NCT02288403

Brief Summary

Aerobic exercise produces increases in cardiorespiratory fitness (CF), which constitute a protective factor for cardiovascular disease and all-cause mortality. Therefore, aerobic exercise is a key strategy to promoting cardiovascular. There is some evidence that aerobic high intensity interval training may lead to greater increases in CF compared with continuous moderate-intensity training. The main objective of this study is to examine the effects of an aerobic high intensity training program versus a continuous moderate intensity training program on CF in men 18 to 44 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable healthy-volunteers

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

First Submitted

Initial submission to the registry

November 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 24, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

November 4, 2014

Last Update Submit

June 22, 2016

Conditions

Healthy Volunteers

Keywords

Aerobic ExerciseOxygen ConsumptionBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • Change in maximal oxygen uptake

    Baseline and 8-weeks

Secondary Outcomes (2)

  • Change in systolic blood pressure

    Baseline and 8-weeks

  • Change in diastolic blood pressure

    Baseline and 8-weeks

Study Arms (2)

Aerobic interval training

EXPERIMENTAL

Interval exercise at an intensity between 90-95% of maximum heart rate (15x30 s), with recoveries at an equivalent speed to 50-55 % of maximal oxygen consumption at baseline (14x60 s). 24 training sessions, 3x weekly (on alternate days).

Behavioral: Aerobic interval training

Continuous training

ACTIVE COMPARATOR

40 minutes of continuous exercise at an intensity between 65-75% of maximum heart rate. 24 training sessions, 3x weekly (on alternate days).

Behavioral: Continuous training

Interventions

Aerobic interval trainingBEHAVIORAL
Aerobic interval training
Continuous trainingBEHAVIORAL
Continuous training

Eligibility Criteria

Age18 Years - 44 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Perform aerobic exercise maximum 3 sessions per week

You may not qualify if:

  • Currently participating in an aerobic high intensity training program
  • Smoker
  • History of cardiovascular disease
  • History of coronary heart disease
  • Arrhythmias
  • Heart failure/insufficiency
  • Hypertension
  • Diabetes
  • Under medical treatment with anticoagulants, beta-blockers, calcium antagonists, bronchodilators, and/or steroids
  • Psychological, neuromotor and/or osteo-muscular conditions that may affect participation in an exercise program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Antioquia

Medellín, Antioquia, Colombia

Location

Related Publications (2)

  • Arboleda-Serna VH, Feito Y, Patino-Villada FA, Vargas-Romero AV, Arango-Velez EF. Effects of high-intensity interval training compared to moderate-intensity continuous training on maximal oxygen consumption and blood pressure in healthy men: A randomized controlled trial. Biomedica. 2019 Sep 1;39(3):524-536. doi: 10.7705/biomedica.4451.

    PMID: 31584766DERIVED

  • Arboleda Serna VH, Arango Velez EF, Gomez Arias RD, Feito Y. Effects of a high-intensity interval training program versus a moderate-intensity continuous training program on maximal oxygen uptake and blood pressure in healthy adults: study protocol for a randomized controlled trial. Trials. 2016 Aug 18;17:413. doi: 10.1186/s13063-016-1522-y.

    PMID: 27538896DERIVED

Study Officials

  • Víctor H Arboleda, MSc

    Associate Professor

    PRINCIPAL INVESTIGATOR

  • Elkin F Arango, MD. MSc

    Associate Professor

    PRINCIPAL INVESTIGATOR

  • Rubén D Gómez, PhD. MD

    Professor

    PRINCIPAL INVESTIGATOR

  • Yuri Feito, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 11, 2014

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 24, 2016

Record last verified: 2016-06

Locations

CO(1)