Effects of Polarized Exercise in Adolescents With Severe Obesity (ALPOLAROB)

NCT ID: NCT05763394

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Recent studies have shown that polarized training (i.e. the combination in the same session of intermittent high intensity exercise training, consisting of repeated, short-duration, high-intensity exercises on a cycle ergometer or a treadmill, and moderate exercise) can encourage the participation of obese people in body weight reduction programs, providing more dynamic exercises, less tiring and therefore more acceptable.

To date, no data are available on the effects of polarized exercise in the rehabilitation of obese adolescents, who are often unwilling to engage in prolonged and monotonous motor activities.

The demonstration that the polarized exercise might encourage the participation of obese adolescents in multidisciplinary body weight reduction programs, improve the cardiovascular capacity and also favor an adequate oxidation of lipids during the phase of exercise and post-exercise rest, could support its prescription in the programs of integrated metabolic rehabilitation of adolescent obesity.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjects 24 obese adolescents (BMI-standard deviation score \> 2), male, age range: 13-18 years, admitted to the Division of Auxology, San Giuseppe Hospital, Istituto Auxologico Italiano, Piancavallo (VB) for a 3-week metabolic rehabilitation program.

Measures:

In basal conditions (hospital admission) and at the end of the metabolic rehabilitation period (21st day), the anthropometric characteristics and body composition will be evaluated by means of tetrapolar impedancemetry (Human-IM Scan, DS-Medigroup, Milan, Italy). In basal conditions all the recruited subjects will undergo an incremental test on a treadmill aimed at determining the maximum lipid oxidation, the peak oxygen consumption value (peak V'O2), and the intensities corresponding to the various percentages of the V' Peak O2 (Medical graphics Corporation, St Paul, MN, USA). Subsequently, subjects will be randomly divided into two groups. The first group (no. 12) will perform a Polarized workout lasting approximately 40 minutes (two sessions/day, 1 in the morning and 1 in the afternoon, 5 days a week), characterized by a 5-minute warm-up performed at 50% of the V 'peak O2, followed by 3 sets of 2 minutes at 95% of peak V'O2, interspersed with 1 minute of recovery at 40% of peak V'O2, followed by 30 minutes of moderate activity at 60% of V'O2 'O2 peak. The second group (no. 12) will perform two sessions (one in the morning and one in the afternoon, 5 days a week) of a high intensity workout (HIIT) characterized by a 10-minute warm-up performed at 50% of peak V'O2 , followed by 6 series of 40 s of high-intensity walking corresponding to 95% of peak V'O2, interspersed with 5 minutes of walking at 40% of peak V'O2, ending with 5' of cool-down at 50% of the peak V'O2. Both workouts (24 sessions in total, spread over 12 days) will be matched for the same calories expended. At the end of the rehabilitation period, all subjects will again be subjected to an incremental test on a conveyor belt with the same execution methods as for the baseline test.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Exercise Training

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Polarized workout

Group Type EXPERIMENTAL

Polarized workout program

Intervention Type OTHER

Polarized workout lasting approximately 40 minutes (two sessions/day, 5 days a week), characterized by a 5-minute warm-up performed at 50% of the peak V'O2, followed by 3 sets of 2 minutes at 95% of peak V'O2, interspersed with 1 minute of recovery at 40% of peak V'O2, followed by 30 minutes of moderate activity at 60% of V'O2 peak. Total of 24 sessions in 12 days.

High intensity workout

Group Type EXPERIMENTAL

High intensity workout program

Intervention Type OTHER

High intensity workout (HIIT) (two sessions/day, 5 days a week), characterized by a 10-minute warm-up performed at 50% of peak V'O2 , followed by 6 series of 40 s of high-intensity walking corresponding to 95% of peak V'O2, interspersed with 5 minutes of walking at 40% of peak V'O2, ending with 5' of cool-down at 50% of the peak V'O2. Total of 24 sessions in 12 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Polarized workout program

Polarized workout lasting approximately 40 minutes (two sessions/day, 5 days a week), characterized by a 5-minute warm-up performed at 50% of the peak V'O2, followed by 3 sets of 2 minutes at 95% of peak V'O2, interspersed with 1 minute of recovery at 40% of peak V'O2, followed by 30 minutes of moderate activity at 60% of V'O2 peak. Total of 24 sessions in 12 days.

Intervention Type OTHER

High intensity workout program

High intensity workout (HIIT) (two sessions/day, 5 days a week), characterized by a 10-minute warm-up performed at 50% of peak V'O2 , followed by 6 series of 40 s of high-intensity walking corresponding to 95% of peak V'O2, interspersed with 5 minutes of walking at 40% of peak V'O2, ending with 5' of cool-down at 50% of the peak V'O2. Total of 24 sessions in 12 days.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

i. obesity (BMI-standard deviation score \> 2) ii. sex: male iii. age range: 13-18 years iv. hospitalization for integrated metabolic rehabilitation program

Exclusion Criteria

None
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01C212

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exercise and Ectopic Fat Deposition
NCT02831621 COMPLETED NA
Physical Activity and Health Outcomes
NCT01833507 COMPLETED PHASE2/PHASE3