Healthy VolunteersHIFCT-VNCT05619874
Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity
A study testing HIFCT-S and HIFCT-P in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
It is estimated that by 2030 one in five women and one in seven men will be obese, equivalent to more than 1 billion people around the world. It should be noted that the largest number of people with obesity live in countries with low and moderate-income. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- HIFCT-S and HIFCT-P
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteColombia
- Study dates
- 5 Sep 2022to 15 Nov 2023
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women and men.
- Physical activity (<600 to ≤1500 MET/min/wk).
- Waist circumference (≥87cm).
Who cannot join
- Have performed high intensity exercises or HIFCT in the last two months.
- Smoking.
- History of cardiovascular disease.
- History of coronary heart disease.
- Pregnancy.
- Breast-feeding women.
- Psychological, neuromotor, and/or osteo-muscular conditions that may affect participation in an exercise program.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Centro de Formación en Actividad Física y Cultura-SENA Distrito Capital
Bogotá, Cundinamarca
About this study
Official title: Effects of Two Virtual High-intensity Functional Circuit Training Programs on Intra-abdominal Fat, Body Composition, Health-related Quality of Life, and Some Components of Physical Fitness in Adults With Abdominal Obesity
It is estimated that by 2030 one in five women and one in seven men will be obese, equivalent to more than 1 billion people around the world. It should be noted that the largest number of people with obesity live in countries with low and moderate-income. In 2019, more than 160 million years of healthy life were lost in the world, due to a high body mass index (BMI), this represents more than 20% of all years of healthy life lost due to chronic diseases. Therefore, it is essential to stop the increase in obesity and reduce it at all ages, which demands comprehensive actions at the global level. Scientific evidence suggests that people with a normal BMI, but with abdominal obesity, have a higher mortality risk compared to those with a similar or even higher BMI. In addition, visceral adiposity has been associated with worse survival and with colorectal cancer.
Several methods of physical exercise have been used to counteract the adverse effects of obesity, including high-intensity functional circuit training (HIFCT). Scientific evidence indicates that HIFCT reduces fat mass, body mass, BMI, and waist circumference and improves muscle strength, maximal oxygen uptake, and health-related quality of life in overweight, obese, inactive, and with other diseases. However, no research assessed intra-abdominal fat (IAF), which, more than subcutaneous fat, is associated with cardiovascular risk factors. In addition, these studies had important methodological limitations. Therefore, the primary purpose of this study is to identify the effect of two HIFCT protocols, prolonged load (HIFCT-P) and short load (HIFCT-S), performed in a virtual environment for ten weeks on intra-abdominal fat in people between 18-40 years-old with abdominal obesity.
Read the detailed description
A randomized controlled trial with parallel arms (HIFCT-P and HIFCT-C) based on a non-inferiority hypothesis comparing two proportions. Each participant will carry out 30 sessions, three times a week, in a virtual environment. General, concentrated, and block circuits will be used, with the same exercises, but with different load distribution and different order between them. Both HIFCT-P and HIFCT-S will carry out six initial adaptation sessions through a general circuit composed of 12 exercises. Different muscle groups will be alternated. The exercises will be performed at speeds between 35 and 55 beats per minute (bpm), to ensure intensities between 50% - 60% in sessions 1 to 3, and between 70% - 80% in sessions 4 to 6. The Modified Borg Rating of Perceived Exertion Scale (RPE) will be used to control intensities. From session seven to session 30, HIFCT-P and HIFCT-S will perform the same exercises but with a different load distribution.
- Conditions
- Healthy Volunteers
- Being tested
- HIFCT-S, HIFCT-P
- Keywords
- High-intensity functional circuit training, Virtual exercise, Obesity, Intra-abdominal fat, Waist circumference, Body composition
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFCT-SBehavioural
A functional circuit training of 30 sessions will be carried out as follows:
- Sessions 1 to 6: General circuit (two series) composed of four blocks of three exercises.
- Sessions 7 to 14: Concentrated circuit (two sets) composed of four blocks of three exercises of greater complexity than the exercises of the general circuit.
- Sessions 15 to 22: Circuit by blocks (two sets) composed of four blocks of two exercises of greater complexity than the exercises from sessions 7 to 14.
- Sessions 23 to 30: Circuit by blocks (two sets) composed of four blocks of two exercises of greater complexity than the exercises from sessions 15 to 22.
HIFCT-PBehavioural
A functional circuit training of 30 sessions will be carried out as follows:
- Sessions 1 to 6: General circuit (two series) composed of two blocks of 6 exercises.
- Sessions 7 to 14: Concentrated circuit (two sets) composed of two blocks of 6 exercises of greater complexity than the exercises of the general circuit.
- Sessions 15 to 22: Circuit by blocks (single set) composed of five blocks of two exercises of greater complexity than the exercises from sessions 7 to 14.
