NCT02738385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

March 23, 2016

Last Update Submit

October 24, 2016

Conditions

Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (14)

  • Change from Baseline in LDL Cholesterol

    Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.

  • Change from Baseline in HDL Cholesterol

    Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.

  • Change from Baseline in Triglycerides

    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.

  • +9 more secondary outcomes

Study Arms (2)

High Intensity Interval Training

EXPERIMENTAL

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

Moderate Intensity Interval Training

ACTIVE COMPARATOR

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

Interventions

High Intensity Interval TrainingBEHAVIORAL

Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.

High Intensity Interval Training
Moderate Intensity Interval TrainingBEHAVIORAL

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

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent.
  • Interested in improving health and fitness.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robinson Ramírez Vélez Ph.D

Bogotá, Colombia

Location

Related Publications (4)

  • 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.

    PMID: 30717757DERIVED

  • 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.

    PMID: 29615070DERIVED

  • 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.

    PMID: 28558739DERIVED

  • 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.

    PMID: 28198783DERIVED

MeSH Terms

Conditions

Metabolic Diseases

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Robinson Ramírez Vélez, Ph.D

    Universidad del Rosario

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Professor. Center of Studies in Physical Activity Measurements, School of Medicine and Health Sciences

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 14, 2016

Study Start

June 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)