- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03487029
High-intensity Interval Training Training Protocols on Cardiorespiratory Parameters in Patients With Type 2 Diabetes
The Effects of Different High-intensity Interval Training Training Protocols on Cardiorespiratory Parameters in Patients With Type 2 Diabetes
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
State
-
Ankara, State, Turkey, 06100
- Hacettepe University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: short duration group
30sn %100 Wmax 120sn %25 Wmax 3 sessions/week total 8 weeks
|
exercise Short duration high intensity training
Other Names:
|
|
EXPERIMENTAL: long duration group
4dk %85 Wmax 120sn %25 Wmax 3 sessions/week total 8 weeks
|
exercise Long duration high intensity training
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
muscle oxigeneration
Time Frame: Change from baseline muscle oxigeneration at 8 weeks
|
It is evaluate with wearable lactate threshold device on gastrocinemius
|
Change from baseline muscle oxigeneration at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The blood glucose consentration
Time Frame: before and after 8 weeks
|
It is evaluate with sample from blood
|
before and after 8 weeks
|
|
Functional Exercise capacity
Time Frame: before and after 8 weeks
|
İt is evaluated with six minute walk test
|
before and after 8 weeks
|
|
Maximal exercise capacity
Time Frame: before and after 8 weeks
|
İt is evaluated using with incremental shuttle test
|
before and after 8 weeks
|
|
Symptom limited maximal exercise capacity
Time Frame: before and after 8 weeks
|
İt is evaluated with cycle ergometer test
|
before and after 8 weeks
|
|
Lipit profile-High density lipoprotein cholesterol
Time Frame: before and after 8 weeks
|
High density lipoprotein cholesterol wiil be assesed
|
before and after 8 weeks
|
|
Lipit profile- low density lipoprotein cholesterol
Time Frame: before and after 8 weeks
|
low density lipoprotein cholesterol wiil be assesed
|
before and after 8 weeks
|
|
Lipit profile- trigliseride
Time Frame: before and after 8 weeks
|
trigliseride wiil be assesed
|
before and after 8 weeks
|
|
pulmonary parameter-Forced vital capacity
Time Frame: before and after 8 weeks
|
Forced vital capacity will be evaluated
|
before and after 8 weeks
|
|
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
|
before and after 8 weeks
|
|
pulmonary parameter-Mid expiratory flow rate
Time Frame: before and after 8 weeks
|
Mid expiratory flow rate will be evaluated
|
before and after 8 weeks
|
|
pulmonary parameter-Peak expiratory flow
Time Frame: before and after 8 weeks
|
Peak expiratory flow will be evaluated
|
before and after 8 weeks
|
|
Respiratory muscle strength
Time Frame: before and after 8 weeks
|
It is evaluated with mouth pressure
|
before and after 8 weeks
|
|
Physical activity level
Time Frame: before and after 8 weeks
|
ıt is assessed using accelerometer
|
before and after 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cemile Bozdemir Özel, McS, Hacettepe University Physiotherapy and Rehabilitation
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Nasal Decongestants
- Oxymetazoline
Other Study ID Numbers
- KA17069
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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