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Cardiometabolic HIIT-RT Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715063
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Universidad del Rosario
Universidad Manuela Beltrán
Information provided by (Responsible Party):
Universidad Santo Tomas

Tracking Information
First Submitted Date  ICMJE March 8, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date October 11, 2018
Study Start Date  ICMJE January 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • 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 ]
    Changes in abdominal and total adiposity (DEXA), lean tissue mass and bone mass (DEXA) the 12 weeks intervention program
  • 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 ]
    BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
  • 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 ]
    It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol
  • Change from Baseline in muscular fitness [ Time Frame: Baseline and 12 weeks immediately after the interventions ends ]
    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®
  • 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 ]
    HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware
  • 24-hour dietary recall [ Time Frame: Baseline and 12 weeks immediately after the interventions ends ]
    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.
  • Aortic pulse wave velocity (PWVao) and augmentation index (AIx) [ Time Frame: Baseline and 12 weeks immediately after the interventions ends ]
    PWVao and AIx will be measured with oscillometric method using the occlusion technique.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiometabolic HIIT-RT Study
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Metabolic Diseases
  • Overweight
  • Motor Activity
Intervention  ICMJE
  • Behavioral: High Intensity Interval
    Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
  • Behavioral: Resistance training
    Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
  • Behavioral: Plus: High Intensity Interval + Resistance Training
    Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
  • Other: Usual clinical care
    Dietary restriction (1300-1500kcal) 50-52% carbohydrates, 33-35% fat, 15-20% protein
Study Arms  ICMJE
  • Experimental: High Intensity Interval
    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.
    Intervention: Behavioral: High Intensity Interval
  • Active Comparator: Resistance training
    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.
    Intervention: Behavioral: Resistance training
  • Active Comparator: Plus: High Intensity Interval + Resistance Training
    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.
    Intervention: Behavioral: Plus: High Intensity Interval + Resistance Training
  • Placebo Comparator: Usual clinical care
    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.
    Intervention: Other: Usual clinical care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02715063
Other Study ID Numbers  ICMJE 06-1006-2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universidad Santo Tomas
Study Sponsor  ICMJE Universidad Santo Tomas
Collaborators  ICMJE
  • Universidad del Rosario
  • Universidad Manuela Beltrán
Investigators  ICMJE
Principal Investigator: Robinson Ramírez Vélez, Ph.D Universidad del Rosario
PRS Account Universidad Santo Tomas
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP