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Diabetic Kidney DiseaseNCT06578325

Effects of Thai Dance Meditation Exercise on Renal and Cerebrovascular Function in Elderly With Diabetic Kidney Disease

A study testing Thai dance meditation in people with Diabetic Kidney Disease, 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
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Trial summary

Elderly with diabetic kidney disease who practiced Thai dance meditation training more favorable adaptations than normal daily life in improving glycemic control, kidney function, vascular function and cerebrovascular function. Read more about this study

Who is it for?
Ages 60 to 75 years
Conditions the study is for
Diabetic Kidney Disease
What is being tested?
Thai dance meditation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteThailand
Study dates
15 Aug 2021to 31 Jul 2022
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

  • The inclusion criteria included diabetic kidney disease (DKD) (as defined by the KDIGO (Kidney Disease Improving Global Outcomes 2012), a baseline glycosylated hemoglobin (HbA1c) value of 7-9%, albumin-to creatinine ratio (ACR): A3 [>300 mg/day; ACR, >300 mg/g (>30 mg/mmol)], GFR category 3 (moderately decreased) has now been divided into categories G3a [45-59 mL/ min1 /(1.73m2) and G3b [30 -44 mL/ min1/(1.73 m2) which represent mildly to moderately decreased function and moderately to severely decreased function and no previous exercise training in the past 6 months.
  • All participants were free from diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases.
  • Participants had Montreal Cognitive Assessment - Thai (MoCa-T) scores between 18 24 points.
  • Not having uncontrolled high blood pressure (Systolic blood pressure; SBP) >159 mmHg and Diastolic blood pressure; DBP) > 99 mmHg

Who cannot join

  • Participants were excluded if they dropped out or completed less than 80% of the training schedule

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Faculty of Sports Science, Chulalongkorn University

    Pathum Wan, Bangkok, 10330

Other trials in Thailand

About this study

Elderly with diabetic kidney disease who practiced Thai dance meditation training more favorable adaptations than normal daily life in improving glycemic control, kidney function, vascular function and cerebrovascular function.

Read the detailed description

This cross-sectional study was to compare glycemic control, kidney function, vascular function, cerebrovascular function, physical fitness and quality of life between elderly with diabetic kidney disease who practiced Thai dance meditation training and normal daily life.

Being tested
Thai dance meditation, No intervention
Keywords
Diabetic kidney disease, Cerebrovascular reactivity, Renal function, Thai dance meditation
Medical subject headings
Diabetic Nephropathies

What participants receive

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

  • Thai dance meditationOther

    Thai dance meditation training program will be based on aerobic Thai dance exercise combined with Buddhist meditation. The participants will perform aerobic Thai dance meditation while concentrated on hand movements through counting the numbers 1 2 3 4 5 6 7 1 on the 1st round and continuing on the 2nd round, counting as 1 2 3 4 5 6 7 2…. Repeat for 8 rounds. Thai dance meditation will be conducted at mild to moderate intensity (40-60% heart rate reserve) and in phase 2 (week 7-12), the training intensity will be increased to moderate intensity (50-60% heart rate reserve). In both phases the training will be performed foe 50 minutes, 3 times per week.

  • No interventionOther

    No intervention

Study groups in NCT06578325
Study groupRoleWhat they receive
Diabetes kidney disease patients with Thai dance meditationExperimentalMale and female diabetic kidney disease patients were selected based on screening for diabetes and renal function. They were recruited for measurement of all variables in the study to compare with another group.
Receives: Other: Thai dance meditation
Diabetes kidney disease patientsSham comparatorMale and female diabetic kidney disease patients were not training Thai dance meditation. They were recruited for measurement of all variables in the study to compare with another group.
Receives: Other: No intervention

What is being measured

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

  1. Blood pressure

    Blood pressure (systolic blood pressure, diastolic blood pressure, and mean arterial pressure) in mmHg will be measured with automated blood pressure in mmHg device (CARESCAPE V100, GE Dinamap).

    Measured: Change from baseline systolic blood pressure, diastolic blood pressure, and mean arterial pressure at 12 weeks.]

  2. Heart rate

    Heart rate in beats per minute will be measured with automated blood pressure in beat per minute device (CARESCAPE V100, GE Dina map).

    Measured: Change from baseline heart rate at 12 weeks

  3. Body fat

    Body fat in percent will be measured with dual energy x-ray absorptiometry in percent (Prodigy-Pro, GE healthcare).