- Sessions 23 to 30: Circuit by blocks (single set) composed of five blocks of two exercises of greater complexity than the exercises from sessions 15 to 22.
| Study group | Role | What they receive |
|---|---|---|
| HIFCT-S | Experimental | For sessions 7 to 14, a concentrated circuit divided into four blocks of three exercises will be carried out, with a duration of 40 seconds per exercise with no rest between them. A rest of 120 seconds will be given at the end of each block, and a rest of the same time at the end of the first set. Two sets will be executed, which will result in a total time of 30 minutes including rest. For sessions 15 to 30, four blocks of two exercises will be performed, with a duration of 60 seconds per exercise, with no rest between them. The rest between blocks will be 120 seconds. Two sets will be performed, for a total time of 30 minutes including breaks. The exercises will be performed at speeds between 35 and 75 bpm. The intensity will be between 80% - 90% (8-9 RPE). Receives: Behavioral: HIFCT-S |
| HIFCT-P | Active comparator | For sessions 7 to 14, a concentrated circuit divided into two blocks of six exercises will be carried out, with a duration of 60 seconds per exercise with no rest between them. A rest of 120 seconds will be given at the end of each block, and a rest of the same time at the end of the first set. Two sets will be executed, which will result in a total time of 30 minutes including rest.
For sessions 15 to 30, five blocks of two exercises will be performed, with a duration of 120 seconds per exercise, with no rest between them. The rest between blocks will be 120 seconds. The total time per block is four minutes, for a total time of 30 minutes including breaks. The exercises will be performed at speeds between 35 and 75 bpm. The intensity will be between 80% - 90% (8-9 RPE). Receives: Behavioral: HIFCT-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intra-abdominal fat
Body Composition Analyzer Seca mBCA 515. The measurement results allow estimating intra-abdominal fat in liters. Values <27 L are considered normal, >27 L to <43 L are considered elevated, and ≥43 L are considered high. Individuals will be instructed to wear light clothing, and stand barefoot on the device, following manufacturer protocols.All assessments will take place at the same time of day.
Measured: Baseline and 10-weeks
Secondary outcomes (1)
Change in waist circumference
A flexible tape measure: Waist circumference will be measured following standard procedures, at the mid-point between the lower costal edge and the iliac crest. (Klein et al., 2007 https://doi.org/10.1093/ajcn/85.5.1197)
Measured: Baseline and 10-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start5 Sep 2022
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Why it stopped: The study was suspended due to the inability to complete the sample after more than a year of attempts. Various adherence strategies were tested, but adherence to the interventions remained too low.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 12 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
- NCT05619874
- Sponsor's protocol ID
- Virtual HIFCT-UdeA-SENA_DC
- Acronym
- HIFCT-V
- Status last verified
- Oct 2024
- First submitted
- 9 Nov 2022
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Virtual High-intensity Functional Circuit Training Programs on Intra-abdominal Fat, Body Composition, Health-related Quality of Life, and Some Components of Physical Fitness in Adults With Abdominal Obesity
- ClinicalTrials.gov ID
- NCT05619874
- Acronym / sponsor ID
- HIFCT-V / Virtual HIFCT-UdeA-SENA_DC
- Conditions
- Healthy Volunteers
- Keywords
- High-intensity functional circuit training, Virtual exercise, Obesity, Intra-abdominal fat, Waist circumference, Body composition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was suspended due to the inability to complete the sample after more than a year of attempts. Various adherence strategies were tested, but adherence to the interventions remained too low.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 17 Nov 2022 (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.
It is estimated that by 2030 one in five women and one in seven men will be obese, equivalent to more than 1 billion people around the world. It should be noted that the largest number of people with obesity live in countries with low and moderate-income. In 2019, more than 160 million years of healthy life were lost in the world, due to a high body mass index (BMI), this represents more than 20% of all years of healthy life lost due to chronic diseases. Therefore, it is essential to stop the increase in obesity and reduce it at all ages, which demands comprehensive actions at the global level. Scientific evidence suggests that people with a normal BMI, but with abdominal obesity, have a higher mortality risk compared to those with a similar or even higher BMI. In addition, visceral adiposity has been associated with worse survival and with colorectal cancer.
Several methods of physical exercise have been used to counteract the adverse effects of obesity, including high-intensity functional circuit training (HIFCT). Scientific evidence indicates that HIFCT reduces fat mass, body mass, BMI, and waist circumference and improves muscle strength, maximal oxygen uptake, and health-related quality of life in overweight, obese, inactive, and with other diseases. However, no research assessed intra-abdominal fat (IAF), which, more than subcutaneous fat, is associated with cardiovascular risk factors. In addition, these studies had important methodological limitations. Therefore, the primary purpose of this study is to identify the effect of two HIFCT protocols, prolonged load (HIFCT-P) and short load (HIFCT-S), performed in a virtual environment for ten weeks on intra-abdominal fat in people between 18-40 years-old with abdominal obesity.
