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

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

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



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05641090


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

Locations
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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
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Principal Investigator: Daroonwan Suksom, Ph.D. Faculty of Sport Science Chulalongkorn University
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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    Key Record Dates
Last Update Posted: December 7, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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