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

• ClinicalTrials.gov Identifier: NCT03487029
• Recruitment Status: Completed
• First Posted: April 3, 2018
• Last Update Posted: April 9, 2020
• Sponsor: Hacettepe University
• Information provided by (Responsible Party): Cemile Bozdemir Ozel, Hacettepe University

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 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
• Actual Primary Completion Date: September 20, 2018
• Actual Study Completion Date: January 17, 2020

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Turkey

Hacettepe University

Ankara, State, Turkey, 06100

Sponsors and Collaborators

Hacettepe University

Investigators

• Principal Investigator: Cemile Bozdemir Özel, McS; Hacettepe University Physiotherapy and Rehabilitation

More Information

• Responsible Party: Cemile Bozdemir Ozel, Principal Investigator, Hacettepe University
• ClinicalTrials.gov Identifier: NCT03487029
• Other Study ID Numbers: KA17069
• First Posted: April 3, 2018
• Last Update Posted: April 9, 2020
• Last Verified: April 2020

• 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; Oxymetazoline; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Nasal Decongestants; Vasoconstrictor Agents; Respiratory System Agents