Intensity Training and Cardiovascular Health in Colombian Adults

Metabolic Diseases Clinical Trial

— HIIT-Heart  

Official title:

High Intensity Interval- vs Moderate Training on Biomarkers of Endothelial and Cardiovascular Health in Adults: Effect of Postprandial Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738385
• Other study ID #: 01-1802-2013
• Status: Completed
• Phase: N/A
• First received: March 23, 2016
• Last updated: October 24, 2016
• Start date: June 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Universidad Santo Tomas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Colombia	Robinson Ramírez Vélez Ph.D	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Santo Tomas

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)	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	Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Change from Baseline in LDL Cholesterol		Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Change from Baseline in HDL Cholesterol		Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Change from Baseline in Triglycerides		Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Change from Baseline in Glucose		Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Change from Baseline in Heart rate variability	HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware	Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Aortic pulse wave velocity (PWVao)	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).	Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Change from Baseline in muscular fitness	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®	Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Change from Baseline in Flexibility using the sit and reach test	It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol	Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Change from Baseline in peak uptake of volume of oxygen		Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Change from Baseline in Blood Pressure		Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Change from Baseline in Body Mass Index	BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.	Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Change from Baseline in Body Mass		Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version		Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No
Secondary	Augmentation index (AIx)	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).	Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.	No