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

NCT06578325 | Completed

• 1 other identifier: SPSC-9
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Kidney Disease

Keywords

Diabetic kidney disease; Cerebrovascular reactivity; Renal function; Thai dance meditation

Outcome Measures

Primary Outcomes (25)

• 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 Outcomes (13)

• Waist circumference

  Change from baseline waist circumference at 12 weeks]

• .Flexibility testing

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

• Muscle strength testing

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

• Muscle strength testing

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

• Balance testing

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

Study Arms (2)

Diabetes kidney disease patients with Thai dance meditation

EXPERIMENTAL

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

Diabetes kidney disease patients

SHAM COMPARATOR

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

Interventions

Thai dance meditation OTHER

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.

Diabetes kidney disease patients with Thai dance meditation

No intervention OTHER

No intervention

Diabetes kidney disease patients

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Daroonwan Suksom, Ph.D.

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Sports science

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 29, 2024
• Study Start: August 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)