- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02551900
A Comparison of the Effect of Warm and Cold Water Exercise Training on Vascular Function in Type 2 Diabetic Patients
April 3, 2018 updated by: Assoc. Prof. Dr.Daroonwan Suksom, Chulalongkorn University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chon Buri
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Si Racha, Chon Buri, Thailand, 20230
- Laemchabang stadium, Sukhumvit Rd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Warm water exercise & Cold 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.
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.
|
Active Comparator: Warm water exercise & Land cycling 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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in glycemic control
Time Frame: Baseline, 12 weeks
|
The 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].
|
Baseline, 12 weeks
|
Change from baseline in vascular reactivity
Time Frame: Baseline, 12 weeks
|
Vascular 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.
|
Baseline, 12 weeks
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Change from baseline in cutaneous blood flow
Time Frame: Baseline, 12 weeks
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Cutaneous 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.
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Baseline, 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in physical fitness
Time Frame: Baseline, 12 weeks
|
Body composition will be measured using Body Composition Analyzer (Tanita BC-533, Japan)
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Baseline, 12 weeks
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Change from baseline in physical fitness
Time Frame: Baseline, 12 weeks
|
Lower muscle strength will be measured with leg dynamometer (Tokyo, Japan).
|
Baseline, 12 weeks
|
Change from baseline in physical fitness
Time Frame: Baseline, 12 weeks
|
Maximal oxygen consumption (VO2peak) will be assessed by bicycle ergometer (Monark: 824e, Sweden).
Initial work load was 50 watt and increased stepwise by 25 W every 2 minutes (as measured using respiratory gas analyzer: Metamax 3B, Germany) until the subjects were no longer able to continue exercising.
|
Baseline, 12 weeks
|
Change from baseline in physical fitness
Time Frame: Baseline, 12 weeks
|
Pulmonary function will be measured by spirometer ((MIR-Spirobank G)
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Baseline, 12 weeks
|
Change from baseline in blood chemistry
Time Frame: Baseline, 12 weeks
|
Nitric oxide (NO) will be measured in plasma samples with the commercial assay kit (Colorimetric nitric oxide assay kit, PromoKine, Germany).
|
Baseline, 12 weeks
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Change from baseline in blood chemistry
Time Frame: Baseline, 12 weeks
|
Malondialdehyde (MDA) will be determined using thiobarbituric acid reaction.
|
Baseline, 12 weeks
|
Change from baseline in blood chemistry
Time Frame: Baseline, 12 weeks
|
C-reactive protein will be measured with standard procedures at the clinical laboratory (N health Lab, Samitivej, Sriracha, Thailand).
|
Baseline, 12 weeks
|
Change from baseline in Peripheral arterial stiffness
Time Frame: Baseline, 12 weeks
|
Pulse wave velocity (brachial-ankle PWV) measurement will be assessed using Omron Colin VP1000 for measuring.
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Baseline, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daroonwan Suksom, Ph.D., Faculty of Sport Science Chulalongkorn University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
September 15, 2015
Study Completion (Actual)
December 15, 2016
Study Registration Dates
First Submitted
September 15, 2015
First Submitted That Met QC Criteria
September 15, 2015
First Posted (Estimate)
September 16, 2015
Study Record Updates
Last Update Posted (Actual)
April 4, 2018
Last Update Submitted That Met QC Criteria
April 3, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPSC-4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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