NCT05619874

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
terminated

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

September 5, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

November 9, 2022

Last Update Submit

October 1, 2024

Conditions

Keywords

High-intensity functional circuit trainingVirtual exerciseObesityIntra-abdominal fatWaist circumferenceBody composition

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 10-weeks

Secondary Outcomes (1)

  • Change in waist circumference

    Baseline and 10-weeks

Other Outcomes (1)

  • Fat mass, fat-free mass, whole-body and segmental skeletal muscle mass.

    Baseline and 10-weeks

Study Arms (2)

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).

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).

Behavioral: HIFCT-P

Interventions

HIFCT-SBEHAVIORAL

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-S
HIFCT-PBEHAVIORAL

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.

HIFCT-P

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women and men.
  • Physical activity (\<600 to ≤1500 MET/min/wk).
  • Waist circumference (≥87cm).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Formación en Actividad Física y Cultura-SENA Distrito Capital

Bogotá, Cundinamarca, Colombia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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
Principal Investigator

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 17, 2022

Study Start

September 5, 2022

Primary Completion

November 15, 2023

Study Completion

November 15, 2023

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations