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

Sponsor
Istituto Auxologico Italiano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05763394
Collaborator
(none)
24
1
2
17.9
1.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Polarized workout program
  • Other: High intensity workout program
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
Effects of Polarized Exercise on Cardiovascular Capacity and Lipid Metabolism in Adolescents With Severe Obesity
Actual Study Start Date :
Jul 4, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Polarized workout

Other: 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.

Experimental: High intensity workout

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.

Outcome Measures

Primary Outcome Measures

  1. Peak VO2 [Baseline and at the end of the rehabilitation program (21 days)]

    Change in peak VO2

Secondary Outcome Measures

  1. Body fat mass [Baseline and at the end of the rehabilitation program (21 days)]

    Change in body fat mass - bioimpedance analysis

  2. Body fat free mass [Baseline and at the end of the rehabilitation program (21 days)]

    Change in body fat free mass - bioimpedance analysis

  3. Body weight [Baseline and at the end of the rehabilitation program (21 days)]

    Change in body weight

  4. Body mass index [Baseline and at the end of the rehabilitation program (21 days)]

    Change in body mass index

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 18 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istituto Auxologico Italiano IRCCS, Site Piancavallo Oggebbio Verbania Italy 28824

Sponsors and Collaborators

  • Istituto Auxologico Italiano

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT05763394
Other Study ID Numbers:
  • 01C212
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 10, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istituto Auxologico Italiano
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2023