Healthy VolunteersNCT02288403
Interval Versus Continuous Training in Healthy Adults
A study testing Aerobic interval training and Continuous training in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Aerobic interval training and Continuous training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteColombia
- Study dates
- Apr 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Perform aerobic exercise maximum 3 sessions per week
Who cannot join
- Currently participating in an aerobic high intensity training program
- Smoker
- History of cardiovascular disease
- History of coronary heart disease
- Arrhythmias
- Heart failure/insufficiency
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a High-intensity Interval Training Program Compared to a Moderate Intensity Program in Adults 18-44 Years
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.
Read the detailed description
Forty-four individuals will be randomly assigned to one of two aerobic training programs on a treadmill. Both groups will performed three times a week for eight-weeks (on alternate days). Half will run 40 minutes of continuous exercise at an intensity between 65-75% of maximum heart rate, and the remaining 22 will complete 21.5 minutes of interval exercise at an intensity between 90-95% of maximum heart rate, with recoveries between 50-55 % of maximum heart rate. After each session both groups will complete eight strength exercises mainly including large muscle groups for two sets and 8-12 repetitions at an intensity equivalent to 60-70% of one repetition maximum (controlled by perceived effort). Rest between sets will be kept between 60 and 90 seconds.
All participants will be evaluated at the start and completion of the intervention for their maximal oxygen consumption, blood pressure, waist circumference, BMI, body composition, and steps per week.
- Conditions
- Healthy Volunteers
- Being tested
- Aerobic interval training, Continuous training
- Keywords
- Aerobic Exercise, Oxygen Consumption, Blood Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic interval trainingBehavioural
Continuous trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Continuous training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal oxygen uptake
Measured: Baseline and 8-weeks
Secondary outcomes (2)
Change in systolic blood pressure
Measured: Baseline and 8-weeks
Change in diastolic blood pressure
Measured: Baseline and 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Arboleda Serna, Universidad de Antioquia
- Investigators
- Víctor H Arboleda, MSc, Principal investigator, Associate ProfessorElkin F Arango, MD. MSc, Principal investigator, Associate ProfessorRubén D Gómez, PhD. MD, Principal investigator, ProfessorYuri Feito, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288403
- Sponsor's protocol ID
- HIIT-1-UdeA
- Status last verified
- Jun 2016
- First submitted
- 4 Nov 2014
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31584766Arboleda 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.
PubMed 27538896
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a High-intensity Interval Training Program Compared to a Moderate Intensity Program in Adults 18-44 Years
- ClinicalTrials.gov ID
- NCT02288403
- Acronym / sponsor ID
- HIIT-1-UdeA
- Conditions
- Healthy Volunteers
- Keywords
- Aerobic Exercise, Oxygen Consumption, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Forty-four individuals will be randomly assigned to one of two aerobic training programs on a treadmill. Both groups will performed three times a week for eight-weeks (on alternate days). Half will run 40 minutes of continuous exercise at an intensity between 65-75% of maximum heart rate, and the remaining 22 will complete 21.5 minutes of interval exercise at an intensity between 90-95% of maximum heart rate, with recoveries between 50-55 % of maximum heart rate. After each session both groups will complete eight strength exercises mainly including large muscle groups for two sets and 8-12 repetitions at an intensity equivalent to 60-70% of one repetition maximum (controlled by perceived effort). Rest between sets will be kept between 60 and 90 seconds.
All participants will be evaluated at the start and completion of the intervention for their maximal oxygen consumption, blood pressure, waist circumference, BMI, body composition, and steps per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic interval training | Experimental | Behavioral: Aerobic interval trainingInterval 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). |
| Continuous training | Active comparator | Behavioral: Continuous training40 minutes of continuous exercise at an intensity between 65-75% of maximum heart rate. 24 training sessions, 3x weekly (on alternate days). |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Perform aerobic exercise maximum 3 sessions per week
Key exclusion criteria (10 listed)
- Currently participating in an aerobic high intensity training program
- Smoker
- History of cardiovascular disease
- History of coronary heart disease
- Arrhythmias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic interval training | Behavioural | Aerobic interval training |
| Continuous training | Behavioural | Continuous training |
Primary outcome
Change in maximal oxygen uptake
Time frame: Baseline and 8-weeks
2 secondary outcomes
Change in systolic blood pressure
Time frame: Baseline and 8-weeks
Change in diastolic blood pressure
Time frame: Baseline and 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Derived from this study: PubMed 31584766Arboleda-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.
- Derived from this study: PubMed 27538896Arboleda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Víctor H Arboleda, MSc principal investigator
Associate Professor
Elkin F Arango, MD. MSc principal investigator
Associate Professor
Rubén D Gómez, PhD. MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic interval training and Continuous training in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximal oxygen uptake (time frame: Baseline and 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02288403, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.