DiabetesNCT03487029
High-intensity Interval Training Training Protocols on Cardiorespiratory Parameters in Patients With Type 2 Diabetes
A study testing Short duration and Long duration in people with Diabetes, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Short duration and Long duration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2018to 17 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of type 2 diabetes
- aged 18-64 years
- patients can walk and cooperative
- body mass index is less than 40 kg / m2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read more
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.
- Conditions
- Diabetes
- Being tested
- Short duration, Long duration
- Keywords
- diabetes, high intensity interval training, cardiorespiratory fitness
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short durationOther
Also called training
exercise Short duration high intensity training
Long durationOther
Also called training
exercise Long duration high intensity training
| Study group | Role | What they receive |
|---|---|---|
| short duration group | Experimental | 30sn %100 Wmax 120sn %25 Wmax 3 sessions/week total 8 weeks Receives: Other: Short duration |
| long duration group | Experimental | 4dk %85 Wmax 120sn %25 Wmax 3 sessions/week total 8 weeks Receives: Other: Long duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle oxigeneration
It is evaluate with wearable lactate threshold device on gastrocinemius
Measured: Change from baseline muscle oxigeneration at 8 weeks
Secondary outcomes (13)
The blood glucose consentration
It is evaluate with sample from blood
Measured: before and after 8 weeks
Functional Exercise capacity
İt is evaluated with six minute walk test
Measured: before and after 8 weeks
Maximal exercise capacity
İt is evaluated using with incremental shuttle test
Measured: before and after 8 weeks
Symptom limited maximal exercise capacity
İt is evaluated with cycle ergometer test
Measured: before and after 8 weeks
Lipit profile-High density lipoprotein cholesterol
High density lipoprotein cholesterol wiil be assesed
Measured: before and after 8 weeks
Lipit profile- low density lipoprotein cholesterol
low density lipoprotein cholesterol wiil be assesed
Measured: before and after 8 weeks
Lipit profile- trigliseride
trigliseride wiil be assesed
Measured: before and after 8 weeks
pulmonary parameter-Forced vital capacity
Forced vital capacity will be evaluated
Measured: before and after 8 weeks
pulmonary parameter-Forced vital capacity in the first second
Forced vital capacity in the first second will be evaluated
Measured: before and after 8 weeks
pulmonary parameter-Mid expiratory flow rate
Mid expiratory flow rate will be evaluated
Measured: before and after 8 weeks
pulmonary parameter-Peak expiratory flow
Peak expiratory flow will be evaluated
Measured: before and after 8 weeks
Respiratory muscle strength
It is evaluated with mouth pressure
Measured: before and after 8 weeks
Physical activity level
ıt is assessed using accelerometer
Measured: before and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start2 Mar 2018
- Primary completion20 Sep 2018
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemile Bozdemir Ozel, Hacettepe University
- Investigators
- Cemile Bozdemir Özel, McS, Principal investigator, Hacettepe University Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487029
- Sponsor's protocol ID
- KA17069
- Status last verified
- Apr 2020
- First submitted
- 6 Feb 2018
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different High-intensity Interval Training Training Protocols on Cardiorespiratory Parameters in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03487029
- Acronym / sponsor ID
- KA17069
- Conditions
- Diabetes
- Keywords
- diabetes, high intensity interval training, cardiorespiratory fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short duration group | Experimental | Other: Short duration30sn %100 Wmax 120sn %25 Wmax 3 sessions/week total 8 weeks |
| long duration group | Experimental | Other: Long duration4dk %85 Wmax 120sn %25 Wmax 3 sessions/week total 8 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- diagnosis of type 2 diabetes
- aged 18-64 years
- patients can walk and cooperative
- body mass index is less than 40 kg / m2
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short durationAlso: trainingexercise Short duration high intensity training | Other | short duration group |
| Long durationAlso: trainingexercise Long duration high intensity training | Other | long duration group |
Primary outcome
muscle oxigeneration
Time frame: Change from baseline muscle oxigeneration at 8 weeks
It is evaluate with wearable lactate threshold device on gastrocinemius
13 secondary outcomes
The blood glucose consentration
Time frame: before and after 8 weeks
Functional Exercise capacity
Time frame: before and after 8 weeks
Maximal exercise capacity
Time frame: before and after 8 weeks
Symptom limited maximal exercise capacity
Time frame: before and after 8 weeks
Lipit profile-High density lipoprotein cholesterol
Time frame: before and after 8 weeks
Lipit profile- low density lipoprotein cholesterol
Time frame: before and after 8 weeks
Lipit profile- trigliseride
Time frame: before and after 8 weeks
pulmonary parameter-Forced vital capacity
Time frame: before and after 8 weeks
pulmonary parameter-Forced vital capacity in the first second
Time frame: before and after 8 weeks
pulmonary parameter-Mid expiratory flow rate
Time frame: before and after 8 weeks
pulmonary parameter-Peak expiratory flow
Time frame: before and after 8 weeks
Respiratory muscle strength
Time frame: before and after 8 weeks
Physical activity level
Time frame: before and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cemile Bozdemir Özel, McS principal investigator
Hacettepe University Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short duration and Long duration in people with Diabetes, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle oxigeneration (time frame: Change from baseline muscle oxigeneration at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.