Effects of Nordic Walking in Water on Cerebrovascular Function and Cognitive Impairment in Elderly With Type 2 Diabetes

Nordic walking in water would more advantage than normal daily life in cerebrovascular function and cognitive function in elderly with type 2 diabetes.

Study Overview

• Status: Recruiting
• Conditions: Elderly With Type 2 Diabetes
• Intervention / Treatment: Other: Nordic walking in water; Other: No exercise intervention

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daroonwan Suksom, Ph.D.; Phone Number: 081-3415736; Email: Daroonwan.S@chula.ac.th

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Recruiting
      • Faculty of Sports Science, Chulalongkorn University
      • Contact: Prof.Dr.Daroonwan Suksom, Ph.D; Phone Number: 6681-341-5736; Email: Daroonwan.S@chula.ac.th
      • Principal Investigator: Prof.Dr.Daroonwan Suksom, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The inclusion criteria included type 2 diabetes (as defined by the American Diabetes Association), a baseline glycosylated hemoglobin (HbA1c) value of 7-9%, and no previous exercise training in the past 6 months. All participants were free from diabetic nephropathy, diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases.
• Participants had Montreal Cognitive Assessment - Thai (MoCa-T) scores between 18 24 points.
• Participants had time up & go test between 8 - 15 seconds

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: Nordic walking in water; The groups trained Nordic walking in water	Other: Nordic walking in water; Nordic walking in water will be based on nordic walking in water at temperature 34◦C. Nordic walking in water will be conducted at moderate intensity (40-60% heart rate reserve). The program was exercised 60 minutes include warm-up and cool down. At first 6 weeks, The exercise intensity was 40-50% heart rate reserve and it will be increased 50-60% heart rate reserve. The training program will be performed 3 times per week for 12 weeks.; Other: No exercise intervention; This group wasn't receive intervention program. The participants in this group will do following a physician who treat them. They can exercise according to the physician recommend.
No Intervention: No exercise intervention; The groups did not receive exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General physiological data	1.Blood pressure in mmHg will be measured with automated blood pressure 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 device (CARESCAPE V100, GE Dinamap).	Change from baseline heart rate at 12 weeks.
ฺBody fat	Body fat in percent will be measured with dual energy x-ray absorptiometry (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 (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.
Cerebral blood flow	Cerebral blood flow in centimeter per second will be measured 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.
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 and Stroop test	Trail Making Test-B in second cut off below 101 seconds that indicate dementia. Stroop test in second will be measured with EncephalApp Stroop test.	Change from baseline Trail Making Test-B and Stroop test at 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	Waist circumference in centimeters 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 and Back scratch in centimeters.	Change from baseline Chair sit & reach and Back scratch 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 2-minutes step test in repetitions.	Change from baseline 2-minutes step 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.
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.
Lipid profile	Lipid profile will be measure by cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein in mg/dl.	Change from baseline cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein at 12 weeks.
Tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde	Tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde in pg/ml will be measure with ELISA assay kit.	Change from baseline tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde at 12 weeks.
Nitric oxide	Nitric oxide in µM will measured with standard Griess reagents.	Change from baseline Nitric oxide at 12 weeks.

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Daroonwan Suksom, Ph.D., Faculty of Sport Science Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Anticipated): January 30, 2023
• Study Completion (Anticipated): April 5, 2023

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Estimate): December 7, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Physical fitness; Cognitive impairment; Type 2 Diabetes mellitus; Cerebrovascular function; Nordic walking in water
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Neurocognitive Disorders; Endocrine System Diseases; Cognition Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Cognitive Dysfunction
• Other Study ID Numbers: SPSC-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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