Type-2 DiabetesNCT04330911
The Effects of Aerobic Exercises on Exercise Capacity in Type-2 Diabetes Mellitus
A study testing Aerobic Exercise in people with Type-2 Diabetes, run by Emresenocak at 1 site in Turkey (Türkiye).
Trial summary
Diabetes, beyond glycemic control, is a complex chronic disease that requires continuous medical care with multifactorial risk reduction strategies. It is necessary to reduce the likelihood of complications and additional problems that may develop in the long term. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type-2 Diabetes
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 May 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with type-2 diabetes mellitus,
- patients who have sedentary lifestyle (<3 bouts of exercise per week and <30 minutes aerobic exercise period),
- non-smoking patients,
- not to lose more than 5% of total body weight in the last 6 months,
- blood pressure<160/100 mmHg
Who cannot join
- alcohol addiction in the last 12 months,
- patients who use insulin hormone,
- patients who have neuropathy or retinopathy,
- patients who have an acute cardiac event in the last 6 weeks,
- patients who have a disease at least 2 weeks in the last 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Supervised Exercise Programs on Exercise Capacity and Pulmonary Capacity in Type-2 Diabetic Patients
Diabetes, beyond glycemic control, is a complex chronic disease that requires continuous medical care with multifactorial risk reduction strategies. It is necessary to reduce the likelihood of complications and additional problems that may develop in the long term. For this reason, guiding the patient to manage the disease process, equipping and supporting the patient with the necessary information is critical to prevent acute problems.
Exercise is the primary treatment method for diabetes patients. Exercise; It is the main treatment method used to increase aerobic capacity and improve respiratory capacity due to the positive effect it has on the body's structure and systems.
Read the detailed description
Firstly, patients were examined by the specialist doctor. If patients appropriate for this study according to inclusion and exclusion criteria, they were consulted to Cardiologist for stress ECG test and acceptation report to high or moderate-intensity aerobic training.
After baseline testing (including aerobic capacity and lung capacity), appropriate patients were randomized to HIIT or MICT groups involving sixteenth sessions of exercise performed over 6 weeks The HIIT exercise protocol involved 28 minutes of treadmill efforts. The patients performed the interval training for 4 minutes with 80%HRmax and active recovery period maintained for 3 minutes with 60% HRmax on the treadmill. This protocol repeated 4 times in a session. The MICT exercise protocol performed with %60 HRmax for 28 minutes similarly HIIT group. A 10-min warm-up and 10-min cool-down period were included for all groups. All groups reassessed after the 6. weeks (end of the exercise program) and 12. weeks (follow-up period).
Aerobic capacity assessed with an Incremental Shuttle Walk Test (ISWT). Clinicians need to 10 m field, audiotape recorder, chronometer, and two markers. This test consists of 12 levels, every level maintains1 minute and the walking speed is increased after every1 minute intervals. If the patients wanted to stop because of fell breathless or can't reach the end of the 10 m line' last 0.5 m in the time allowed, the test was stopped.Estimated VO2max was calculated a formula as "Estimated VO2max (ml/dk/kg)= 4.19 + (0.025 x ISWT distance)".
The patient's pulmonary functions assessed with a digital spirometer (Pony FX, COSMED Inc., Italy). Spirometer device measures FVC, FEV1, FEV1/FVC and PEF values. During the test, upper extremity was straight and patients sitting straight position on the chair with their vertical feet on the floor. The measurements were performed 3 times and the best score recorded with mean and standard deviation.
The measurements were coded into the analysis program and checked by a second researcher.
Post-hoc power analysis was done using aerobic capacity data, which is the main output of our study. The power of the study was determined as 94%.
Patients who had missing data, patients who did not complete the 6-weeks exercise program and 12. weeks follow-up period were excluded from the analysis. All analyses were performed using the Statistical Package for the Social Sciences (SPSS) version 22. 0 for Windows. Data are expressed as mean ± standard deviation. The one-sample Kolmogorov-Smirnov test was performed to assess the distribution of data. Due to their distribution, numerical variables in different subjects were compared with the t-test or Mann-Whitney U test. Comparison of variables before and after the exercise program were compared by the paired t-test (parametric variable) or Wilcoxon test (non-parametric variable). Probability values were two-tailed, and a p-value of less than 0.05 was considered as significant.
- Conditions
- Type-2 Diabetes
- Being tested
- Aerobic Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseProcedure or surgery
Exercise loading is determined by increasing the heart rate. This loading calculated by Karvonen formulas (maximum %80 of Heart Rate)
| Study group | Role | What they receive |
|---|---|---|
| The HIIT Group (High Intensity Interval Training Group) | Experimental | Not described Receives: Procedure: Aerobic Exercise |
| The MICT Group (Moderate Intensity Continous Training Group) | Experimental | Not described Receives: Procedure: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Shuttle Walk Test-ISWT
Aerobic Capacity
Measured: Baseline Assessment
Incremental Shuttle Walk Test-ISWT
Aerobic Capacity
Measured: End of the exercise period assessment (end of the 6. weeks)
Incremental Shuttle Walk Test-ISWT
Aerobic Capacity
Measured: End of the follow-up period assessment (end of the 12. weeks)
Digital Spirometer
FVC parameters were evaluated automatically.
Measured: Baseline Assessment
Digital Spirometer
FVC parameters were evaluated automatically.
Measured: End of the follow-up period assessment (end of the 6. weeks)
Digital Spirometer
FVC parameters were evaluated automatically.
Measured: End of the follow-up period assessment (end of the 12. weeks)
Digital Spirometer
FEV1 were evaluated automatically.
Measured: Baseline Assessment
Digital Spirometer
FEV1 were evaluated automatically.
Measured: End of the follow-up period assessment (end of the 6. weeks)
Digital Spirometer
FEV1 were evaluated automatically.
Measured: End of the follow-up period assessment (end of the 12. weeks)
Digital Spirometer
FEV1/FVC were evaluated automatically.
Measured: Baseline Assessment
Digital Spirometer
FEV1/FVC were evaluated automatically.
Measured: End of the follow-up period assessment (end of the 6. weeks)
Digital Spirometer
FEV1/FVC were evaluated automatically.
Measured: End of the follow-up period assessment (end of the 12. weeks)
Digital Spirometer
PEF parameters were evaluated automatically.
Measured: Baseline Assessment
Digital Spirometer
PEF parameters were evaluated automatically.
Measured: End of the follow-up period assessment (end of the 6. weeks)
Digital Spirometer
PEF parameters were evaluated automatically.
Measured: End of the follow-up period assessment (end of the 12. weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Feb 2019
- Primary completion15 Mar 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type-2 DiabetesStudies of the same condition, open and under way.
- 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
- Model description
- High-Intensity Interval Training Group (HIIT): The HIIT exercise protocol involved 28 minutes of treadmill efforts. The patients performed the interval training for 4 minutes with 80%HRmax and active recovery period maintained for 3 minutes with 60% HRmax on the treadmill with Karvonen formula.This protocol repeated 4 times in a session for 6 weeks. Moderate Intensity Continous Training (MICT): The MICT exercise protocol performed with %60 HRmax for 28 minutes for 6 weeks.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emresenocak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emresenocak, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330911
- Sponsor's protocol ID
- 09.2019.172
- Status last verified
- Apr 2020
- First submitted
- 27 Mar 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Effect of Supervised Exercise Programs on Exercise Capacity and Pulmonary Capacity in Type-2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT04330911
- Acronym / sponsor ID
- 09.2019.172
- Conditions
- Type-2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- EmresenocakUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 2 Apr 2020 (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.
Diabetes, beyond glycemic control, is a complex chronic disease that requires continuous medical care with multifactorial risk reduction strategies. It is necessary to reduce the likelihood of complications and additional problems that may develop in the long term. For this reason, guiding the patient to manage the disease process, equipping and supporting the patient with the necessary information is critical to prevent acute problems.
Exercise is the primary treatment method for diabetes patients. Exercise; It is the main treatment method used to increase aerobic capacity and improve respiratory capacity due to the positive effect it has on the body's structure and systems.
Detailed description
Firstly, patients were examined by the specialist doctor. If patients appropriate for this study according to inclusion and exclusion criteria, they were consulted to Cardiologist for stress ECG test and acceptation report to high or moderate-intensity aerobic training.
After baseline testing (including aerobic capacity and lung capacity), appropriate patients were randomized to HIIT or MICT groups involving sixteenth sessions of exercise performed over 6 weeks The HIIT exercise protocol involved 28 minutes of treadmill efforts. The patients performed the interval training for 4 minutes with 80%HRmax and active recovery period maintained for 3 minutes with 60% HRmax on the treadmill. This protocol repeated 4 times in a session. The MICT exercise protocol performed with %60 HRmax for 28 minutes similarly HIIT group. A 10-min warm-up and 10-min cool-down period were included for all groups. All groups reassessed after the 6. weeks (end of the exercise program) and 12. weeks (follow-up period).
Aerobic capacity assessed with an Incremental Shuttle Walk Test (ISWT). Clinicians need to 10 m field, audiotape recorder, chronometer, and two markers. This test consists of 12 levels, every level maintains1 minute and the walking speed is increased after every1 minute intervals. If the patients wanted to stop because of fell breathless or can't reach the end of the 10 m line' last 0.5 m in the time allowed, the test was stopped.Estimated VO2max was calculated a formula as "Estimated VO2max (ml/dk/kg)= 4.19 + (0.025 x ISWT distance)".