Detailed description
A randomized controlled trial with parallel arms (HIFCT-P and HIFCT-C) based on a non-inferiority hypothesis comparing two proportions. Each participant will carry out 30 sessions, three times a week, in a virtual environment. General, concentrated, and block circuits will be used, with the same exercises, but with different load distribution and different order between them. Both HIFCT-P and HIFCT-S will carry out six initial adaptation sessions through a general circuit composed of 12 exercises. Different muscle groups will be alternated. The exercises will be performed at speeds between 35 and 55 beats per minute (bpm), to ensure intensities between 50% - 60% in sessions 1 to 3, and between 70% - 80% in sessions 4 to 6. The Modified Borg Rating of Perceived Exertion Scale (RPE) will be used to control intensities. From session seven to session 30, HIFCT-P and HIFCT-S will perform the same exercises but with a different load distribution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIFCT-S | Experimental | Behavioral: HIFCT-SFor sessions 7 to 14, a concentrated circuit divided into four blocks of three exercises will be carried out, with a duration of 40 seconds per exercise with no rest between them. A rest of 120 seconds will be given at the end of each block, and a rest of the same time at the end of the first set. Two sets will be executed, which will result in a total time of 30 minutes including rest. For sessions 15 to 30, four blocks of two exercises will be performed, with a duration of 60 seconds per exercise, with no rest between them. The rest between blocks will be 120 seconds. Two sets will be performed, for a total time of 30 minutes including breaks. The exercises will be performed at speeds between 35 and 75 bpm. The intensity will be between 80% - 90% (8-9 RPE). |
| HIFCT-P | Active comparator | Behavioral: HIFCT-PFor sessions 7 to 14, a concentrated circuit divided into two blocks of six exercises will be carried out, with a duration of 60 seconds per exercise with no rest between them. A rest of 120 seconds will be given at the end of each block, and a rest of the same time at the end of the first set. Two sets will be executed, which will result in a total time of 30 minutes including rest. For sessions 15 to 30, five blocks of two exercises will be performed, with a duration of 120 seconds per exercise, with no rest between them. The rest between blocks will be 120 seconds. The total time per block is four minutes, for a total time of 30 minutes including breaks. The exercises will be performed at speeds between 35 and 75 bpm. The intensity will be between 80% - 90% (8-9 RPE). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women and men.
- Physical activity (<600 to ≤1500 MET/min/wk).
- Waist circumference (≥87cm).
Key exclusion criteria (7 listed)
- Have performed high intensity exercises or HIFCT in the last two months.
- Smoking.
- History of cardiovascular disease.
- History of coronary heart disease.
- Pregnancy.
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 |
|---|---|---|
| HIFCT-SA functional circuit training of 30 sessions will be carried out as follows: * Sessions 1 to 6: General circuit (two series) composed of four blocks of three exercises. * Sessions 7 to 14: Concentrated circuit (two sets) composed of four blocks of three exercises of greater complexity than the exercises of the general circuit. * Sessions 15 to 22: Circuit by blocks (two sets) composed of four blocks of two exercises of greater complexity than the exercises from sessions 7 to 14. * Sessions 23 to 30: Circuit by blocks (two sets) composed of four blocks of two exercises of greater complexity than the exercises from sessions 15 to 22. | Behavioural | HIFCT-S |
| HIFCT-PA functional circuit training of 30 sessions will be carried out as follows: * Sessions 1 to 6: General circuit (two series) composed of two blocks of 6 exercises. * Sessions 7 to 14: Concentrated circuit (two sets) composed of two blocks of 6 exercises of greater complexity than the exercises of the general circuit. * Sessions 15 to 22: Circuit by blocks (single set) composed of five blocks of two exercises of greater complexity than the exercises from sessions 7 to 14. * Sessions 23 to 30: Circuit by blocks (single set) composed of five blocks of two exercises of greater complexity than the exercises from sessions 15 to 22. | Behavioural | HIFCT-P |
Primary outcome
Change in intra-abdominal fat
Time frame: Baseline and 10-weeks
Body Composition Analyzer Seca mBCA 515. The measurement results allow estimating intra-abdominal fat in liters. Values <27 L are considered normal, >27 L to <43 L are considered elevated, and ≥43 L are considered high. Individuals will be instructed to wear light clothing, and stand barefoot on the device, following manufacturer protocols.All assessments will take place at the same time of day.
1 secondary outcome
Change in waist circumference
Time frame: Baseline and 10-weeks
Results and safety
The study was stopped early (reason given: The study was suspended due to the inability to complete the sample after more than a year of attempts. Various adherence strategies were tested, but adherence to the interventions remained too low.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- 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 HIFCT-S and HIFCT-P 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 7 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: stopped early, as of the sponsor's last update on 3 Oct 2024. 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 was stopped early (reason given: The study was suspended due to the inability to complete the sample after more than a year of attempts. Various adherence strategies were tested, but adherence to the interventions remained too low.). Results are not available in the source record.
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 intra-abdominal fat (time frame: Baseline and 10-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024.