Metabolic DiseasesNCT02715063
Cardiometabolic HIIT-RT Study
A study testing High Intensity Interval, Resistance training and Plus: High Intensity Interval + Resistance Training in people with Metabolic Diseases and Overweight, run by Universidad Santo Tomas at 1 site in Colombia.
Trial summary
Several studies have shown relationship between exercise intensity and improvement cardiometabolic health such as body composition, endothelial function, blood pressure and blood lipids. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases, Overweight, Motor Activity
- What is being tested?
- High Intensity Interval, Resistance training and Plus: High Intensity Interval + Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2016to Jan 2017
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meets at least one criteria for metabolic Syndrome (IDF 2006): Central obesity: waist circumference ≥90cm (men) ≥80cm (women); triglycerides ≥ 150mg/dl; HDL-c <40mg/dl (men) <50 (women); Blood pressure ≥130/85mmHg and fasting plasma glucose ≥ 100mg/dL.
- 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 Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): Study Protocol for a Factorial Randomised Controlled Trial
Several studies have shown relationship between exercise intensity and improvement cardiometabolic health such as body composition, endothelial function, blood pressure and blood lipids. It has been suggested that high intensity interval training and also strength or resistance training generate positive effects on metabolic risk factors, nevertheless the comparison between both types of training and their combination has not yet provided conclusive evidence. Also, it has been shown that dietary restriction has similar or more positive effects that exercise alone and the effect is greater when it is combined with exercise. For these reasons, it is necessary to clarify which type of training, in combination with a dietary restriction, is more effective to improve cardiometabolic health
Read the detailed description
The investigators hypothesized that high intensity interval, resistance training or combined training would result in similar improvements in cardiometabolic health as compared to the usual clinical care in a cohort of sedentary overweight (age 30-50 years old).
- Conditions
- Metabolic Diseases, Overweight, Motor Activity
- Being tested
- High Intensity Interval, Resistance training, Plus: High Intensity Interval + Resistance Training, Usual clinical care
- Medical subject headings
- Metabolic Diseases, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity IntervalBehavioural
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Resistance trainingBehavioural
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Plus: High Intensity Interval + Resistance TrainingBehavioural
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Usual clinical careOther
Dietary restriction (1300-1500kcal) 50-52% carbohydrates, 33-35% fat, 15-20% protein
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval | 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 during adaptation (first 4 weeks) and 500 kcal after week number 4 until the end of training. Receives: Behavioral: High Intensity Interval |
| Resistance training | Active comparator | Completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 300 kcal during adaptation (first 4 weeks) at 20-30% of 1 one-rep max and 500 kcal after week number 4 until the end of training, at 40-60% of one-rep max. Receives: Behavioral: Resistance training |
| Plus: High Intensity Interval + Resistance Training | Active comparator | Walking on a treadmill as intervention 1 until 50% the energy expenditure prescribed is reached, then completing a resistance circuit until 100% energy expenditure is reached. Exercise will be performed at three sessions per week. Receives: Behavioral: Plus: High Intensity Interval + Resistance Training |
| Usual clinical care | Placebo comparator | This group will receive the usual clinical care according to the consensus recommendations of the national goals for cardiovascular health promotion and disease reduction of the American Heart Association and Colombian guidelines COLDEPORTES. Receives: Other: Usual clinical care |
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 and 12 weeks immediately after the interventions ends
Secondary outcomes (16)
Change from Baseline in body Composition as measured by Dual Energy X-ray Absorptiometry
Changes in abdominal and total adiposity (DEXA), lean tissue mass and bone mass (DEXA) the 12 weeks intervention program
Measured: Baseline and 12 weeks immediately after the interventions ends
Body Weight
Measured: Baseline and 12 weeks immediately after the interventions ends
Body Mass Index
BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
Measured: Baseline and 12 weeks immediately after the interventions ends
Blood Pressure
Measured: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in peak uptake of volume of oxygen
It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol
Measured: Baseline and 12 weeks immediately after the interventions ends
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 and 12 weeks immediately after the interventions ends
Change from Baseline in Flexibility using the sit and reach test
Measured: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in LDL Cholesterol
Measured: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in HDL Cholesterol
Measured: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in Triglycerides
Measured: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in Glucose
Measured: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in Hemoglobin A1c
Measured: Baseline and 12 weeks immediately after the interventions ends
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
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 and 12 weeks immediately after the interventions ends
24-hour dietary recall
Dietary data will be collected from participants on 24h of their study enrollment. Prior to administration of the 24HR, each subject received two-dimensional food models with depiction of foods and serving sizes in order to assist in reporting portion sizes of food intake.
Measured: Baseline and 12 weeks immediately after the interventions ends
Aortic pulse wave velocity (PWVao) and augmentation index (AIx)
PWVao and AIx will be measured with oscillometric method using the occlusion technique.
Measured: Baseline and 12 weeks immediately after the interventions ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Santo Tomas
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad del Rosario, Universidad Manuela Beltrán
- Responsible party
- Sponsor
- Investigators
- Robinson Ramírez Vélez, Ph.D, Principal investigator, Universidad del Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715063
- Sponsor's protocol ID
- 06-1006-2014
- Status last verified
- Oct 2018
- First submitted
- 8 Mar 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ramirez-Velez R, Correa-Bautista JE, Gonzalez-Ruiz K, Tordecilla-Sanders A, Garcia-Hermoso A, Schmidt-RioValle J, Gonzalez-Jimenez E. The Role of Body Adiposity Index in Determining Body Fat Percentage in Colombian Adults with Overweight or Obesity. Int J Environ Res Public Health. 2017 Sep 21;14(10):1093. doi: 10.3390/ijerph14101093.
