Intensity Training and Cardiovascular Health in Colombian Adults

Not Applicable

Completed

• Conditions: Metabolic Diseases
• Interventions: Behavioral: High Intensity Interval Training; Behavioral: Moderate Intensity Interval Training

• Registration Number: NCT02738385
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-14
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Intensity Interval Training	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.
Moderate Intensity Interval Training	Moderate Intensity Interval Training	Walking on a treadmill at 60-80% peak heart rate until expenditure of 300 kcal until the end of training.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)	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

Name	Time	Method
Change from Baseline in Triglycerides	Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in muscular fitness	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®
Change from Baseline in LDL Cholesterol	Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in peak uptake of volume of oxygen	Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Blood Pressure	Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Body Mass	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	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
Augmentation index (AIx)	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).
Change from Baseline in HDL Cholesterol	Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Glucose	Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Heart rate variability	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
Change from Baseline in Body Mass Index	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.
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.
Aortic pulse wave velocity (PWVao)	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).

Trial Locations

Locations (1)

Robinson Ramírez Vélez Ph.D; 🇨🇴 Bogotá, Colombia