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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Kidney Disease
• Intervention / Treatment: Other: No intervention; Other: Thai dance meditation

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Faculty of Sports Science, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetes kidney disease patients with Thai dance meditation; Male 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.	Other: Thai dance meditation; 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.
Sham Comparator: Diabetes kidney disease patients; Male 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.	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Change from baseline systolic blood pressure, diastolic blood pressure, and mean arterial pressure at 12 weeks.]
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).	Change from baseline heart rate at 12 weeks
Body fat	Body fat in percent will be measured with dual energy x-ray absorptiometry in percent (Prodigy-Pro, GE healthcare).	Change from baseline body fat at 12 weeks
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).	Change from baseline muscle mass and weight at 12 weeks.
Arterial stiffness	Arterial stiffness will be measured with brachial-ankle pulse wave velocity in centimeter per second (VP-1000 plus, omrom Healthcare).	Change from baseline brachial-ankle pulse wave velocity at 12 weeks
Macro vascular function	Macro vascular function will be measured by brachial artery flow-mediated dilatation in percent with ultrasonography equipment EPIQ 5G, Phillips.	Change from baseline brachial artery flow-mediated dilatation at 12 weeks
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)	Change from baseline Blood urea nitrogen at 12 weeks.
Intrarenal artery	Intrarenal artery will be measured by renal blood flow in renal arterial resistive index (RI) with ultrasonography equipment EPIQ 5G, Phillips.	Change from baseline renal arterial resistive index (RI) at 12 weeks.
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.	Change from baseline Post Occlusive Reactive Hyperemia; PORH at 12 weeks.
Cerebral blood flow	Cerebral blood flow in centimeter per second will be measure with ultrasonography equipment (EPIQ 5G, Phillips).	Change from baseline cerebral blood flow at 12 weeks
Cerebrovascular conductance index	Cerebrovascular conductance index in cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips).	Change from baseline cerebrovascular conductance index at 12 weeks
Cerebrovascular reactivity index	Cerebrovascular reactivity index in %cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips).	Change from baseline cerebrovascular reactivity index at 12 weeks
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).	Change from baseline Arterial compliance at 12 weeks
Pulsatility index	Pulsatility index in units will be measure with ultrasonography equipment (EPIQ 5G, Phillips).	Change from baseline Pulsatility index at 12 weeks.] 12.Montreal Cognitive Assessment
Montreal Cognitive Assessment	Montreal Cognitive Assessment in score (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function.	Change from baseline Montreal Cognitive Assessment at 12 weeks.]
Mini-Mental State Examination	Mini-Mental State Examination in scores (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function.	Change from baseline Mini-Mental State Examination at 12 weeks.]
Trail Making Test-B	Trail Making Test-B in second cut off below 101 seconds that indicate dementia.	Change from baseline Trail Making Test-B at 12 weeks
Fasting blood sugar	Fasting blood sugar in mg/dl will be measure with enzymatic assay using hexokinase reaction.	Change from baseline fasting blood sugar at 12 weeks.]
Glycosylated hemoglobin	Glycosylated hemoglobin in percent will be measure with enzymatic assay using hexokinase reaction.	Change from baseline Glycosylated hemoglobin at 12 weeks.]
Homeostasis Model Assessment of insulin resistance	Homeostasis Model Assessment of insulin resistance in units will be calculated with Fasting blood sugar and insulin.	Change from baseline Homeostasis Model Assessment of insulin resistance at 12 weeks.]
Creatinine	Creatinine in mg/dl will be measure with enzymatic assay	Change from baseline creatinine at 12 weeks.]
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.	Change from baseline estimate Glomerular filtration rate at 12 weeks.]
Cystatin C	Cystatin C in mg/L will be measure with particle enhanced Immunoturbidimetric assay	Change from baseline blood urea nitrogen at 12 weeks
Urine albumin creatinine ratio	Urine albumin creatinine ratio will be measure with Immunoturbidimetric assay	Change from baseline urine albumin creatinine ratio at 12 weeks.
Stroop test	Stroop test in second will be measured with EncephalApp - Stroop Test	Change from baseline Stroop test in second at 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nitric oxide	Nitric oxide in µM will measured with standard Griess reagents.	Change from baseline Nitric oxide at 12 weeks.
Waist circumference	Waist circumference in inch will be measure by waist tape	Change from baseline waist circumference at 12 weeks]
.Flexibility testing	Flexibility testing will be measure by Chair sit & reach protocol in centimeters.	Change from baseline Chair sit & reach at 12 weeks.]
Muscle strength testing	Muscle strength testing will be measured by arm-curl test repetitions in 30 seconds	Change from baseline arm-curl and chair stand at 12 weeks.]
Muscle strength testing	Muscle strength testing will be measured by arm-curl test and chair stand test in repetitions in 30 seconds	Change from baseline arm-curl and chair stand at 12 weeks.]
Balance testing	Balance testing will be measured by time up and go testing in seconds.	Change from baseline time up and go at 12 weeks.]
Cardiopulmonary fitness	Cardiopulmonary fitness will be measure by 6-minutes walk test in meters.	Change from baseline 6-minutes walk at 12 weeks.]
Lipid profile	Lipid profile will be measure by cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein in mg/dl.	Change from baseline Nitric oxide at 12 weeks.] cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein at 12 weeks.]
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.	Change from baselineInterleukin-6 (IL-6), Tumor necrosis factor-alpha (TNF- α), Brain derived neurotrophic factor, Malondialdehyde, Superoxide Dismutase. at 12 weeks.]
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.	Change from baseline at 12 weeks.
Flexibility testing	Flexibility testing will be measure by back scratch in centimeters.	Change from baseline back scratch at 12 weeks.
Muscle strength testing	Muscle strength testing will be measured by chair stand test in repetitions in 30 seconds	Change from baseline chair stand at 12 weeks.]
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.	Change from baseline BMI at 12 weeks.

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Daroonwan Suksom, Ph.D., Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: August 18, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Diabetic kidney disease; Renal function; Cerebrovascular reactivity; Thai dance meditation
• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: SPSC-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No