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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03487029
Other study ID # KA17069
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2, 2018
Est. completion date January 17, 2020

Study information

Verified date April 2020
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim: To assess whether there are different training effects on glucose concentration and cardiorespiratory parameters of different high-intensity training protocols in patients with type 2 diabetes.

Type 2 diabetes is a highly prevalent disease associated with cardiovascular disease leading to high levels of mortality, morbidity and health expenditure, characterized by impaired glucose control during activities and reduced aerobic exercise capacity .

Exercise training is the most effective way to improve compliance, reduce blood glucose concentration and increase insulin sensitivity. Training increases muscle capacity, oxidative capacity and glucose transport, peripheral insulin sensitivity is improved.

Exercise training with high-intensity interval (resting and exercise period) High Intensity Interval Training (HIIT) is a form of exercise training that has recently been widely used in the management of type 2 diabetes, including short duration high intensity exercise periods and lower severity or passive rest periods. There are different HIIT exercise training programs according to physiological responses in the literature. However, long-term and short-term HIIT training training programs were not compared in terms of their effect on glucose concentration and cardiorespiratory fitness. The aim of this study was to compare the effects of different HIIT exercise training programs so that exercise programs for patients with type 2 diabetes could be planned more effectively.


Description:

This study will be participated patients with Type 2 diabetes. Patients' laboratory values, pulmonary function test, respiratory muscle strength, exercise capacity, physical activity level, quality of life will be evaluated.

Pulmonary function test will be assesed with spirometer, respiratory muscle strength will be evaluated with mouth pressure. Exercise capacity will be evaluated using six minute walking test, incremental shuttle walk test, cycle ergometer. Muscle oxigeneration will be asssed with wearable lactate threshold predicting device. Physical activity level will be evaluated trial accelerometer.

Then, patients will be randomly divided two high intensity interval exercise training groups.

First group: short duration high intensity exercise training (Exercise load phase : 30sn %100 Patients performance, rest phase: 120sn %25 patients performance) Second group: Long duration high intensity interval exercise training (Exercise load phase : 4 dk %100 Patients performance, rest phase: 120sn %25 patients performance) All patients will participate three times a week during eight weeks. The muscle oxigeneration, blood glucose consantration, blood pressure, heart rate will be recorded before and after each exercise session. After 8 week, all test will be done again.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date January 17, 2020
Est. primary completion date September 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- diagnosis of type 2 diabetes

- aged 18-64 years

- patients can walk and cooperative

- body mass index is less than 40 kg / m2

Exclusion Criteria:

Individuals have known lung disease,have undergone any cardiac event or surgery within the past six months, have uncontrolled hypertension, and have diabetic complications such as nephropathy, retinopathy and severe neuropathy.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Short duration
exercise Short duration high intensity training
Long duration
exercise Long duration high intensity training

Locations

Country Name City State
Turkey Hacettepe University Ankara State

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary muscle oxigeneration It is evaluate with wearable lactate threshold device on gastrocinemius Change from baseline muscle oxigeneration at 8 weeks
Secondary The blood glucose consentration It is evaluate with sample from blood before and after 8 weeks
Secondary Functional Exercise capacity It is evaluated with six minute walk test before and after 8 weeks
Secondary Maximal exercise capacity It is evaluated using with incremental shuttle test before and after 8 weeks
Secondary Symptom limited maximal exercise capacity It is evaluated with cycle ergometer test before and after 8 weeks
Secondary Lipit profile-High density lipoprotein cholesterol High density lipoprotein cholesterol wiil be assesed before and after 8 weeks
Secondary Lipit profile- low density lipoprotein cholesterol low density lipoprotein cholesterol wiil be assesed before and after 8 weeks
Secondary Lipit profile- trigliseride trigliseride wiil be assesed before and after 8 weeks
Secondary pulmonary parameter-Forced vital capacity Forced vital capacity will be evaluated before and after 8 weeks
Secondary pulmonary parameter-Forced vital capacity in the first second Forced vital capacity in the first second will be evaluated before and after 8 weeks
Secondary pulmonary parameter-Mid expiratory flow rate Mid expiratory flow rate will be evaluated before and after 8 weeks
Secondary pulmonary parameter-Peak expiratory flow Peak expiratory flow will be evaluated before and after 8 weeks
Secondary Respiratory muscle strength It is evaluated with mouth pressure before and after 8 weeks
Secondary Physical activity level it is assessed using accelerometer before and after 8 weeks
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