Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy

NCT ID: NCT06061237

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-19

Study Completion Date

2023-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Exercise Addiction Diabetic Neuropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Aerobic Thai dance exercise intervention

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

Group Type EXPERIMENTAL

Aerobic Thai dance exercise

Intervention Type 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)

Control

Give advice on exercise.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerobic Thai dance exercise

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)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Thammarat Koksungnoen

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chulalongkorn university

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 10388962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22985218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22773533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28864841 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10912903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31608304 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23305721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16336693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22396832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23889506 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24180324 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22064493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16581898 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27926890 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28512447 (View on PubMed)

Dixit S, Maiya A, Shastry B. Effect of aerobic exercise on quality of life in population with diabetic peripheral neuropathy in type 2 diabetes: a single blind, randomized controlled trial. Qual Life Res. 2014 Jun;23(5):1629-40. doi: 10.1007/s11136-013-0602-7. Epub 2013 Dec 11.

Reference Type BACKGROUND
PMID: 24326731 (View on PubMed)

Fernando M, Crowther R, Lazzarini P, Sangla K, Cunningham M, Buttner P, Golledge J. Biomechanical characteristics of peripheral diabetic neuropathy: A systematic review and meta-analysis of findings from the gait cycle, muscle activity and dynamic barefoot plantar pressure. Clin Biomech (Bristol). 2013 Oct;28(8):831-45. doi: 10.1016/j.clinbiomech.2013.08.004. Epub 2013 Aug 27.

Reference Type BACKGROUND
PMID: 24035444 (View on PubMed)

Ferreira JP, Sartor CD, Leal AM, Sacco IC, Sato TO, Ribeiro IL, Soares AS, Cunha JE, Salvini TF. The effect of peripheral neuropathy on lower limb muscle strength in diabetic individuals. Clin Biomech (Bristol). 2017 Mar;43:67-73. doi: 10.1016/j.clinbiomech.2017.02.003. Epub 2017 Feb 9.

Reference Type BACKGROUND
PMID: 28213167 (View on PubMed)

Glatte P, Buchmann SJ, Hijazi MM, Illigens BM, Siepmann T. Architecture of the Cutaneous Autonomic Nervous System. Front Neurol. 2019 Sep 10;10:970. doi: 10.3389/fneur.2019.00970. eCollection 2019.

Reference Type BACKGROUND
PMID: 31551921 (View on PubMed)

Holloszy JO. Exercise-induced increase in muscle insulin sensitivity. J Appl Physiol (1985). 2005 Jul;99(1):338-43. doi: 10.1152/japplphysiol.00123.2005.

Reference Type BACKGROUND
PMID: 16036907 (View on PubMed)

Kelly C, Fleischer A, Yalla S, Grewal GS, Albright R, Berns D, Crews R, Najafi B. Fear of falling is prevalent in older adults with diabetes mellitus but is unrelated to level of neuropathy. J Am Podiatr Med Assoc. 2013 Nov-Dec;103(6):480-8. doi: 10.7547/1030480.

Reference Type BACKGROUND
PMID: 24297984 (View on PubMed)

Kukidome D, Nishikawa T, Sato M, Nishi Y, Shimamura R, Kawashima J, Shimoda S, Mizuta H, Araki E. Impaired balance is related to the progression of diabetic complications in both young and older adults. J Diabetes Complications. 2017 Aug;31(8):1275-1282. doi: 10.1016/j.jdiacomp.2017.05.014. Epub 2017 Jun 4.

Reference Type BACKGROUND
PMID: 28610947 (View on PubMed)

Leelarungrayub D, Saidee K, Pothongsunun P, Pratanaphon S, YanKai A, Bloomer RJ. Six weeks of aerobic dance exercise improves blood oxidative stress status and increases interleukin-2 in previously sedentary women. J Bodyw Mov Ther. 2011 Jul;15(3):355-62. doi: 10.1016/j.jbmt.2010.03.006. Epub 2010 Apr 28.

Reference Type BACKGROUND
PMID: 21665113 (View on PubMed)

Morrison S, Colberg SR, Parson HK, Vinik AI. Exercise improves gait, reaction time and postural stability in older adults with type 2 diabetes and neuropathy. J Diabetes Complications. 2014 Sep-Oct;28(5):715-22. doi: 10.1016/j.jdiacomp.2014.04.007. Epub 2014 Apr 18.

Reference Type BACKGROUND
PMID: 24929798 (View on PubMed)

Mueller MJ, Tuttle LJ, Lemaster JW, Strube MJ, McGill JB, Hastings MK, Sinacore DR. Weight-bearing versus nonweight-bearing exercise for persons with diabetes and peripheral neuropathy: a randomized controlled trial. Arch Phys Med Rehabil. 2013 May;94(5):829-38. doi: 10.1016/j.apmr.2012.12.015. Epub 2012 Dec 28.

Reference Type BACKGROUND
PMID: 23276801 (View on PubMed)

Muller KA, Ryals JM, Feldman EL, Wright DE. Abnormal muscle spindle innervation and large-fiber neuropathy in diabetic mice. Diabetes. 2008 Jun;57(6):1693-701. doi: 10.2337/db08-0022. Epub 2008 Mar 24.

