Intensity Training and Cardiovascular Health in Colombian Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2016
• Main ID: NCT02738385
• Date of registration: 23/03/2016
• Prospective Registration: No
• Primary sponsor: Universidad Santo Tomas
• Public title: Intensity Training and Cardiovascular Health in Colombian Adults HIIT-Heart
• Scientific title: High Intensity Interval- vs Moderate Training on Biomarkers of Endothelial and Cardiovascular Health in Adults: Effect of Postprandial Period
• Date of first enrolment: June 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02738385
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Colombia

Contacts

• Name: Robinson Ramírez Vélez, Ph.D
• Affiliation: Universidad del Rosario

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Metabolic Diseases

Intervention(s)

Behavioral: Moderate Intensity Interval Training

Behavioral: High Intensity Interval Training

Primary Outcome(s)

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.]

Secondary Outcome(s)

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

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

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.]

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

Aortic pulse wave velocity (PWVao) [Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.]

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

Change from Baseline in Body Mass Index [Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.]

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

Augmentation index (AIx) [Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.]

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.]

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

Change from Baseline in Heart rate variability [Time Frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.]

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

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.]

Secondary ID(s)

01-1802-2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors