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

Primary Purpose

Elderly With Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Nordic walking in water
No exercise intervention
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elderly With Type 2 Diabetes focused on measuring Type 2 Diabetes mellitus, Cerebrovascular function, Cognitive impairment, Nordic walking in water, Physical fitness

Eligibility Criteria

60 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Sports Science, Chulalongkorn UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nordic walking in water

No exercise intervention

Arm Description

The groups trained Nordic walking in water

The groups did not receive exercise

Outcomes

Primary Outcome Measures

General physiological data
1.Blood pressure in mmHg will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).
Heart rate
Heart rate in beats per minute will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).
ฺBody fat
Body fat in percent will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcare).
Muscle mass and Weight
Muscle mass and weight in kilograms will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcare).
Arterial stiffness
Arterial stiffness will be measured with brachial-ankle pulse wave velocity in centimeter per second (VP-1000 plus, omrom Healthcare).
Macro vascular function
Macro vascular function will be measured by brachial artery flow-mediated dilatation in percent with ultrasonography equipment (EPIQ 5G, Phillips).
Cerebral blood flow
Cerebral blood flow in centimeter per second will be measured with ultrasonography equipment (EPIQ 5G, Phillips).
Cerebrovascular conductance index
Cerebrovascular conductance index in cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips).
Cerebrovascular reactivity index
Cerebrovascular reactivity index in %cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips).
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).
Pulsatility index
Pulsatility index in units will be measure with ultrasonography equipment (EPIQ 5G, Phillips).
Montreal Cognitive Assessment
Montreal Cognitive Assessment in score (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function.
Mini-Mental State Examination
Mini-Mental State Examination in scores (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function.
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.

Secondary Outcome Measures

Waist circumference
Waist circumference in centimeters will be measure by waist tape
Flexibility testing
Flexibility testing will be measure by Chair sit & reach protocol and Back scratch in centimeters.
Muscle strength testing
Muscle strength testing will be measured by arm-curl test and chair stand test in repetitions in 30 seconds.
Balance testing
Balance testing will be measured by time up and go testing in seconds.
Cardiopulmonary fitness
Cardiopulmonary fitness will be measure by 2-minutes step test in repetitions.
Cardiopulmonary fitness
Cardiopulmonary fitness will be measure by 6-minutes walk test in meters.
Fasting blood sugar
Fasting blood sugar in mg/dl will be measure with enzymatic assay using hexokinase reaction.
Glycosylated hemoglobin
Glycosylated hemoglobin in percent will be measure with enzymatic assay using hexokinase reaction.
Homeostasis Model Assessment of insulin resistance
Homeostasis Model Assessment of insulin resistance in units will be calculated with Fasting blood sugar and insulin.
Lipid profile
Lipid profile will be measure by cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein in mg/dl.
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.
Nitric oxide
Nitric oxide in µM will measured with standard Griess reagents.