Reference Type BACKGROUND
PMID: 18362211 (View on PubMed)

Noopud P, Suputtitada A, Khongprasert S, Kanungsukkasem V. Effects of Thai traditional dance on balance performance in daily life among older women. Aging Clin Exp Res. 2019 Jul;31(7):961-967. doi: 10.1007/s40520-018-1040-8. Epub 2018 Oct 8.

Reference Type BACKGROUND
PMID: 30298380 (View on PubMed)

Oh TJ, Kang S, Lee JE, Moon JH, Choi SH, Lim S, Jang HC. Association between deterioration in muscle strength and peripheral neuropathy in people with diabetes. J Diabetes Complications. 2019 Aug;33(8):598-601. doi: 10.1016/j.jdiacomp.2019.04.007. Epub 2019 Apr 13.

Reference Type BACKGROUND
PMID: 31129004 (View on PubMed)

Okada S, Hiuge A, Makino H, Nagumo A, Takaki H, Konishi H, Goto Y, Yoshimasa Y, Miyamoto Y. Effect of exercise intervention on endothelial function and incidence of cardiovascular disease in patients with type 2 diabetes. J Atheroscler Thromb. 2010 Aug 31;17(8):828-33. doi: 10.5551/jat.3798. Epub 2010 May 13.

Reference Type BACKGROUND
PMID: 20467191 (View on PubMed)

Hewston P, Deshpande N. Fear of Falling and Balance Confidence in Older Adults With Type 2 Diabetes Mellitus: A Scoping Review. Can J Diabetes. 2018 Dec;42(6):664-670. doi: 10.1016/j.jcjd.2018.02.009. Epub 2018 Mar 6.

Reference Type BACKGROUND
PMID: 29914779 (View on PubMed)

Pirker W, Katzenschlager R. Gait disorders in adults and the elderly : A clinical guide. Wien Klin Wochenschr. 2017 Feb;129(3-4):81-95. doi: 10.1007/s00508-016-1096-4. Epub 2016 Oct 21.

Reference Type BACKGROUND
PMID: 27770207 (View on PubMed)

Plagemann A, Heidrich I, Gotz F, Rohde W, Dorner G. Obesity and enhanced diabetes and cardiovascular risk in adult rats due to early postnatal overfeeding. Exp Clin Endocrinol. 1992;99(3):154-8. doi: 10.1055/s-0029-1211159.

Reference Type BACKGROUND
PMID: 1526266 (View on PubMed)

Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.

Reference Type BACKGROUND
PMID: 27999003 (View on PubMed)

Raymond B, Steriovski J, Gillyard K, Yang C, Wu SC, Crews RT. Choosing a Vibratory Test to Pair With Semmes Weinstein Monofilament Testing for Evaluating Lower Extremity Sensation in Patients With Diabetes: A Comparison of Three Vibratory Methodologies. J Diabetes Sci Technol. 2020 Jan;14(1):8-15. doi: 10.1177/1932296819849478. Epub 2019 May 21.

Reference Type BACKGROUND
PMID: 31113243 (View on PubMed)

Seferovic JP, Pfeffer MA, Claggett B, Desai AS, de Zeeuw D, Haffner SM, McMurray JJV, Parving HH, Solomon SD, Chaturvedi N. Three-question set from Michigan Neuropathy Screening Instrument adds independent prognostic information on cardiovascular outcomes: analysis of ALTITUDE trial. Diabetologia. 2018 Mar;61(3):581-588. doi: 10.1007/s00125-017-4485-y. Epub 2017 Nov 3.

Reference Type BACKGROUND
PMID: 29098323 (View on PubMed)

Spink MJ, Fotoohabadi MR, Menz HB. Foot and ankle strength assessment using hand-held dynamometry: reliability and age-related differences. Gerontology. 2010;56(6):525-32. doi: 10.1159/000264655. Epub 2009 Dec 3.

Reference Type BACKGROUND
PMID: 19955706 (View on PubMed)

Sun PC, Lin HD, Jao SH, Chan RC, Kao MJ, Cheng CK. Thermoregulatory sudomotor dysfunction and diabetic neuropathy develop in parallel in at-risk feet. Diabet Med. 2008 Apr;25(4):413-8. doi: 10.1111/j.1464-5491.2008.02395.x. Epub 2008 Mar 13.

Reference Type BACKGROUND
PMID: 18341593 (View on PubMed)

Turner G, Quigg S, Davoren P, Basile R, McAuley SA, Coombes JS. Resources to Guide Exercise Specialists Managing Adults with Diabetes. Sports Med Open. 2019 Jun 3;5(1):20. doi: 10.1186/s40798-019-0192-1.

Reference Type BACKGROUND
PMID: 31161377 (View on PubMed)

van Deursen RW, Simoneau GG. Foot and ankle sensory neuropathy, proprioception, and postural stability. J Orthop Sports Phys Ther. 1999 Dec;29(12):718-26. doi: 10.2519/jospt.1999.29.12.718.

Reference Type BACKGROUND
PMID: 10612069 (View on PubMed)

van Praag H, Shubert T, Zhao C, Gage FH. Exercise enhances learning and hippocampal neurogenesis in aged mice. J Neurosci. 2005 Sep 21;25(38):8680-5. doi: 10.1523/JNEUROSCI.1731-05.2005.

Reference Type BACKGROUND
PMID: 16177036 (View on PubMed)

Other Identifiers

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0151/65

Identifier Type: -

Identifier Source: org_study_id

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