Healthy VolunteersNCT03300895
High-intensity Interval Training on Cardiorespiratory Fitness in Overweight Women
A study testing High-intensity interval training and Comparator: Moderate-intensity continuous exercise in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
High-intensity interval training (HIIT) is currently considered one of the most effective strategies to improved cardiorespiratory fitness, which is recognized as a protective factor for cardiovascular diseases and metabolic diseases such as overweight and obesity. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- High-intensity interval training and Comparator: Moderate-intensity continuous exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteColombia
- Study dates
- 14 Aug 2017to 30 Nov 2018
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight (≥ 25 kg/m-2) women 18 to 44 years.
- Healthy volunteers.
- Perform ≤ 600 Met/min/week.
Who cannot join
- Perform high-intensity interval exercise in the last six month.
- Smoker.
- History of asthma.
- History of diabetes.
- History of hypertension.
- History of cardiovascular disease.
Show all 13Show fewer
- History of coronary heart disease.
- Arrhythmias.
- Personal history of surgical procedures in the last three months
- Uncontrolled non-communicable diseases
- 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.
- Psychoactive drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-volume High-intensity Interval Training on Cardiorespiratory Fitness and Total Body Fat in Overweight Women
High-intensity interval training (HIIT) is currently considered one of the most effective strategies to improved cardiorespiratory fitness, which is recognized as a protective factor for cardiovascular diseases and metabolic diseases such as overweight and obesity. However, current evidence is still limited and requires clarity (frequency, time per session and intensity) regarding to greater increases attributed to HIIT.
The aim of this study is to compare the effect of a low-volume high-intensity interval training versus a moderate-intensity continuous exercise on maximal oxygen consumption in overweight women 18 to 44 years old.
Read the detailed description
Thirty-six women will be randomly assigned to one of two aerobic exercise on a real-life setting supervised for a physical activity instructor. The interventions will performed three times a week for ten-weeks (on alternate days).
The first two weeks will correspond to the conditioning period (30 minutes between 55-65% of maximum heart rate (HRmax). From week three, 18 participants will perform 30 minutes of continuous exercise at an intensity between 65-75 % of HRmax, and the remaining 18 will complete 21.5 minutes of interval exercise at an intensity between 90-95% of HRmax, with recoveries between 50-55% of HRmax.
All Participants will be evaluated to measure their maximal oxygen consumption, total body fat, waist circumference, body mass index, systolic blood pressure, diastolic blood pressure, prior to start the interventions and at the end of the program (week 11).
- Conditions
- Healthy Volunteers
- Being tested
- High-intensity interval training, Comparator: Moderate-intensity continuous exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingOther
21.5 minutes of high-intensity interval exercise at an intensity between 90-95 of HRmax (15x30 s), with recoveries at 50-60% of HRmax (14x60 s). 24 sessions, 3x weekly of walking and running outdoors on a sports field in a supervised manner.
Comparator: Moderate-intensity continuous exerciseOther
30 minutes of continuous exercise at an intensity between 65-75% of HRmax. 24 sessions, 3x weekly of walking and jogging outdoors on a sports field in a supervised manner
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training | Experimental | Not described Receives: Other: High-intensity interval training |
| Moderate-intensity continuous exercise | Active comparator | Not described Receives: Other: Comparator: Moderate-intensity continuous exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal oxygen consumption
Maximal oxygen consumption will be obtained using a graded exercise test on a treadmill (Trackmaster® model TMX 425C) using a portable K4b2 gas analyzer (Cosmed Inc., IL, USA)
Measured: Baseline and after 10 weeks
Secondary outcomes (1)
Change in total body fat
Total body fat will be obtained using an Omron® HBF-510 (Omron Healthcare, Inc. Bannockburn, IL, USA) bioelectrical impedance machine.
