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A Comparison of the Effect of Warm and Cold Water Exercise Training on Vascular Function in Type 2 Diabetic Patients

A Comparison of the Effect of Warm and Cold Water Exercise Training on Vascular Function in Type 2 Diabetic Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02551900
Enrollment
48
Registered
2015-09-16
Start date
2014-09-01
Completion date
2016-12-15
Last updated
2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes, Vascular Function, Water Exercise, Warm Water, Cold Water

Brief summary

Warm water based cycling exercise training would more favorable than cold water based cycling exercise training and land based cycling exercise in vascular function in type 2 diabetic patients.

Interventions

OTHERWarm water exercise

Warm water based cycling exercise training program will be based on cycling in warm water (temperature 34◦C ). Warm water exercise will be conducted at moderate intensity (60-70% maximum heart rate). The three groups were exercise 15 minutes on the first month, second month will be increased to 20 minutes and the last month will be increased to 30 minutes. The training program will be performed 3 times per week for 12 weeks.

OTHERCold water exercise

Cold water based cycling exercise training will be based on cycling in cold water (temperature 20◦C ). Cold water exercise will be conducted at moderate intensity (60-70% maximum heart rate). The three groups were exercise 15 minutes on the first month, second month will be increased to 20 minutes and the last month will be increased to 30 minutes. The training program will be performed 3 times per week for 12 weeks.

OTHERLand based cycling exercise

Land based cycling exercise training will be based on ride a bicycle ergometer (Monark 894e, Sweden). Land based cycling exercise training will be conducted at moderate intensity (60-70% maximum heart rate). The three groups were exercise 15 minutes on the first month, second month will be increased to 20 minutes and the last month will be increased to 30 minutes. The training program will be performed 3 times per week for 12 weeks.

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No

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.

Exclusion criteria

* Participants were excluded if they dropped out or completed less than 80% of the training schedule.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in glycemic controlBaseline, 12 weeksThe glycemic control will be quantified using blood samples. Fasting blood glucose, HbA1c, insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and C-reactive protein will be measured with standard procedures at the clinical laboratory (N health Lab, Samitivej, Sriracha, Thailand). Homeostasis model assessment (HOMA-IR will be calculated by using equation of \[Fasting glucose (mg/dL) × Insulin level (uU/mL) / 405\].
Change from baseline in vascular reactivityBaseline, 12 weeksVascular reactivity or brachial and popliteal artery flow-mediated dilatation (FMD) will be assessed with the ultrasound equipment (CX50, Philips, USA), using the blood occlusion technique on the right forearm and lower leg. The brachial artery and the popliteal artery will be imaged above the antecubital fossa in the longitudinal plane and proximal slightly above the popliteal fossa. Brachial FMD will be measured at baseline and the cuff placed around the right forearm will be inflated to 50 mmHg above systolic blood pressure for 5 minutes and then deflated for 5 minutes of recovery. While popliteal FMD will be measured at baseline and the cuff will be positioned on the lower right leg below the knee will be inflated to 250 mmHg for 5 minutes and then deflated for 5 minutes of recovery. FMD will be calculated from the formula FMD= (D2-D1)x100/D1 when D1 is the brachial or popliteal artery diameter at baseline, D2 is the maximal post-occlusion brachial or popliteal artery diameter.
Change from baseline in cutaneous blood flowBaseline, 12 weeksCutaneous blood flow will be determined by laser Doppler Flowmetry (DRT4, Moore Instrument, UK). Laser Doppler Flowmetry probes will be attached to the dorsum of middle fingertip and the dorsum of the foot. The occlusion cuffs will be placed around left middle upper arm and calf were inflated to a pressure of 50 mmHg above the systolic pressure and will be remained inflated for 3 minutes, after which it will be rapidly released, producing a brief high-flow state resulting in artery dilation due to increase shear stress. The peak Laser Doppler Flux (peak LDF) and after 5 min occlusion period will be recorded.

Secondary

MeasureTime frameDescription
Change from baseline in physical fitnessBaseline, 12 weeksBody composition will be measured using Body Composition Analyzer (Tanita BC-533, Japan)
Change from baseline in blood chemistryBaseline, 12 weeksNitric oxide (NO) will be measured in plasma samples with the commercial assay kit (Colorimetric nitric oxide assay kit, PromoKine, Germany).
Change from baseline in Peripheral arterial stiffnessBaseline, 12 weeksPulse wave velocity (brachial-ankle PWV) measurement will be assessed using Omron Colin VP1000 for measuring.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026