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High-intensity Interval Training Training Protocols on Cardiorespiratory Parameters in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03487029
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Cemile Bozdemir Ozel, Hacettepe University

Brief 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.


Condition or disease Intervention/treatment Phase
Diabetes Other: Short duration Other: Long duration Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Different High-intensity Interval Training Training Protocols on Cardiorespiratory Parameters in Patients With Type 2 Diabetes
Actual Study Start Date : March 2, 2018
Estimated Primary Completion Date : September 20, 2018
Estimated Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: short duration group
30sn %100 Wmax 120sn %25 Wmax 3 sessions/week total 8 weeks
Other: Short duration
exercise Short duration high intensity training
Other Name: training

Experimental: long duration group
4dk %85 Wmax 120sn %25 Wmax 3 sessions/week total 8 weeks
Other: Long duration
exercise Long duration high intensity training
Other Name: training




Primary Outcome Measures :
  1. muscle oxigeneration [ Time Frame: Change from baseline muscle oxigeneration at 8 weeks ]
    It is evaluate with wearable lactate threshold device on gastrocinemius


Secondary Outcome Measures :
  1. The blood glucose consentration [ Time Frame: before and after 8 weeks ]
    It is evaluate with sample from blood

  2. Functional Exercise capacity [ Time Frame: before and after 8 weeks ]
    İt is evaluated with six minute walk test

  3. Maximal exercise capacity [ Time Frame: before and after 8 weeks ]
    İt is evaluated using with incremental shuttle test

  4. Symptom limited maximal exercise capacity [ Time Frame: before and after 8 weeks ]
    İt is evaluated with cycle ergometer test

  5. Lipit profile-High density lipoprotein cholesterol [ Time Frame: before and after 8 weeks ]
    High density lipoprotein cholesterol wiil be assesed

  6. Lipit profile- low density lipoprotein cholesterol [ Time Frame: before and after 8 weeks ]
    low density lipoprotein cholesterol wiil be assesed

  7. Lipit profile- trigliseride [ Time Frame: before and after 8 weeks ]
    trigliseride wiil be assesed

  8. pulmonary parameter-Forced vital capacity [ Time Frame: before and after 8 weeks ]
    Forced vital capacity will be evaluated

  9. pulmonary parameter-Forced vital capacity in the first second [ Time Frame: before and after 8 weeks ]
    Forced vital capacity in the first second will be evaluated

  10. pulmonary parameter-Mid expiratory flow rate [ Time Frame: before and after 8 weeks ]
    Mid expiratory flow rate will be evaluated

  11. pulmonary parameter-Peak expiratory flow [ Time Frame: before and after 8 weeks ]
    Peak expiratory flow will be evaluated

  12. Respiratory muscle strength [ Time Frame: before and after 8 weeks ]
    It is evaluated with mouth pressure

  13. Physical activity level [ Time Frame: before and after 8 weeks ]
    ıt is assessed using accelerometer

  14. Quality of life [ Time Frame: before and after 8 weeks ]
    ıt will be evaluated with Diabetes Quality of Life



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487029


Contacts
Contact: cemile bozdemir ozel 0905352138084 cemilebozdemir@hotmail.com

Locations
Turkey
Hacettepe University Recruiting
Ankara, State, Turkey, 06100
Contact: cemile bozdemir özel    0905352138084    cemilebozdemir@hotmail.com   
Sponsors and Collaborators
Hacettepe University
Investigators
Principal Investigator: Cemile Bozdemir Özel, McS Hacettepe University Physiotherapy and Rehabilitation

Responsible Party: Cemile Bozdemir Ozel, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03487029     History of Changes
Other Study ID Numbers: KA17069
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cemile Bozdemir Ozel, Hacettepe University:
diabetes
high intensity interval training
cardiorespiratory fitness

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases