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

Primary Purpose

Obesity, Exercise Training

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Polarized workout program
High intensity workout program
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Obesity, Exercise training, Adolescents, Rehabilitation

Eligibility Criteria

13 Years - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Auxologico Italiano IRCCS, Site PiancavalloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Polarized workout

High intensity workout

Arm Description

Outcomes

Primary Outcome Measures

Peak VO2
Change in peak VO2

Secondary Outcome Measures

Body fat mass
Change in body fat mass - bioimpedance analysis
Body fat free mass
Change in body fat free mass - bioimpedance analysis
Body weight
Change in body weight
Body mass index
Change in body mass index

Full Information

First Posted
February 26, 2023
Last Updated
March 8, 2023
Sponsor
Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT05763394
Brief Title
Effects of Polarized Exercise in Adolescents With Severe Obesity (ALPOLAROB)
Acronym
ALPOLAROB
Official Title
Effects of Polarized Exercise on Cardiovascular Capacity and Lipid Metabolism in Adolescents With Severe Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Exercise Training
Keywords
Obesity, Exercise training, Adolescents, Rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polarized workout
Arm Type
Experimental
Arm Title
High intensity workout
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Polarized workout program
Intervention Description
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
Intervention Name(s)
High intensity workout program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peak VO2
Description
Change in peak VO2
Time Frame
Baseline and at the end of the rehabilitation program (21 days)
Secondary Outcome Measure Information:
Title
Body fat mass
Description
Change in body fat mass - bioimpedance analysis
Time Frame
Baseline and at the end of the rehabilitation program (21 days)
Title
Body fat free mass
Description
Change in body fat free mass - bioimpedance analysis
Time Frame
Baseline and at the end of the rehabilitation program (21 days)
Title
Body weight
Description
Change in body weight
Time Frame
Baseline and at the end of the rehabilitation program (21 days)
Title
Body mass index
Description
Change in body mass index
Time Frame
Baseline and at the end of the rehabilitation program (21 days)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Sartorio, MD
Phone
+390261911
Ext
2426
Email
sartorio@auxologico.it
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Grappiolo, Dr.
Phone
+390261911
Ext
2894
Email
luca.grappiolo@auxologico.it
Facility Information:
Facility Name
Istituto Auxologico Italiano IRCCS, Site Piancavallo
City
Oggebbio
State/Province
Verbania
ZIP/Postal Code
28824
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Sartorio, MD
Phone
+390261911
Ext
2426
Email
sartorio@auxologico.it

12. IPD Sharing Statement

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

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