA, Grey N, Heller G, Wackers FJ. The association of psychological factors, physical activity, neuropathy, and quality of life in type 2 diabetes. Biol Res Nurs. 2006 Apr;7(4):279-88. doi: 10.1177/1099800405285748.

    PubMed 16581898
  • Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, Horton ES, Castorino K, Tate DF. Physical Activity/Exercise and Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Nov;39(11):2065-2079. doi: 10.2337/dc16-1728. No abstract available.

    PubMed 27926890
  • Cox AA, Sagot Y, Hedou G, Grek C, Wilkes T, Vinik AI, Ghatnekar G. Low-Dose Pulsatile Interleukin-6 As a Treatment Option for Diabetic Peripheral Neuropathy. Front Endocrinol (Lausanne). 2017 May 2;8:89. doi: 10.3389/fendo.2017.00089. eCollection 2017.

    PubMed 28512447

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Thai dance exercise in people with Exercise Addiction and Diabetic Neuropathies, run by Chulalongkorn University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait Speed (time frame: Baseline and 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06061237, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in