Full Information

First Posted
July 14, 2022
Last Updated
November 29, 2022
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT05641090
Brief Title
Effects of Nordic Walking in Water on Cerebrovascular Function and Cognitive Impairment in Elderly With Type 2 Diabetes
Official Title
Effects of Nordic Walking in Water on Cerebrovascular Function and Cognitive Impairment in Elderly With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
April 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly With Type 2 Diabetes
Keywords
Type 2 Diabetes mellitus, Cerebrovascular function, Cognitive impairment, Nordic walking in water, Physical fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nordic walking in water
Arm Type
Experimental
Arm Description
The groups trained Nordic walking in water
Arm Title
No exercise intervention
Arm Type
No Intervention
Arm Description
The groups did not receive exercise
Intervention Type
Other
Intervention Name(s)
Nordic walking in water
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No exercise intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
General physiological data
Description
1.Blood pressure in mmHg will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).
Time Frame
Change from baseline systolic blood pressure, diastolic blood pressure, and mean arterial pressure at 12 weeks.
Title
Heart rate
Description
Heart rate in beats per minute will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).
Time Frame
Change from baseline heart rate at 12 weeks.
Title
ฺBody fat
Description
Body fat in percent will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcare).
Time Frame
Change from baseline body fat at 12 weeks.
Title
Muscle mass and Weight
Description
Muscle mass and weight in kilograms will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcare).
Time Frame
Change from baseline muscle mass and weight at 12 weeks.
Title
Arterial stiffness
Description
Arterial stiffness will be measured with brachial-ankle pulse wave velocity in centimeter per second (VP-1000 plus, omrom Healthcare).
Time Frame
Change from baseline brachial-ankle pulse wave velocity at 12 weeks.
Title
Macro vascular function
Description
Macro vascular function will be measured by brachial artery flow-mediated dilatation in percent with ultrasonography equipment (EPIQ 5G, Phillips).
Time Frame
Change from baseline brachial artery flow-mediated dilatation at 12 weeks.
Title
Cerebral blood flow
Description
Cerebral blood flow in centimeter per second will be measured with ultrasonography equipment (EPIQ 5G, Phillips).
Time Frame
Change from baseline cerebral blood flow at 12 weeks.
Title
Cerebrovascular conductance index
Description
Cerebrovascular conductance index in cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips).
Time Frame
Change from baseline cerebrovascular conductance index at 12 weeks.
Title
Cerebrovascular reactivity index
Description
Cerebrovascular reactivity index in %cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips).
Time Frame
Change from baseline cerebrovascular reactivity index at 12 weeks.
Title
Arterial compliance
Description
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).
Time Frame
Change from baseline Arterial compliance at 12 weeks.
Title
Pulsatility index
Description
Pulsatility index in units will be measure with ultrasonography equipment (EPIQ 5G, Phillips).
Time Frame
Change from baseline Pulsatility index at 12 weeks.
Title
Montreal Cognitive Assessment
Description
Montreal Cognitive Assessment in score (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function.
Time Frame
Change from baseline Montreal Cognitive Assessment at 12 weeks.
Title
Mini-Mental State Examination
Description
Mini-Mental State Examination in scores (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function.
Time Frame
Change from baseline Mini-Mental State Examination at 12 weeks.
Title
Trail Making Test-B and Stroop test
Description
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.
Time Frame
Change from baseline Trail Making Test-B and Stroop test at 12 weeks.
Secondary Outcome Measure Information:
Title
Waist circumference
Description
Waist circumference in centimeters will be measure by waist tape
Time Frame
Change from baseline waist circumference at 12 weeks
Title
Flexibility testing
Description
Flexibility testing will be measure by Chair sit & reach protocol and Back scratch in centimeters.
Time Frame
Change from baseline Chair sit & reach and Back scratch at 12 weeks.
Title
Muscle strength testing
Description
Muscle strength testing will be measured by arm-curl test and chair stand test in repetitions in 30 seconds.
Time Frame
Change from baseline arm-curl and chair stand at 12 weeks.
Title
Balance testing
Description
Balance testing will be measured by time up and go testing in seconds.
Time Frame
Change from baseline time up and go at 12 weeks.
Title
Cardiopulmonary fitness
Description
Cardiopulmonary fitness will be measure by 2-minutes step test in repetitions.
Time Frame
Change from baseline 2-minutes step at 12 weeks.
Title
Cardiopulmonary fitness
Description
Cardiopulmonary fitness will be measure by 6-minutes walk test in meters.
Time Frame
Change from baseline 6-minutes walk at 12 weeks.
Title
Fasting blood sugar
Description
Fasting blood sugar in mg/dl will be measure with enzymatic assay using hexokinase reaction.
Time Frame
Change from baseline fasting blood sugar at 12 weeks.
Title
Glycosylated hemoglobin
Description
Glycosylated hemoglobin in percent will be measure with enzymatic assay using hexokinase reaction.
Time Frame
Change from baseline Glycosylated hemoglobin at 12 weeks.
Title
Homeostasis Model Assessment of insulin resistance
Description
Homeostasis Model Assessment of insulin resistance in units will be calculated with Fasting blood sugar and insulin.
Time Frame
Change from baseline Homeostasis Model Assessment of insulin resistance at 12 weeks.
Title
Lipid profile
Description
Lipid profile will be measure by cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein in mg/dl.
Time Frame
Change from baseline cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein at 12 weeks.
Title
Tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde
Description
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.
Time Frame
Change from baseline tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde at 12 weeks.
Title
Nitric oxide
Description
Nitric oxide in µM will measured with standard Griess reagents.
Time Frame
Change from baseline Nitric oxide at 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daroonwan Suksom, Ph.D.
Phone
081-3415736
Email
Daroonwan.S@chula.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daroonwan Suksom, Ph.D.
Organizational Affiliation
Faculty of Sport Science Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Sports Science, Chulalongkorn University
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof.Dr.Daroonwan Suksom, Ph.D
Phone
6681-341-5736
Email
Daroonwan.S@chula.ac.th
First Name & Middle Initial & Last Name & Degree
Prof.Dr.Daroonwan Suksom, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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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