Type 2 DiabetesNCT02551900
A Comparison of the Effect of Warm and Cold Water Exercise Training on Vascular Function in Type 2 Diabetic Patients
A study testing Warm water exercise, Cold water exercise and Land based cycling exercise in people with Type 2 Diabetes, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Warm water exercise, Cold water exercise and Land based cycling exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2014to 15 Dec 2016
- 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 75 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.
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
Laemchabang stadium, Sukhumvit Rd
Si Racha, Changwat Chon Buri, 20230
About this study
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Warm water exercise, Cold water exercise, Land based cycling exercise
- Keywords
- Type 2 Diabetes, Vascular Function, Water Exercise, Warm Water, Cold Water
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm water exerciseOther
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 exerciseOther
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.
Land based cycling exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Warm water exercise & Cold water exercise | Experimental | Not described Receives: Other: Warm water exercise; Other: Cold water exercise |
| Warm water exercise & Land cycling exercise | Active comparator | Not described Receives: Other: Warm water exercise; Other: Land based cycling exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in glycemic control
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].
Measured: Baseline, 12 weeks
Change from baseline in vascular reactivity
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.
Measured: Baseline, 12 weeks
Change from baseline in cutaneous blood flow
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.
Measured: Baseline, 12 weeks
Secondary outcomes (8)
Change from baseline in physical fitness
Body composition will be measured using Body Composition Analyzer (Tanita BC-533, Japan)
Measured: Baseline, 12 weeks
Change from baseline in physical fitness
Lower muscle strength will be measured with leg dynamometer (Tokyo, Japan).
Measured: Baseline, 12 weeks
Change from baseline in physical fitness
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.
Measured: Baseline, 12 weeks
Change from baseline in physical fitness
Pulmonary function will be measured by spirometer ((MIR-Spirobank G)
Measured: Baseline, 12 weeks
Change from baseline in blood chemistry
Nitric oxide (NO) will be measured in plasma samples with the commercial assay kit (Colorimetric nitric oxide assay kit, PromoKine, Germany).
Measured: Baseline, 12 weeks
Change from baseline in blood chemistry
Malondialdehyde (MDA) will be determined using thiobarbituric acid reaction.
Measured: Baseline, 12 weeks
Change from baseline in blood chemistry
C-reactive protein will be measured with standard procedures at the clinical laboratory (N health Lab, Samitivej, Sriracha, Thailand).
Measured: Baseline, 12 weeks
Change from baseline in Peripheral arterial stiffness
Pulse wave velocity (brachial-ankle PWV) measurement will be assessed using Omron Colin VP1000 for measuring.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start1 Sep 2014
- Primary completion15 Sep 2015
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. 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
- NCT02551900
- Sponsor's protocol ID
- SPSC-4
- Status last verified
- Apr 2018
- First submitted
- 15 Sep 2015
- Last updated
- 4 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effect of Warm and Cold Water Exercise Training on Vascular Function in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02551900
- Acronym / sponsor ID
- SPSC-4
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Vascular Function, Water Exercise, Warm Water, Cold Water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Sep 2014
- Primary completion
- 15 Sep 2015 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 16 Sep 2015 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm water exercise & Cold water exercise | Experimental | Other: Warm water exercise, Other: Cold water exercise |
| Warm water exercise & Land cycling exercise | Active comparator | Other: Warm water exercise, Other: Land based cycling exercise |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 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.
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 |
|---|---|---|
| Warm water exerciseWarm 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. | Other | Warm water exercise & Cold water exercise, Warm water exercise & Land cycling exercise |
| Cold water exerciseCold 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. | Other | Warm water exercise & Cold water exercise |
| Land based cycling exerciseLand 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. | Other | Warm water exercise & Land cycling exercise |
Primary outcome
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].
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.
Change from baseline in cutaneous blood flow
Time frame: Baseline, 12 weeks
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.
8 secondary outcomes
Change from baseline in physical fitness
Time frame: Baseline, 12 weeks
Change from baseline in physical fitness
Time frame: Baseline, 12 weeks
Change from baseline in physical fitness
Time frame: Baseline, 12 weeks
Change from baseline in physical fitness
Time frame: Baseline, 12 weeks
Change from baseline in blood chemistry
Time frame: Baseline, 12 weeks
Change from baseline in blood chemistry
Time frame: Baseline, 12 weeks
Change from baseline in blood chemistry
Time frame: Baseline, 12 weeks
Change from baseline in Peripheral arterial stiffness
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
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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 Warm water exercise, Cold water exercise and Land based cycling exercise in people 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 1 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: finished, as of the sponsor's last update on 4 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in glycemic control (time frame: Baseline, 12 weeks). The study lists 3 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 4 Apr 2018.