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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

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

Condition or disease Intervention/treatment Phase
Metabolic Diseases Overweight Motor Activity Behavioral: High Intensity Interval Behavioral: Resistance training Behavioral: Plus: High Intensity Interval + Resistance Training Other: Usual clinical care Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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 Start Date : January 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Arm Intervention/treatment
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.
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.

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.
Behavioral: Resistance training
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.

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.
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.

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.
Other: Usual clinical care
Dietary restriction (1300-1500kcal) 50-52% carbohydrates, 33-35% fat, 15-20% protein




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Body Weight [ Time Frame: Baseline and 12 weeks immediately after the interventions ends ]
  3. 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.

  4. Blood Pressure [ Time Frame: Baseline and 12 weeks immediately after the interventions ends ]
  5. 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

  6. 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®

  7. Change from Baseline in Flexibility using the sit and reach test [ Time Frame: Baseline and 12 weeks immediately after the interventions ends ]
  8. Change from Baseline in LDL Cholesterol [ Time Frame: Baseline and 12 weeks immediately after the interventions ends ]
  9. Change from Baseline in HDL Cholesterol [ Time Frame: Baseline and 12 weeks immediately after the interventions ends ]
  10. Change from Baseline in Triglycerides [ Time Frame: Baseline and 12 weeks immediately after the interventions ends ]
  11. Change from Baseline in Glucose [ Time Frame: Baseline and 12 weeks immediately after the interventions ends ]
  12. Change from Baseline in Hemoglobin A1c [ Time Frame: Baseline and 12 weeks immediately after the interventions ends ]
  13. 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 ]
  14. 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

  15. 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.

  16. 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.



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715063


Locations
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Colombia
Robinson Ramírez Vélez Ph.D
Bogotá, Cundinamarca, Colombia
Sponsors and Collaborators
Universidad Santo Tomas
Universidad del Rosario
Universidad Manuela Beltrán
Investigators
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Principal Investigator: Robinson Ramírez Vélez, Ph.D Universidad del Rosario
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidad Santo Tomas
ClinicalTrials.gov Identifier: NCT02715063    
Other Study ID Numbers: 06-1006-2014
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Metabolic Diseases
Overweight
Body Weight