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.
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.
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
- The control group was advised to exercise at home for a period of 12 weeks.
- 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.
- Conditions
- Exercise Addiction, Diabetic Neuropathies
- 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 group | Role | What they receive |
|---|---|---|
| Aerobic Thai dance exercise intervention | Experimental | Aerobic Thai dance exercise 60 minute per times, 3 times per weeks of 12 weeks. Receives: Other: Aerobic Thai dance exercise |
| Control | No intervention | Give advice on exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
Gait Speed will be measured by Strideway in centimeter per seconds (cm/sec).
Measured: Baseline and 12 weeks
Step length
Step length will be measured by Strideway in centimeter (cm).
Measured: Baseline and 12 weeks
Single Support
Single Support will be measured by Strideway in seconds (sec).
Measured: Baseline and 12 weeks
Double Support
Double Support will be measured by Strideway in seconds (sec).
Measured: Baseline and 12 weeks
Cadence
Cadence will be measured by Strideway in steps per minute (steps/minute).
Measured: Baseline and 12 weeks
Postural Stability Testing
Postural Stability Testing will be measured by Biodex balance system in score.
Measured: 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.
Measured: Baseline and 12 weeks
Limits of Stability (LOS)
Limits of Stability (LOS) will be measured by Biodex balance system in score.
Measured: Baseline and 12 weeks
Time up and go test
Functional balance test will be measured by Time up and go test in seconds.
Measured: Baseline and 12 weeks
Functional reach test
Functional balance test will be measured by Functional reach test in centimeter.
Measured: Baseline and 12 weeks
Secondary outcomes (19)
Sudomotor function
Sudomotor function testing feet and hands will be measured by Sudoscan in microsiemens (µS).
Measured: Baseline and 12 weeks
Leg muscle strength
Leg muscle strength testing will be measured by Isokinetic dynamometer in newton meter (Nm).
Measured: Baseline and 12 weeks
Ankle muscle strength
Ankle Muscle strength testing will be measured by Hand-held dynamometry in kilogram (Kg).
Measured: Baseline and 12 weeks
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
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
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
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
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
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
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
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
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
Blood pressure
Blood pressure will be measured by Sphygmomanometer in mmHg.
Measured: Baseline and 12 weeks
Resting heart rate
Resting heart rate will be measured by Sphygmomanometer in Times per minute (Times/ minute).
Measured: Baseline and 12 weeks
Weight
Weight will be measured by Body Composition Analyzer in kilogram (kg).
Measured: Baseline and 12 weeks
Height
Height will be measured by Body Composition Analyzer in centimeter (cm).
Measured: Baseline and 12 weeks
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
Body fat
Body fat index will be measured by Dexa Scan in percentage.
Measured: Baseline and 12 weeks
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.
- First posted29 Sep 2023
- Study start19 Sep 2022
- Primary completion20 Oct 2022
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Exercise AddictionStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thammarat Koksungnoen, Chulalongkorn University
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 10388962Ahn 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 22985218Akbari 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 22773533Alam 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 28864841Albright 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 10912903Baker 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 31608304Billot 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 23305721Booya 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 16336693Borkosky 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 22396832Casellini 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 23889506Chatterton 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 24180324Chen 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 22064493Chyun 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 16581898Colberg 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 27926890Cox 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Thai Dance on Gait, Balance and Sudomotor Function in Patient With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06061237
- Acronym / sponsor ID
- 0151/65
- Conditions
- Exercise Addiction, Diabetic Neuropathies
- Keywords
- Diabetes Mellitus, Diabetic Peripheral Neuropathy, Thai Dance, Gait, Balance, Sudomotor Function, DPN, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- The control group was advised to exercise at home for a period of 12 weeks.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Thai dance exercise intervention | Experimental | Other: Aerobic Thai dance exerciseAerobic Thai dance exercise 60 minute per times, 3 times per weeks of 12 weeks. |
| Control | No intervention | –Give advice on exercise. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Thai dance exerciseAerobic Thai dance exercise 60 minute per times, 3 times per weeks of 12 weeks. Aerobic exercise of modulate intensity (12-13 Borg's RPE) | Other | Aerobic Thai dance exercise intervention |
Primary outcome
Gait Speed
Time frame: Baseline and 12 weeks
Gait Speed will be measured by Strideway in centimeter per seconds (cm/sec).
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).
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.
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.
Limits of Stability (LOS)
Time frame: Baseline and 12 weeks
Limits of Stability (LOS) will be measured by Biodex balance system in score.
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.
Functional reach test
Time frame: Baseline and 12 weeks
Functional balance test will be measured by Functional reach test in centimeter.
19 secondary outcomes
Sudomotor function
Time frame: Baseline and 12 weeks
Leg muscle strength
Time frame: Baseline and 12 weeks
Ankle muscle strength
Time frame: Baseline and 12 weeks
Michigan Neuropathy Screening Instrument (MNSI)
Time frame: Baseline and 12 weeks
Short-form McGill Pain Questionnaire (SF-MPQ)
Time frame: Baseline and 12 weeks
Neurological symptom score (NSS)
Time frame: Baseline and 12 weeks
Foot Pain Manikin
Time frame: Baseline and 12 weeks
Falls Efficacy Scale International (FES-I)
Time frame: Baseline and 12 weeks
Fasting Plasma Glucose (FPG)
Time frame: Baseline and 12 weeks
Hemoglobin A1c (HbA1C)
Time frame: Baseline and 12 weeks
High Density Lipoprotein (HDL)
Time frame: Baseline and 12 weeks
Low Density Lipoprotein (LDL)
Time frame: Baseline and 12 weeks
Blood pressure
Time frame: Baseline and 12 weeks
Resting heart rate
Time frame: Baseline and 12 weeks
Weight
Time frame: Baseline and 12 weeks
Height
Time frame: Baseline and 12 weeks
Body mass index (BMI)
Time frame: Baseline and 12 weeks
Body fat
Time frame: Baseline and 12 weeks
Muscle mass
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 10388962Adler 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.
- Background: PubMed 22985218Ahn 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.
- Background: PubMed 22773533Akbari 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.
- Background: PubMed 28864841Alam 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.
- Background: PubMed 10912903Albright 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.
- Background: PubMed 31608304Baker 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.
- Background: PubMed 23305721Billot 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.
- Background: PubMed 16336693Booya 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.
- Background: PubMed 22396832Borkosky 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.
- Background: PubMed 23889506Casellini 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.
- Background: PubMed 24180324Chatterton 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.
- Background: PubMed 22064493Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.