Clinical trial NCT02715063: Cardiometabolic HIIT-RT 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Diseases
Overweight
Motor Activity
Lead sponsor: Universidad Santo Tomas
Sponsor class: OTHER
Collaborators: name: Universidad del Rosario
name: Universidad Manuela Beltrán
First posted: 2016-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
timeFrame: Baseline and 12 weeks immediately after the interventions ends
Secondary outcomes:
measure: Change from Baseline in body Composition as measured by Dual Energy X-ray Absorptiometry
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Body Weight
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Body Mass Index
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Blood Pressure
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Change from Baseline in peak uptake of volume of oxygen
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Change from Baseline in muscular fitness
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Change from Baseline in Flexibility using the sit and reach test
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Change from Baseline in LDL Cholesterol
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Change from Baseline in HDL Cholesterol
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Change from Baseline in Triglycerides
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Change from Baseline in Glucose
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Change from Baseline in Hemoglobin A1c
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Change from Baseline in Heart rate variability
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: 24-hour dietary recall
timeFrame: Baseline and 12 weeks immediately after the interventions ends
measure: Aortic pulse wave velocity (PWVao) and augmentation index (AIx)
timeFrame: Baseline and 12 weeks immediately after the interventions ends
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Robinson Ramírez Vélez Ph.D
state: Cundinamarca
Study officials:
affiliation: Universidad del Rosario
name: Robinson Ramírez Vélez, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ramirez-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.