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Intensity Training and Cardiovascular Health in Colombian Adults (HIIT-Heart)

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ClinicalTrials.gov Identifier: NCT02738385
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Robinson Ramírez-Vélez, Universidad Santo Tomas

Brief Summary:
Several studies have shown relationship between exercise intensity and improvement cardiometabolic health. It has been suggested that high intensity interval training and also moderate training generate positive effects on metabolic risk factors. For these reasons, it is necessary to clarify which type of training, is more effective to improve cardiometabolic health in latinamerican population.

Condition or disease Intervention/treatment Phase
Metabolic Diseases Behavioral: High Intensity Interval Training Behavioral: Moderate Intensity Interval Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: High Intensity Interval- vs Moderate Training on Biomarkers of Endothelial and Cardiovascular Health in Adults: Effect of Postprandial Period
Study Start Date : June 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Intensity Interval Training
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 until the end of training.
Behavioral: High Intensity Interval Training
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.

Active Comparator: Moderate Intensity Interval Training
Walking on a treadmill at 60-80% peak heart rate until expenditure of 300 kcal until the end of training.
Behavioral: Moderate Intensity Interval Training
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.




Primary Outcome Measures :
  1. Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD) [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
    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 LDL Cholesterol [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
  2. Change from Baseline in HDL Cholesterol [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
  3. Change from Baseline in Triglycerides [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
  4. Change from Baseline in Glucose [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
  5. Change from Baseline in Heart rate variability [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
    HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware

  6. Aortic pulse wave velocity (PWVao) [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
    PWVao (m s−1) will be performed within 3 to 4 minutes with the oscillometric, occlusive device, the Arteriograph. The measurement will be taken in a supine position and were accepted if the quality indicator of the recordings was within the acceptable range (i.e., if the standard deviation [SD] of the beat-to-beat measured PWVao values was less than 1.1 m/sec).

  7. Change from Baseline in muscular fitness [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
    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®

  8. Change from Baseline in Flexibility using the sit and reach test [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
    It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol

  9. Change from Baseline in peak uptake of volume of oxygen [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
  10. Change from Baseline in Blood Pressure [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
  11. Change from Baseline in Body Mass Index [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
    BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.

  12. Change from Baseline in Body Mass [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
  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, preceding an 'unhealthy' meal. ]
  14. Augmentation index (AIx) [ Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. ]
    AIx (%) will be performed within 3 to 4 minutes with the oscillometric, occlusive device, the Arteriograph. The measurement will be taken in a supine position and were accepted if the quality indicator of the recordings was within the acceptable range (i.e., if the standard deviation [SD] of the beat-to-beat measured AIx values was less than 1.1 m/sec).



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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): NCT02738385


Locations
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Colombia
Robinson Ramírez Vélez Ph.D
Bogotá, Colombia
Sponsors and Collaborators
Universidad Santo Tomas
Investigators
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Study Director: 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: Robinson Ramírez-Vélez, Principal Professor. Center of Studies in Physical Activity Measurements, School of Medicine and Health Sciences, Universidad Santo Tomas
ClinicalTrials.gov Identifier: NCT02738385     History of Changes
Other Study ID Numbers: 01-1802-2013
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Metabolic Diseases