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

• ClinicalTrials.gov Identifier: NCT05641090
• Recruitment Status: Recruiting
• First Posted: December 7, 2022
• Last Update Posted: December 7, 2022
• Sponsor: Chulalongkorn University
• Information provided by (Responsible Party): Prof. Dr.Daroonwan Suksom, Chulalongkorn University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Elderly With Type 2 Diabetes	Other: Nordic walking in water; Other: No exercise intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Nordic Walking in Water on Cerebrovascular Function and Cognitive Impairment in Elderly With Type 2 Diabetes
• Actual Study Start Date: December 16, 2021
• Estimated Primary Completion Date: January 30, 2023
• Estimated Study Completion Date: April 5, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. General physiological data [ Time Frame: Change from baseline systolic blood pressure, diastolic blood pressure, and mean arterial pressure at 12 weeks. ]
   1.Blood pressure in mmHg will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).
2. Heart rate [ Time Frame: Change from baseline heart rate at 12 weeks. ]
   Heart rate in beats per minute will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).
3. ฺBody fat [ Time Frame: Change from baseline body fat at 12 weeks. ]
   Body fat in percent will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcare).
4. Muscle mass and Weight [ Time Frame: Change from baseline muscle mass and weight at 12 weeks. ]
   Muscle mass and weight in kilograms will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcare).
5. Arterial stiffness [ Time Frame: Change from baseline brachial-ankle pulse wave velocity at 12 weeks. ]
   Arterial stiffness will be measured with brachial-ankle pulse wave velocity in centimeter per second (VP-1000 plus, omrom Healthcare).
6. Macro vascular function [ Time Frame: Change from baseline brachial artery flow-mediated dilatation at 12 weeks. ]
   Macro vascular function will be measured by brachial artery flow-mediated dilatation in percent with ultrasonography equipment (EPIQ 5G, Phillips).
7. Cerebral blood flow [ Time Frame: Change from baseline cerebral blood flow at 12 weeks. ]
   Cerebral blood flow in centimeter per second will be measured with ultrasonography equipment (EPIQ 5G, Phillips).
8. Cerebrovascular conductance index [ Time Frame: Change from baseline cerebrovascular conductance index at 12 weeks. ]
   Cerebrovascular conductance index in cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips).
9. Cerebrovascular reactivity index [ Time Frame: Change from baseline cerebrovascular reactivity index at 12 weeks. ]
   Cerebrovascular reactivity index in %cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips).
10. Arterial compliance [ Time Frame: Change from baseline Arterial compliance at 12 weeks. ]
    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).
11. Pulsatility index [ Time Frame: Change from baseline Pulsatility index at 12 weeks. ]
    Pulsatility index in units will be measure with ultrasonography equipment (EPIQ 5G, Phillips).
12. Montreal Cognitive Assessment [ Time Frame: Change from baseline Montreal Cognitive Assessment at 12 weeks. ]
    Montreal Cognitive Assessment in score (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function.
13. Mini-Mental State Examination [ Time Frame: Change from baseline Mini-Mental State Examination at 12 weeks. ]
    Mini-Mental State Examination in scores (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function.
14. Trail Making Test-B and Stroop test [ Time Frame: Change from baseline Trail Making Test-B and Stroop test at 12 weeks. ]
    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.

Secondary Outcome Measures :

1. Waist circumference [ Time Frame: Change from baseline waist circumference at 12 weeks ]
   Waist circumference in centimeters will be measure by waist tape
2. Flexibility testing [ Time Frame: Change from baseline Chair sit & reach and Back scratch at 12 weeks. ]
   Flexibility testing will be measure by Chair sit & reach protocol and Back scratch in centimeters.
3. Muscle strength testing [ Time Frame: Change from baseline arm-curl and chair stand at 12 weeks. ]
   Muscle strength testing will be measured by arm-curl test and chair stand test in repetitions in 30 seconds.
4. Balance testing [ Time Frame: Change from baseline time up and go at 12 weeks. ]
   Balance testing will be measured by time up and go testing in seconds.
5. Cardiopulmonary fitness [ Time Frame: Change from baseline 2-minutes step at 12 weeks. ]
   Cardiopulmonary fitness will be measure by 2-minutes step test in repetitions.
6. Cardiopulmonary fitness [ Time Frame: Change from baseline 6-minutes walk at 12 weeks. ]
   Cardiopulmonary fitness will be measure by 6-minutes walk test in meters.
7. Fasting blood sugar [ Time Frame: Change from baseline fasting blood sugar at 12 weeks. ]
   Fasting blood sugar in mg/dl will be measure with enzymatic assay using hexokinase reaction.
8. Glycosylated hemoglobin [ Time Frame: Change from baseline Glycosylated hemoglobin at 12 weeks. ]
   Glycosylated hemoglobin in percent will be measure with enzymatic assay using hexokinase reaction.
9. Homeostasis Model Assessment of insulin resistance [ Time Frame: Change from baseline Homeostasis Model Assessment of insulin resistance at 12 weeks. ]
   Homeostasis Model Assessment of insulin resistance in units will be calculated with Fasting blood sugar and insulin.
10. Lipid profile [ Time Frame: Change from baseline cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein at 12 weeks. ]
    Lipid profile will be measure by cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein in mg/dl.
11. Tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde [ Time Frame: Change from baseline tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde at 12 weeks. ]
    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.
12. Nitric oxide [ Time Frame: Change from baseline Nitric oxide at 12 weeks. ]
    Nitric oxide in µM will measured with standard Griess reagents.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Daroonwan Suksom, Ph.D.; 081-3415736; Daroonwan.S@chula.ac.th

Locations

Thailand

Faculty of Sports Science, Chulalongkorn University; Recruiting

Pathum Wan, Bangkok, Thailand, 10330

Contact: Prof.Dr.Daroonwan Suksom, Ph.D 6681-341-5736 Daroonwan.S@chula.ac.th

Principal Investigator: Prof.Dr.Daroonwan Suksom, Ph.D.

Sponsors and Collaborators

Chulalongkorn University

Investigators

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

More Information

• Responsible Party: Prof. Dr.Daroonwan Suksom, Principal Investigator, Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT05641090
• Other Study ID Numbers: SPSC-8
• First Posted: December 7, 2022
• Last Update Posted: December 7, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr.Daroonwan Suksom, Chulalongkorn University:

Type 2 Diabetes mellitus; Cerebrovascular function; Cognitive impairment; Nordic walking in water; Physical fitness

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Cognitive Dysfunction; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders