Metabolic DiseasesHIIT-HeartNCT02738385
Intensity Training and Cardiovascular Health in Colombian Adults
A study testing High Intensity Interval Training and Moderate Intensity Interval Training in people with Metabolic Diseases, run by Universidad Santo Tomas at 1 site in Colombia.
Trial summary
Several studies have shown relationship between exercise intensity and improvement cardiometabolic health. It has been suggested that high intensity interval training and also moderate training generate positive effects on metabolic risk factors. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases
- What is being tested?
- High Intensity Interval Training and Moderate Intensity Interval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteColombia
- Study dates
- Jun 2015to Oct 2016
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent.
- Interested in improving health and fitness.
Who cannot join
- Systemic infections.
- Weight loss or gain of >10% of body weight in the past 6 months for any reason.
- Currently taking medication that suppresses or stimulates appetite.
- Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
- Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
- Asthma.
Show all 12Show fewer
- Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications.
- Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months).
- Any active use of illegal or illicit drugs.
- Current exerciser (>30 min organized exercise per week).
- Indication of unsuitability of current health for exercise protocol (PARQ).
- Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Intensity Interval- vs Moderate Training on Biomarkers of Endothelial and Cardiovascular Health in Adults: Effect of Postprandial Period
Several studies have shown relationship between exercise intensity and improvement cardiometabolic health. It has been suggested that high intensity interval training and also moderate training generate positive effects on metabolic risk factors. For these reasons, it is necessary to clarify which type of training, is more effective to improve cardiometabolic health in latinamerican population.
- Conditions
- Metabolic Diseases
- Being tested
- High Intensity Interval Training, Moderate Intensity Interval Training
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingBehavioural
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Moderate Intensity Interval TrainingBehavioural
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Experimental | Walking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 300 kcal until the end of training. Receives: Behavioral: High Intensity Interval Training |
| Moderate Intensity Interval Training | Active comparator | Walking on a treadmill at 60-80% peak heart rate until expenditure of 300 kcal until the end of training. Receives: Behavioral: Moderate Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
FMD will be measured using the guidelines reported by Corretti et al. The diameter of the brachial artery will be assessed using a high-resolution ultrasound device (Siemens SG-60, USA), equipped with a 7.5 MHz linear array transducer
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Secondary outcomes (14)
Change from Baseline in LDL Cholesterol
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in HDL Cholesterol
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Triglycerides
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Glucose
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Heart rate variability
HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Aortic pulse wave velocity (PWVao)
PWVao (m s-1) will be performed within 3 to 4 minutes with the oscillometric, occlusive device, the Arteriograph. The measurement will be taken in a supine position and were accepted if the quality indicator of the recordings was within the acceptable range (i.e., if the standard deviation [SD] of the beat-to-beat measured PWVao values was less than 1.1 m/sec).
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in muscular fitness
Muscular fitness (MF) will be assessed using handgrip test (maximum handgrip strength assessment) using a standard adjustable handle analogue handgrip dynamometer T-18 TKK SMEDLY III®
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Flexibility using the sit and reach test
It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in peak uptake of volume of oxygen
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Blood Pressure
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Body Mass Index
BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Body Mass
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version
Measured: Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Augmentation index (AIx)
AIx (%) will be performed within 3 to 4 minutes with the oscillometric, occlusive device, the Arteriograph. The measurement will be taken in a supine position and were accepted if the quality indicator of the recordings was within the acceptable range (i.e., if the standard deviation [SD] of the beat-to-beat measured AIx values was less than 1.1 m/sec).
Measured: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startJun 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Santo Tomas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robinson Ramírez-Vélez, Universidad Santo Tomas
- Investigators
- Robinson Ramírez Vélez, Ph.D, Study director, Universidad del Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738385
- Sponsor's protocol ID
- 01-1802-2013
- Acronym
- HIIT-Heart
- Status last verified
- Oct 2016
- First submitted
- 23 Mar 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ramirez-Velez R, Hernandez-Quinones PA, Tordecilla-Sanders A, Alvarez C, Ramirez-Campillo R, Izquierdo M, Correa-Bautista JE, Garcia-Hermoso A, Garcia RG. Effectiveness of HIIT compared to moderate continuous training in improving vascular parameters in inactive adults. Lipids Health Dis. 2019 Feb 4;18(1):42. doi: 10.1186/s12944-019-0981-z.
PubMed 30717757Ramirez-Velez R, Correa-Rodriguez M, Tordecilla-Sanders A, Aya-Aldana V, Izquierdo M, Correa-Bautista JE, Alvarez C, Garcia-Hermoso A. Exercise and postprandial lipemia: effects on vascular health in inactive adults. Lipids Health Dis. 2018 Apr 3;17(1):69. doi: 10.1186/s12944-018-0719-3.
PubMed 29615070Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Similar cardiometabolic effects of high- and moderate-intensity training among apparently healthy inactive adults: a randomized clinical trial. J Transl Med. 2017 May 30;15(1):118. doi: 10.1186/s12967-017-1216-6.
PubMed 28558739Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Effect of Moderate- Versus High-Intensity Interval Exercise Training on Heart Rate Variability Parameters in Inactive Latin-American Adults: A Randomized Clinical Trial. J Strength Cond Res. 2020 Dec;34(12):3403-3415. doi: 10.1519/JSC.0000000000001833.
PubMed 28198783
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval- vs Moderate Training on Biomarkers of Endothelial and Cardiovascular Health in Adults: Effect of Postprandial Period
- ClinicalTrials.gov ID
- NCT02738385
- Acronym / sponsor ID
- HIIT-Heart / 01-1802-2013
- Conditions
- Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Santo TomasUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Apr 2016 (estimated)
- 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.
Several studies have shown relationship between exercise intensity and improvement cardiometabolic health. It has been suggested that high intensity interval training and also moderate training generate positive effects on metabolic risk factors. For these reasons, it is necessary to clarify which type of training, is more effective to improve cardiometabolic health in latinamerican population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Experimental | Behavioral: High Intensity Interval TrainingWalking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 300 kcal until the end of training. |
| Moderate Intensity Interval Training | Active comparator | Behavioral: Moderate Intensity Interval TrainingWalking on a treadmill at 60-80% peak heart rate until expenditure of 300 kcal until the end of training. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Written informed consent.
- Interested in improving health and fitness.
Key exclusion criteria (12 listed)
- Systemic infections.
- Weight loss or gain of >10% of body weight in the past 6 months for any reason.
- Currently taking medication that suppresses or stimulates appetite.
- Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
- Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
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 |
|---|---|---|
| High Intensity Interval TrainingExercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional. | Behavioural | High Intensity Interval Training |
| Moderate Intensity Interval TrainingExercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional. | Behavioural | Moderate Intensity Interval Training |
Primary outcome
Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
FMD will be measured using the guidelines reported by Corretti et al. The diameter of the brachial artery will be assessed using a high-resolution ultrasound device (Siemens SG-60, USA), equipped with a 7.5 MHz linear array transducer
14 secondary outcomes
Change from Baseline in LDL Cholesterol
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in HDL Cholesterol
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Triglycerides
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Glucose
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Heart rate variability
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Aortic pulse wave velocity (PWVao)
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in muscular fitness
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Flexibility using the sit and reach test
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in peak uptake of volume of oxygen
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Blood Pressure
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Body Mass Index
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Body Mass
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version
Time frame: Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Augmentation index (AIx)
Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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 25 Oct 2016.
- Derived from this study: PubMed 30717757Ramirez-Velez R, Hernandez-Quinones PA, Tordecilla-Sanders A, Alvarez C, Ramirez-Campillo R, Izquierdo M, Correa-Bautista JE, Garcia-Hermoso A, Garcia RG. Effectiveness of HIIT compared to moderate continuous training in improving vascular parameters in inactive adults. Lipids Health Dis. 2019 Feb 4;18(1):42. doi: 10.1186/s12944-019-0981-z.
- Derived from this study: PubMed 29615070Ramirez-Velez R, Correa-Rodriguez M, Tordecilla-Sanders A, Aya-Aldana V, Izquierdo M, Correa-Bautista JE, Alvarez C, Garcia-Hermoso A. Exercise and postprandial lipemia: effects on vascular health in inactive adults. Lipids Health Dis. 2018 Apr 3;17(1):69. doi: 10.1186/s12944-018-0719-3.
- Derived from this study: PubMed 28558739Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Similar cardiometabolic effects of high- and moderate-intensity training among apparently healthy inactive adults: a randomized clinical trial. J Transl Med. 2017 May 30;15(1):118. doi: 10.1186/s12967-017-1216-6.
- Derived from this study: PubMed 28198783Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Effect of Moderate- Versus High-Intensity Interval Exercise Training on Heart Rate Variability Parameters in Inactive Latin-American Adults: A Randomized Clinical Trial. J Strength Cond Res. 2020 Dec;34(12):3403-3415. doi: 10.1519/JSC.0000000000001833.
- 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.
Robinson Ramírez Vélez, Ph.D study director
Universidad del Rosario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training and Moderate Intensity Interval Training in people with Metabolic Diseases, run by Universidad Santo Tomas at 1 site in Colombia.
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 2 inclusion and 12 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 25 Oct 2016. 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 Colombia. 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?
Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD) (time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02738385, which also lists 4 linked publications.
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 25 Oct 2016.