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CompletedNCT03487029Updated Apr 9, 2020

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

An interventional study of Short duration and Long duration in Diabetes, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-04-09.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes

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Keywords

  • diabetes
  • high intensity interval training
  • cardiorespiratory fitness
03

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    short duration group

    30sn %100 Wmax 120sn %25 Wmax 3 sessions/week total 8 weeks

    Other: Short duration

  • Experimental
    long duration group

    4dk %85 Wmax 120sn %25 Wmax 3 sessions/week total 8 weeks

    Other: Long duration

Interventions

  • OtherShort duration

    exercise Short duration high intensity training

    Also known as: training

  • OtherLong duration

    exercise Long duration high intensity training

    Also known as: training

05

What researchers measure

Primary outcomes

  1. muscle oxigeneration

    It is evaluate with wearable lactate threshold device on gastrocinemius

    Time frame: Change from baseline muscle oxigeneration at 8 weeks

Secondary outcomes

  1. The blood glucose consentration

    It is evaluate with sample from blood

    Time frame: before and after 8 weeks

  2. Functional Exercise capacity

    İt is evaluated with six minute walk test

    Time frame: before and after 8 weeks

  3. Maximal exercise capacity

    İt is evaluated using with incremental shuttle test

    Time frame: before and after 8 weeks

  4. Symptom limited maximal exercise capacity

    İt is evaluated with cycle ergometer test

    Time frame: before and after 8 weeks

  5. Lipit profile-High density lipoprotein cholesterol

    High density lipoprotein cholesterol wiil be assesed

    Time frame: before and after 8 weeks

  6. Lipit profile- low density lipoprotein cholesterol

    low density lipoprotein cholesterol wiil be assesed

    Time frame: before and after 8 weeks

  7. Lipit profile- trigliseride

    trigliseride wiil be assesed

    Time frame: before and after 8 weeks

  8. pulmonary parameter-Forced vital capacity

    Forced vital capacity will be evaluated

    Time frame: before and after 8 weeks

  9. pulmonary parameter-Forced vital capacity in the first second

    Forced vital capacity in the first second will be evaluated

    Time frame: before and after 8 weeks

  10. pulmonary parameter-Mid expiratory flow rate

    Mid expiratory flow rate will be evaluated

    Time frame: before and after 8 weeks

  11. pulmonary parameter-Peak expiratory flow

    Peak expiratory flow will be evaluated

    Time frame: before and after 8 weeks

  12. Respiratory muscle strength

    It is evaluated with mouth pressure

    Time frame: before and after 8 weeks

  13. Physical activity level

    ıt is assessed using accelerometer

    Time frame: before and after 8 weeks

06

Study locations

1 site
  • Hacettepe University
    Ankara, State 06100, Turkey
07

Registry details

Key details

Study ID
NCT03487029
Lead sponsor
Hacettepe University
Responsible party
Cemile Bozdemir Ozel (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Apr 3, 2018
Start date
Mar 2, 2018
Primary completion
Sep 20, 2018
Completion
Jan 17, 2020
Last update
Apr 9, 2020

Study contacts

Cemile Bozdemir Özel, McS
principal investigator · Hacettepe University Physiotherapy and Rehabilitation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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