Measured: Baseline and after 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start14 Aug 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 35 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300895
- Sponsor's protocol ID
- HIIT2-AFIS-UdeA
- Status last verified
- Feb 2019
- First submitted
- 28 Sep 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arboleda-Serna VH, Patino-Villada FA, Pinzon-Castro DA, Arango-Velez EF. Effects of low-volume, high-intensity interval training on maximal oxygen consumption, body fat percentage and health-related quality of life in women with overweight: A randomized controlled trial. J Exerc Sci Fit. 2022 Apr;20(2):108-112. doi: 10.1016/j.jesf.2022.01.004. Epub 2022 Feb 4.
PubMed 35228846
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-volume High-intensity Interval Training on Cardiorespiratory Fitness and Total Body Fat in Overweight Women
- ClinicalTrials.gov ID
- NCT03300895
- Acronym / sponsor ID
- HIIT2-AFIS-UdeA
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 4 Oct 2017 (actual)
- 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.
High-intensity interval training (HIIT) is currently considered one of the most effective strategies to improved cardiorespiratory fitness, which is recognized as a protective factor for cardiovascular diseases and metabolic diseases such as overweight and obesity. However, current evidence is still limited and requires clarity (frequency, time per session and intensity) regarding to greater increases attributed to HIIT.
The aim of this study is to compare the effect of a low-volume high-intensity interval training versus a moderate-intensity continuous exercise on maximal oxygen consumption in overweight women 18 to 44 years old.
Detailed description
Thirty-six women will be randomly assigned to one of two aerobic exercise on a real-life setting supervised for a physical activity instructor. The interventions will performed three times a week for ten-weeks (on alternate days).
The first two weeks will correspond to the conditioning period (30 minutes between 55-65% of maximum heart rate (HRmax). From week three, 18 participants will perform 30 minutes of continuous exercise at an intensity between 65-75 % of HRmax, and the remaining 18 will complete 21.5 minutes of interval exercise at an intensity between 90-95% of HRmax, with recoveries between 50-55% of HRmax.
All Participants will be evaluated to measure their maximal oxygen consumption, total body fat, waist circumference, body mass index, systolic blood pressure, diastolic blood pressure, prior to start the interventions and at the end of the program (week 11).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Other: High-intensity interval training |
| Moderate-intensity continuous exercise | Active comparator | Other: Comparator: Moderate-intensity continuous exercise |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Overweight (≥ 25 kg/m-2) women 18 to 44 years.
- Healthy volunteers.
- Perform ≤ 600 Met/min/week.
Key exclusion criteria (13 listed)
- Perform high-intensity interval exercise in the last six month.
- Smoker.
- History of asthma.
- History of diabetes.
- History of hypertension.
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 |
|---|---|---|
| High-intensity interval training21.5 minutes of high-intensity interval exercise at an intensity between 90-95 of HRmax (15x30 s), with recoveries at 50-60% of HRmax (14x60 s). 24 sessions, 3x weekly of walking and running outdoors on a sports field in a supervised manner. | Other | High-intensity interval training |
| Comparator: Moderate-intensity continuous exercise30 minutes of continuous exercise at an intensity between 65-75% of HRmax. 24 sessions, 3x weekly of walking and jogging outdoors on a sports field in a supervised manner | Other | Moderate-intensity continuous exercise |
Primary outcome
Change in maximal oxygen consumption
Time frame: Baseline and after 10 weeks
Maximal oxygen consumption will be obtained using a graded exercise test on a treadmill (Trackmaster® model TMX 425C) using a portable K4b2 gas analyzer (Cosmed Inc., IL, USA)
1 secondary outcome
Change in total body fat
Time frame: Baseline and after 10 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 4 Feb 2019.
- Derived from this study: PubMed 35228846Arboleda-Serna VH, Patino-Villada FA, Pinzon-Castro DA, Arango-Velez EF. Effects of low-volume, high-intensity interval training on maximal oxygen consumption, body fat percentage and health-related quality of life in women with overweight: A randomized controlled trial. J Exerc Sci Fit. 2022 Apr;20(2):108-112. doi: 10.1016/j.jesf.2022.01.004. Epub 2022 Feb 4.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training and Comparator: Moderate-intensity continuous exercise 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 3 inclusion and 13 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 4 Feb 2019. 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 consumption (time frame: Baseline and after 10 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 NCT03300895, which also lists 1 linked publication.
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 4 Feb 2019.