Clinical trial NCT05641090: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly With Type 2 Diabetes
Keywords: Type 2 Diabetes mellitus
Cerebrovascular function
Cognitive impairment
Nordic walking in water
Physical fitness
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: General physiological data
timeFrame: Change from baseline systolic blood pressure, diastolic blood pressure, and mean arterial pressure at 12 weeks.
measure: Heart rate
timeFrame: Change from baseline heart rate at 12 weeks.
measure: ฺBody fat
timeFrame: Change from baseline body fat at 12 weeks.
measure: Muscle mass and Weight
timeFrame: Change from baseline muscle mass and weight at 12 weeks.
measure: Arterial stiffness
timeFrame: Change from baseline brachial-ankle pulse wave velocity at 12 weeks.
measure: Macro vascular function
timeFrame: Change from baseline brachial artery flow-mediated dilatation at 12 weeks.
measure: Cerebral blood flow
timeFrame: Change from baseline cerebral blood flow at 12 weeks.
measure: Cerebrovascular conductance index
timeFrame: Change from baseline cerebrovascular conductance index at 12 weeks.
measure: Cerebrovascular reactivity index
timeFrame: Change from baseline cerebrovascular reactivity index at 12 weeks.
measure: Arterial compliance
timeFrame: Change from baseline Arterial compliance at 12 weeks.
measure: Pulsatility index
timeFrame: Change from baseline Pulsatility index at 12 weeks.
measure: Montreal Cognitive Assessment
timeFrame: Change from baseline Montreal Cognitive Assessment at 12 weeks.
measure: Mini-Mental State Examination
timeFrame: Change from baseline Mini-Mental State Examination at 12 weeks.
measure: Trail Making Test-B and Stroop test
timeFrame: Change from baseline Trail Making Test-B and Stroop test at 12 weeks.
Secondary outcomes:
measure: Waist circumference
timeFrame: Change from baseline waist circumference at 12 weeks
measure: Flexibility testing
timeFrame: Change from baseline Chair sit & reach and Back scratch at 12 weeks.
measure: Muscle strength testing
timeFrame: Change from baseline arm-curl and chair stand at 12 weeks.
measure: Balance testing
timeFrame: Change from baseline time up and go at 12 weeks.
measure: Cardiopulmonary fitness
timeFrame: Change from baseline 2-minutes step at 12 weeks.
measure: Cardiopulmonary fitness
timeFrame: Change from baseline 6-minutes walk at 12 weeks.
measure: Fasting blood sugar
timeFrame: Change from baseline fasting blood sugar at 12 weeks.
measure: Glycosylated hemoglobin
timeFrame: Change from baseline Glycosylated hemoglobin at 12 weeks.
measure: Homeostasis Model Assessment of insulin resistance
timeFrame: Change from baseline Homeostasis Model Assessment of insulin resistance at 12 weeks.
measure: Lipid profile
timeFrame: Change from baseline cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein at 12 weeks.
measure: Tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde
timeFrame: Change from baseline tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde at 12 weeks.
measure: Nitric oxide
timeFrame: Change from baseline Nitric oxide at 12 weeks.
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Faculty of Sports Science, Chulalongkorn University
state: Bangkok
Study officials:
affiliation: Faculty of Sport Science Chulalongkorn University
name: Daroonwan Suksom, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: