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

NCT02551900 | Completed

• 1 other identifier: SPSC-4
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 \[Fasting glucose (mg/dL) × Insulin level (uU/mL) / 405\].

  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.

  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.

  Baseline, 12 weeks

Secondary Outcomes (8)

• Change from baseline in physical fitness

  Baseline, 12 weeks

• Change from baseline in physical fitness

  Baseline, 12 weeks

• Change from baseline in physical fitness

  Baseline, 12 weeks

• Change from baseline in physical fitness

  Baseline, 12 weeks

• Change from baseline in blood chemistry

  Baseline, 12 weeks

Study Arms (2)

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

Interventions

Warm water exercise OTHER

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.

Warm water exercise & Cold water exercise; Warm water exercise & Land cycling exercise

Cold water exercise OTHER

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.

Warm water exercise & Cold water exercise

Land based cycling exercise OTHER

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.

Warm water exercise & Land cycling exercise

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Laemchabang stadium, Sukhumvit Rd

Si Racha, Changwat Chon Buri, 20230, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Daroonwan Suksom, Ph.D.

  Faculty of Sport Science Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Sport Science

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 16, 2015
• Study Start: September 1, 2014
• Primary Completion: September 15, 2015
• Study Completion: December 15, 2016
• Last Updated: April 4, 2018

Record last verified: 2018-04

Locations

TH (1)