PubMed 28934175Ramirez-Velez R, Hernandez A, Castro K, Tordecilla-Sanders A, Gonzalez-Ruiz K, Correa-Bautista JE, Izquierdo M, Garcia-Hermoso A. High Intensity Interval- vs Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): study protocol for a randomised controlled trial. Trials. 2016 Jun 24;17(1):298. doi: 10.1186/s13063-016-1422-1.
PubMed 27342073
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval- vs Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): Study Protocol for a Factorial Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02715063
- Acronym / sponsor ID
- 06-1006-2014
- Conditions
- Metabolic Diseases, Overweight, Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Santo TomasUniversity, hospital or other
- Collaborators
- Universidad del Rosario, Universidad Manuela Beltrán
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 22 Mar 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 such as body composition, endothelial function, blood pressure and blood lipids. It has been suggested that high intensity interval training and also strength or resistance training generate positive effects on metabolic risk factors, nevertheless the comparison between both types of training and their combination has not yet provided conclusive evidence. Also, it has been shown that dietary restriction has similar or more positive effects that exercise alone and the effect is greater when it is combined with exercise. For these reasons, it is necessary to clarify which type of training, in combination with a dietary restriction, is more effective to improve cardiometabolic health
Detailed description
The investigators hypothesized that high intensity interval, resistance training or combined training would result in similar improvements in cardiometabolic health as compared to the usual clinical care in a cohort of sedentary overweight (age 30-50 years old).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval | Experimental | Behavioral: High Intensity IntervalWalking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 300 kcal during adaptation (first 4 weeks) and 500 kcal after week number 4 until the end of training. |
| Resistance training | Active comparator | Behavioral: Resistance trainingCompleting a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 300 kcal during adaptation (first 4 weeks) at 20-30% of 1 one-rep max and 500 kcal after week number 4 until the end of training, at 40-60% of one-rep max. |
| Plus: High Intensity Interval + Resistance Training | Active comparator | Behavioral: Plus: High Intensity Interval + Resistance TrainingWalking on a treadmill as intervention 1 until 50% the energy expenditure prescribed is reached, then completing a resistance circuit until 100% energy expenditure is reached. Exercise will be performed at three sessions per week. |
| Usual clinical care | Placebo comparator | Other: Usual clinical careThis group will receive the usual clinical care according to the consensus recommendations of the national goals for cardiovascular health promotion and disease reduction of the American Heart Association and Colombian guidelines COLDEPORTES. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meets at least one criteria for metabolic Syndrome (IDF 2006): Central obesity: waist circumference ≥90cm (men) ≥80cm (women); triglycerides ≥ 150mg/dl; HDL-c <40mg/dl (men) <50 (women); Blood pressure ≥130/85mmHg and fasting plasma glucose ≥ 100mg/dL.
- 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 IntervalExercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional. | Behavioural | High Intensity Interval |
| Resistance trainingExercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional. | Behavioural | Resistance training |
| Plus: High Intensity Interval + Resistance TrainingExercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional. | Behavioural | Plus: High Intensity Interval + Resistance Training |
| Usual clinical careDietary restriction (1300-1500kcal) 50-52% carbohydrates, 33-35% fat, 15-20% protein | Other | Usual clinical care |
Primary outcome
Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
Time frame: Baseline and 12 weeks immediately after the interventions ends
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.
16 secondary outcomes
Change from Baseline in body Composition as measured by Dual Energy X-ray Absorptiometry
Time frame: Baseline and 12 weeks immediately after the interventions ends
Body Weight
Time frame: Baseline and 12 weeks immediately after the interventions ends
Body Mass Index
Time frame: Baseline and 12 weeks immediately after the interventions ends
Blood Pressure
Time frame: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in peak uptake of volume of oxygen
Time frame: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in muscular fitness
Time frame: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in Flexibility using the sit and reach test
Time frame: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in LDL Cholesterol
Time frame: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in HDL Cholesterol
Time frame: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in Triglycerides
Time frame: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in Glucose
Time frame: Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in Hemoglobin A1c
Time frame: Baseline and 12 weeks immediately after the interventions ends
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
Change from Baseline in Heart rate variability
Time frame: Baseline and 12 weeks immediately after the interventions ends
24-hour dietary recall
Time frame: Baseline and 12 weeks immediately after the interventions ends
Aortic pulse wave velocity (PWVao) and augmentation index (AIx)
Time frame: Baseline and 12 weeks immediately after the interventions ends
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 11 Oct 2018.
- Derived from this study: PubMed 28934175Ramirez-Velez R, Correa-Bautista JE, Gonzalez-Ruiz K, Tordecilla-Sanders A, Garcia-Hermoso A, Schmidt-RioValle J, Gonzalez-Jimenez E. The Role of Body Adiposity Index in Determining Body Fat Percentage in Colombian Adults with Overweight or Obesity. Int J Environ Res Public Health. 2017 Sep 21;14(10):1093. doi: 10.3390/ijerph14101093.
- Derived from this study: PubMed 27342073Ramirez-Velez R, Hernandez A, Castro K, Tordecilla-Sanders A, Gonzalez-Ruiz K, Correa-Bautista JE, Izquierdo M, Garcia-Hermoso A. High Intensity Interval- vs Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): study protocol for a randomised controlled trial. Trials. 2016 Jun 24;17(1):298. doi: 10.1186/s13063-016-1422-1.
- 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 principal investigator
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, Resistance training and Plus: High Intensity Interval + Resistance Training in people with Metabolic Diseases and Overweight, 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 3 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 11 Oct 2018. 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. Some participants in this study may receive a placebo. 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 and 12 weeks immediately after the interventions ends). 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 NCT02715063, which also lists 2 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 11 Oct 2018.