Cardiometabolic HIIT-RT Study
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
1 other identifier
interventional
60
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 8, 2016
CompletedFirst Posted
Study publicly available on registry
March 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedOctober 11, 2018
October 1, 2018
11 months
March 8, 2016
October 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
Baseline and 12 weeks immediately after the interventions ends
Body Weight
Baseline and 12 weeks immediately after the interventions ends
Body Mass Index
Baseline and 12 weeks immediately after the interventions ends
Blood Pressure
Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in peak uptake of volume of oxygen
Baseline and 12 weeks immediately after the interventions ends
- +11 more secondary outcomes
Study Arms (4)
High Intensity Interval
EXPERIMENTALWalking 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 COMPARATORCompleting 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 COMPARATORWalking 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 COMPARATORThis 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.
Interventions
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Dietary restriction (1300-1500kcal) 50-52% carbohydrates, 33-35% fat, 15-20% protein
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Santo Tomaslead
- Universidad del Rosariocollaborator
- Universidad Manuela Beltráncollaborator
Study Sites (1)
Robinson Ramírez Vélez Ph.D
Bogotá, Cundinamarca, Colombia
Related Publications (2)
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.
PMID: 28934175DERIVEDRamirez-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.
PMID: 27342073DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robinson Ramírez Vélez, Ph.D
Universidad del Rosario
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2016
First Posted
March 22, 2016
Study Start
January 1, 2016
Primary Completion
December 1, 2016
Study Completion
January 1, 2017
Last Updated
October 11, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share