    Measured: Change from baseline body fat at 12 weeks

  4. Muscle mass and Weight

    Muscle mass and weight in kilograms will be measured with dual energy x-ray absorptiometry in kilogram (Prodigy-Pro, GE healthcare).

    Measured: Change from baseline muscle mass and weight at 12 weeks.

  5. Arterial stiffness

    Arterial stiffness will be measured with brachial-ankle pulse wave velocity in centimeter per second (VP-1000 plus, omrom Healthcare).

    Measured: Change from baseline brachial-ankle pulse wave velocity at 12 weeks

  6. Macro vascular function

    Macro vascular function will be measured by brachial artery flow-mediated dilatation in percent with ultrasonography equipment EPIQ 5G, Phillips.

    Measured: Change from baseline brachial artery flow-mediated dilatation at 12 weeks

  7. Renal function

    Blood urea nitrogen (BUN) in milligram per deciliter will be measure by Kinetic test with urease and glutamate dehydrogenase with urease/glutamate dehydrogenase coupled enzymatic (Coupled enzymes)

    Measured: Change from baseline Blood urea nitrogen at 12 weeks.

  8. Intrarenal artery

    Intrarenal artery will be measured by renal blood flow in renal arterial resistive index (RI) with ultrasonography equipment EPIQ 5G, Phillips.

    Measured: Change from baseline renal arterial resistive index (RI) at 12 weeks.

  9. Post Occlusive Reactive Hyperemia; PORH

    Evaluation of blood flow to the skin area in percent will be measured by Post Occlusive Reactive Hyperemia in percent; PORH with Laser Doppler flowmeter, Perimed AB, Sweden.

    Measured: Change from baseline Post Occlusive Reactive Hyperemia; PORH at 12 weeks.

  10. Cerebral blood flow

    Cerebral blood flow in centimeter per second will be measure with ultrasonography equipment (EPIQ 5G, Phillips).

    Measured: Change from baseline cerebral blood flow at 12 weeks

  11. Cerebrovascular conductance index

    Cerebrovascular conductance index in cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips).

    Measured: Change from baseline cerebrovascular conductance index at 12 weeks

  12. Cerebrovascular reactivity index

    Cerebrovascular reactivity index in %cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips).

    Measured: Change from baseline cerebrovascular reactivity index at 12 weeks

  13. Arterial compliance

    Arterial compliance in units will be measure by carotid diameter during systolic and diastolic with ultrasonography equipment (EPIQ 5G, Phillips) and systemic blood pressure with (VP-1000 plus, omrom Healthcare).

    Measured: Change from baseline Arterial compliance at 12 weeks

  14. Pulsatility index

    Pulsatility index in units will be measure with ultrasonography equipment (EPIQ 5G, Phillips).

    Measured: Change from baseline Pulsatility index at 12 weeks.] 12.Montreal Cognitive Assessment

  15. Montreal Cognitive Assessment

    Montreal Cognitive Assessment in score (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function.

    Measured: Change from baseline Montreal Cognitive Assessment at 12 weeks.]

  16. Mini-Mental State Examination

    Mini-Mental State Examination in scores (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function.

    Measured: Change from baseline Mini-Mental State Examination at 12 weeks.]

  17. Trail Making Test-B

    Trail Making Test-B in second cut off below 101 seconds that indicate dementia.

    Measured: Change from baseline Trail Making Test-B at 12 weeks

  18. Fasting blood sugar

    Fasting blood sugar in mg/dl will be measure with enzymatic assay using hexokinase reaction.

    Measured: Change from baseline fasting blood sugar at 12 weeks.]

  19. Glycosylated hemoglobin

    Glycosylated hemoglobin in percent will be measure with enzymatic assay using hexokinase reaction.

    Measured: Change from baseline Glycosylated hemoglobin at 12 weeks.]

  20. Homeostasis Model Assessment of insulin resistance

    Homeostasis Model Assessment of insulin resistance in units will be calculated with Fasting blood sugar and insulin.

    Measured: Change from baseline Homeostasis Model Assessment of insulin resistance at 12 weeks.]

  21. Creatinine

    Creatinine in mg/dl will be measure with enzymatic assay

    Measured: Change from baseline creatinine at 12 weeks.]