The patient's pulmonary functions assessed with a digital spirometer (Pony FX, COSMED Inc., Italy). Spirometer device measures FVC, FEV1, FEV1/FVC and PEF values. During the test, upper extremity was straight and patients sitting straight position on the chair with their vertical feet on the floor. The measurements were performed 3 times and the best score recorded with mean and standard deviation.
The measurements were coded into the analysis program and checked by a second researcher.
Post-hoc power analysis was done using aerobic capacity data, which is the main output of our study. The power of the study was determined as 94%.
Patients who had missing data, patients who did not complete the 6-weeks exercise program and 12. weeks follow-up period were excluded from the analysis. All analyses were performed using the Statistical Package for the Social Sciences (SPSS) version 22. 0 for Windows. Data are expressed as mean ± standard deviation. The one-sample Kolmogorov-Smirnov test was performed to assess the distribution of data. Due to their distribution, numerical variables in different subjects were compared with the t-test or Mann-Whitney U test. Comparison of variables before and after the exercise program were compared by the paired t-test (parametric variable) or Wilcoxon test (non-parametric variable). Probability values were two-tailed, and a p-value of less than 0.05 was considered as significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- High-Intensity Interval Training Group (HIIT): The HIIT exercise protocol involved 28 minutes of treadmill efforts. The patients performed the interval training for 4 minutes with 80%HRmax and active recovery period maintained for 3 minutes with 60% HRmax on the treadmill with Karvonen formula.This protocol repeated 4 times in a session for 6 weeks. Moderate Intensity Continous Training (MICT): The MICT exercise protocol performed with %60 HRmax for 28 minutes for 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| The HIIT Group (High Intensity Interval Training Group) | Experimental | Procedure: Aerobic Exercise |
| The MICT Group (Moderate Intensity Continous Training Group) | Experimental | Procedure: Aerobic Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with type-2 diabetes mellitus,
- patients who have sedentary lifestyle (<3 bouts of exercise per week and <30 minutes aerobic exercise period),
- non-smoking patients,
- not to lose more than 5% of total body weight in the last 6 months,
- blood pressure<160/100 mmHg
Key exclusion criteria (5 listed)
- alcohol addiction in the last 12 months,
- patients who use insulin hormone,
- patients who have neuropathy or retinopathy,
- patients who have an acute cardiac event in the last 6 weeks,
- patients who have a disease at least 2 weeks in the last 1 month
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 |
|---|---|---|
| Aerobic ExerciseExercise loading is determined by increasing the heart rate. This loading calculated by Karvonen formulas (maximum %80 of Heart Rate) | Procedure or surgery | The HIIT Group (High Intensity Interval Training Group), The MICT Group (Moderate Intensity Continous Training Group) |
Primary outcome
Incremental Shuttle Walk Test-ISWT
Time frame: Baseline Assessment
Aerobic Capacity
Incremental Shuttle Walk Test-ISWT
Time frame: End of the exercise period assessment (end of the 6. weeks)
Aerobic Capacity
Incremental Shuttle Walk Test-ISWT
Time frame: End of the follow-up period assessment (end of the 12. weeks)
Aerobic Capacity
Digital Spirometer
Time frame: Baseline Assessment
FVC parameters were evaluated automatically.
Digital Spirometer
Time frame: End of the follow-up period assessment (end of the 6. weeks)
FVC parameters were evaluated automatically.
Digital Spirometer
Time frame: End of the follow-up period assessment (end of the 12. weeks)
FVC parameters were evaluated automatically.
Digital Spirometer
Time frame: Baseline Assessment
FEV1 were evaluated automatically.
Digital Spirometer
Time frame: End of the follow-up period assessment (end of the 6. weeks)
FEV1 were evaluated automatically.
Digital Spirometer
Time frame: End of the follow-up period assessment (end of the 12. weeks)
FEV1 were evaluated automatically.
Digital Spirometer
Time frame: Baseline Assessment
FEV1/FVC were evaluated automatically.
Digital Spirometer
Time frame: End of the follow-up period assessment (end of the 6. weeks)
FEV1/FVC were evaluated automatically.
Digital Spirometer
Time frame: End of the follow-up period assessment (end of the 12. weeks)
FEV1/FVC were evaluated automatically.
Digital Spirometer
Time frame: Baseline Assessment
PEF parameters were evaluated automatically.
Digital Spirometer
Time frame: End of the follow-up period assessment (end of the 6. weeks)
PEF parameters were evaluated automatically.
Digital Spirometer
Time frame: End of the follow-up period assessment (end of the 12. weeks)
PEF parameters were evaluated automatically.
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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Type-2 Diabetes, run by Emresenocak 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 5 inclusion and 5 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?
Incremental Shuttle Walk Test-ISWT (time frame: Baseline Assessment). The study lists 15 primary outcomes in all. 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.