Elderly With Type 2 DiabetesNCT05641090
Effects of Nordic Walking in Water on Cerebrovascular Function and Cognitive Impairment in Elderly With Type 2 Diabetes
A study testing Nordic walking in water and No exercise intervention in people with Elderly With Type 2 Diabetes, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Nordic walking in water would more advantage than normal daily life in cerebrovascular function and cognitive function in elderly with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 60 to 74 years
- Conditions the study is for
- Elderly With Type 2 Diabetes
- What is being tested?
- Nordic walking in water and No exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteThailand
- Study dates
- 16 Dec 2021to 5 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants were excluded if they dropped out or completed less than 80% of the training schedule
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Sports Science, Chulalongkorn University
Pathum Wan, Bangkok, 10330
Prof.Dr.Daroonwan Suksom, Ph.D, 6681-341-5736, Daroonwan.S@chula.ac.th
Prof.Dr.Daroonwan Suksom, Ph.D.
About this study
Nordic walking in water would more advantage than normal daily life in cerebrovascular function and cognitive function in elderly with type 2 diabetes.
- Conditions
- Elderly With Type 2 Diabetes
- Being tested
- Nordic walking in water, No exercise intervention
- Keywords
- Type 2 Diabetes mellitus, Cerebrovascular function, Cognitive impairment, Nordic walking in water, Physical fitness
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic walking in waterOther
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.
No exercise interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nordic walking in water | Experimental | The groups trained Nordic walking in water Receives: Other: Nordic walking in water; Other: No exercise intervention |
| No exercise intervention | No intervention | The groups did not receive exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
General physiological data
1.Blood pressure in mmHg will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Change from baseline Arterial compliance at 12 weeks.
Pulsatility index
Pulsatility index in units will be measure with ultrasonography equipment (EPIQ 5G, Phillips).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline Trail Making Test-B and Stroop test at 12 weeks.
Secondary outcomes (12)
Waist circumference
Waist circumference in centimeters will be measure by waist tape
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline time up and go at 12 weeks.
Cardiopulmonary fitness
Cardiopulmonary fitness will be measure by 2-minutes step test in repetitions.
Measured: Change from baseline 2-minutes step at 12 weeks.
Cardiopulmonary fitness
Cardiopulmonary fitness will be measure by 6-minutes walk test in meters.
Measured: 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.
Measured: Change from baseline fasting blood sugar at 12 weeks.
Glycosylated hemoglobin
Glycosylated hemoglobin in percent will be measure with enzymatic assay using hexokinase reaction.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline Nitric oxide at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start16 Dec 2021
- Primary completion30 Jan 2023 (estimated)
- Study completion5 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly With Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr.Daroonwan Suksom, Chulalongkorn University
- Investigators
- Daroonwan Suksom, Ph.D., Principal investigator, Faculty of Sport Science Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641090
- Sponsor's protocol ID
- SPSC-8
- Status last verified
- Nov 2022
- First submitted
- 14 Jul 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nordic Walking in Water on Cerebrovascular Function and Cognitive Impairment in Elderly With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05641090
- Acronym / sponsor ID
- SPSC-8
- Conditions
- Elderly With Type 2 Diabetes
- Keywords
- Type 2 Diabetes mellitus, Cerebrovascular function, Cognitive impairment, Nordic walking in water, Physical fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 5 Apr 2023 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nordic walking in water would more advantage than normal daily life in cerebrovascular function and cognitive function in elderly with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nordic walking in water | Experimental | Other: Nordic walking in water, Other: No exercise interventionThe groups trained Nordic walking in water |
| No exercise intervention | No intervention | –The groups did not receive exercise |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Participants were excluded if they dropped out or completed less than 80% of the training schedule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nordic walking in waterNordic 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 | Nordic walking in water |
| No exercise interventionThis 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. | Other | Nordic walking in water |
Primary outcome
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).
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).
ฺ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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
12 secondary outcomes
Waist circumference
Time frame: Change from baseline waist circumference at 12 weeks
Flexibility testing
Time frame: Change from baseline Chair sit & reach and Back scratch at 12 weeks.
Muscle strength testing
Time frame: Change from baseline arm-curl and chair stand at 12 weeks.
Balance testing
Time frame: Change from baseline time up and go at 12 weeks.
Cardiopulmonary fitness
Time frame: Change from baseline 2-minutes step at 12 weeks.
Cardiopulmonary fitness
Time frame: Change from baseline 6-minutes walk at 12 weeks.
Fasting blood sugar
Time frame: Change from baseline fasting blood sugar at 12 weeks.
Glycosylated hemoglobin
Time frame: Change from baseline Glycosylated hemoglobin at 12 weeks.
Homeostasis Model Assessment of insulin resistance
Time frame: Change from baseline Homeostasis Model Assessment of insulin resistance at 12 weeks.
Lipid profile
Time frame: 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
Time frame: Change from baseline tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde at 12 weeks.
Nitric oxide
Time frame: Change from baseline Nitric oxide at 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daroonwan Suksom, Ph.D. principal investigator
Faculty of Sport Science Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nordic walking in water and No exercise intervention in people with Elderly With Type 2 Diabetes, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daroonwan Suksom, Ph.D. (081-3415736, Daroonwan.S@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General physiological data (time frame: Change from baseline systolic blood pressure, diastolic blood pressure, and mean arterial pressure at 12 weeks.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.