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

Primary Purpose

Metabolic Diseases

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
High Intensity Interval Training
Moderate Intensity Interval Training
Sponsored by
Universidad Santo Tomas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Diseases

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Robinson Ramírez Vélez Ph.D

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity Interval Training

Moderate Intensity Interval Training

Arm Description

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.

Walking on a treadmill at 60-80% peak heart rate until expenditure of 300 kcal until the end of training.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline in LDL Cholesterol
Change from Baseline in HDL Cholesterol
Change from Baseline in Triglycerides
Change from Baseline in Glucose
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
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).
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®
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
Change from Baseline in peak uptake of volume of oxygen
Change from Baseline in Blood Pressure
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.
Change from Baseline in Body Mass
Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version
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).

Full Information

First Posted
March 23, 2016
Last Updated
October 24, 2016
Sponsor
Universidad Santo Tomas
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1. Study Identification

Unique Protocol Identification Number
NCT02738385
Brief Title
Intensity Training and Cardiovascular Health in Colombian Adults
Acronym
HIIT-Heart
Official Title
High Intensity Interval- vs Moderate Training on Biomarkers of Endothelial and Cardiovascular Health in Adults: Effect of Postprandial Period
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Santo Tomas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Moderate Intensity Interval Training
Arm Type
Active Comparator
Arm Description
Walking on a treadmill at 60-80% peak heart rate until expenditure of 300 kcal until the end of training.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval Training
Intervention Description
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Intervention Type
Behavioral
Intervention Name(s)
Moderate Intensity Interval Training
Intervention Description
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Primary Outcome Measure Information:
Title
Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
Description
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
Time Frame
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Secondary Outcome Measure Information:
Title
Change from Baseline in LDL Cholesterol
Time Frame
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Title
Change from Baseline in HDL Cholesterol
Time Frame
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Title
Change from Baseline in Triglycerides
Time Frame
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Title
Change from Baseline in Glucose
Time Frame
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Title
Change from Baseline in Heart rate variability
Description
HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware
Time Frame
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Title
Aortic pulse wave velocity (PWVao)
Description
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).
Time Frame
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Title
Change from Baseline in muscular fitness
Description
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®
Time Frame
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Title
Change from Baseline in Flexibility using the sit and reach test
Description
It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol
Time Frame
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Title
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.
Title
Change from Baseline in Blood Pressure
Time Frame
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Title
Change from Baseline in Body Mass Index
Description
BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
Time Frame
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Title
Change from Baseline in Body Mass
Time Frame
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Title
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.
Title
Augmentation index (AIx)
Description
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).
Time Frame
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robinson Ramírez Vélez, Ph.D
Organizational Affiliation
Universidad del Rosario
Official's Role
Study Director
Facility Information:
Facility Name
Robinson Ramírez Vélez Ph.D
City
Bogotá
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30717757
Citation
Ramirez-Velez R, Hernandez-Quinones PA, Tordecilla-Sanders A, Alvarez C, Ramirez-Campillo R, Izquierdo M, Correa-Bautista JE, Garcia-Hermoso A, Garcia RG. Effectiveness of HIIT compared to moderate continuous training in improving vascular parameters in inactive adults. Lipids Health Dis. 2019 Feb 4;18(1):42. doi: 10.1186/s12944-019-0981-z.
Results Reference
derived
PubMed Identifier
29615070
Citation
Ramirez-Velez R, Correa-Rodriguez M, Tordecilla-Sanders A, Aya-Aldana V, Izquierdo M, Correa-Bautista JE, Alvarez C, Garcia-Hermoso A. Exercise and postprandial lipemia: effects on vascular health in inactive adults. Lipids Health Dis. 2018 Apr 3;17(1):69. doi: 10.1186/s12944-018-0719-3.
Results Reference
derived
PubMed Identifier
28558739
Citation
Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Similar cardiometabolic effects of high- and moderate-intensity training among apparently healthy inactive adults: a randomized clinical trial. J Transl Med. 2017 May 30;15(1):118. doi: 10.1186/s12967-017-1216-6. Erratum In: J Transl Med. 2017 Jun 13;15(1):136.
Results Reference
derived
PubMed Identifier
28198783
Citation
Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Effect of Moderate- Versus High-Intensity Interval Exercise Training on Heart Rate Variability Parameters in Inactive Latin-American Adults: A Randomized Clinical Trial. J Strength Cond Res. 2020 Dec;34(12):3403-3415. doi: 10.1519/JSC.0000000000001833.
Results Reference
derived

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Intensity Training and Cardiovascular Health in Colombian Adults

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