  22. estimate Glomerular filtration rate

    estimate Glomerular filtration rate in ml/min/1.73 m2 will be calculated by CKD-EPI formular according to National kidney foundation recommendation.

    Measured: Change from baseline estimate Glomerular filtration rate at 12 weeks.]

  23. Cystatin C

    Cystatin C in mg/L will be measure with particle enhanced Immunoturbidimetric assay

    Measured: Change from baseline blood urea nitrogen at 12 weeks

  24. Urine albumin creatinine ratio

    Urine albumin creatinine ratio will be measure with Immunoturbidimetric assay

    Measured: Change from baseline urine albumin creatinine ratio at 12 weeks.

  25. Stroop test

    Stroop test in second will be measured with EncephalApp - Stroop Test

    Measured: Change from baseline Stroop test in second at 12 weeks.

Secondary outcomes (13)
  1. Waist circumference

    Waist circumference in inch will be measure by waist tape

    Measured: Change from baseline waist circumference at 12 weeks]

  2. .Flexibility testing

    Flexibility testing will be measure by Chair sit \& reach protocol in centimeters.

    Measured: Change from baseline Chair sit & reach at 12 weeks.]

  3. Muscle strength testing

    Muscle strength testing will be measured by arm-curl test repetitions in 30 seconds

    Measured: Change from baseline arm-curl and chair stand at 12 weeks.]

  4. Muscle strength testing

    Muscle strength testing will be measured by arm-curl test and chair stand test in repetitions in 30 seconds

    Measured: Change from baseline arm-curl and chair stand at 12 weeks.]

  5. Balance testing

    Balance testing will be measured by time up and go testing in seconds.

    Measured: Change from baseline time up and go at 12 weeks.]

  6. Cardiopulmonary fitness

    Cardiopulmonary fitness will be measure by 6-minutes walk test in meters.

    Measured: Change from baseline 6-minutes walk at 12 weeks.]

  7. Lipid profile

    Lipid profile will be measure by cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein in mg/dl.

    Measured: Change from baseline Nitric oxide at 12 weeks.] cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein at 12 weeks.]

  8. Interleukin-6 (IL-6), Tumor necrosis factor-alpha (TNF- α), Brain derived neurotrophic factor, Malondialdehyde, Superoxide Dismutase.

    Interleukin-6 (IL-6), Tumor necrosis factor-alpha (TNF- α), Brain derived neurotrophic factor, Malondialdehyde, Superoxide Dismutase in pg/ml will be measure with ELISA assay kit.

    Measured: Change from baselineInterleukin-6 (IL-6), Tumor necrosis factor-alpha (TNF- α), Brain derived neurotrophic factor, Malondialdehyde, Superoxide Dismutase. at 12 weeks.]

  9. Nitric oxide

    Nitric oxide in µM will measured with standard Griess reagents.

    Measured: Change from baseline Nitric oxide at 12 weeks.

  10. Quality of life in patients with chronic kidney disease

    Quality of life will be measured by SF-36 questionnaire for evaluation of Quality of Life in patients with chronic kidney disease. The scores of questionnaires were 75-100 points for good quality of life, 50-75 points for moderate quality of life, 25-50 points for low quality of life and 0-25 points for very low quality of life.

    Measured: Change from baseline at 12 weeks.

  11. Flexibility testing

    Flexibility testing will be measure by back scratch in centimeters.

    Measured: Change from baseline back scratch at 12 weeks.

  12. Muscle strength testing

    Muscle strength testing will be measured by chair stand test in repetitions in 30 seconds

    Measured: Change from baseline chair stand at 12 weeks.]

  13. Body mass index (BMI)

    Body mass index (BMI) through height and weight measurement by body composition analyzer weight and height will be combined to report BMI in kg/m^2.

    Measured: Change from baseline BMI at 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 Aug 2024
  2. Study start15 Aug 2021
  3. Primary completion30 Jun 2022
  4. Study completion31 Jul 2022

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
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06578325
Sponsor's protocol ID
SPSC-9
Status last verified
Aug 2024
First submitted
18 Aug 2024
Last updated
29 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Thai dance meditation in people with Diabetic Kidney Disease, 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 4 inclusion and 1 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 29 Aug 2024. 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. Some participants in this study may receive a placebo. 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?

Blood pressure (time frame: Change from baseline systolic blood pressure, diastolic blood pressure, and mean arterial pressure at 12 weeks.]). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Aug 2024.

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