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Effects of Concurrent Training on Physical Fitness and Body Composition in Obese Individuals (CONCOB)

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Concurrent Training
Strength Training
Aerobic training
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring physical activity, obesity treatment, body composition

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Physical activity frequency minor of 2 days/week BMI major of 30 kg/m2 informed consent signature Exclusion Criteria: age over 65 years knee or hip pain (visual analogue scale score >7 arbitrary units a history of hip, knee or foot replacement or osteoarthrosis cardiac infarction neurological impairments or any other clinical condition that affects the practice of physical activity

Sites / Locations

  • Istituto Auxologico Italiano IRCCSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Concurrent Training

Strength Training

Aerobic Training

Arm Description

Experimental: home-based concurrent training composed by strength and aerobic exercises within the same training session

Experimental: home-based resistance training mode

Experimental: home-based endurance training mode

Outcomes

Primary Outcome Measures

Change from baseline strength in kilograms at 10 weeks
Maximum isometric handgrip strength using a dynamometer
Change from baseline cardiorespiratory fitness in number of steps performed at 10 weeks fitness
Maximum aerobic capacity using the two minute step test
Change from baseline postural control in arbitrary units at 10 weeks
Balance and postural control using the Balance Error Scoring System

Secondary Outcome Measures

Change from baseline fat mass percentage at 10 weeks
Fat mass % using a Tetrapolar Bioelectrical Impedance
Change from baseline weight in kilograms at 10 weeks
weight status using weight scale
Change from baseline height in meters at 10 weeks
height using a stadiometer
Change from baseline waist circumference in centimeters at 10 weeks
waist circumference using a 200 cm tape
Change from baseline circadian rhythm in arbitrary units at 10 weeks
Chronotype profile using Morningness-Eveningness Questionnaire

Full Information

First Posted
February 20, 2023
Last Updated
March 3, 2023
Sponsor
Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT05768581
Brief Title
Effects of Concurrent Training on Physical Fitness and Body Composition in Obese Individuals
Acronym
CONCOB
Official Title
Effects of a Concurrent Home-based Training on Cardiorespiratory Fitness, Muscular Strength, Balance, Daily-life Activities and Body Composition in Obese Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (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
Ample evidence demonstrates the beneficial role of physical activity combined with a structured dietary plan to counteract obesity. International guidelines as the World Health Organization states that to improve fitness levels at least 150 min a week of physical activity at moderate intensity, combined with resistance training composed of 8-12 repetitions with an intensity of 60-70%1RM for each muscle group, are recommended. In this regard, a minimum dosage of 60-90 min of physical activity composed by aerobic exercises in alternation with resistance training protocols, allow a sequential development of cardiorespiratory fitness and muscular strength parameters avoiding potential interference effects. Interference may occur when strength and endurance stimuli both target opposite peripheral adaptations (e.g., hypertrophy vs. muscle capillarization) and this phenomenon seems to be particularly clear during adolescence. Nevertheless, the incorporation of different training stimuli within the same training session is called Concurrent Training. This training mode, thanks to the activation of two different metabolic pathways (e.g., aerobic and anaerobic), has a variety, beneficial effects in terms of muscle mass and strength development, body composition profile regulation and neuromotor function improvement. Concurrent Training seems to be effective not only in normal-weight subjects, but also in obese individuals, reporting positive adaptations on physical fitness and health status compared with a single-mode (i.e., aerobic or strength training). Therefore, the aim of this study is to detect the effects of a 10-week-Concurrent Training protocol compared with a single training modality on physical fitness, body composition and circadian rhythms in adult outpatients with obesity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
physical activity, obesity treatment, body composition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concurrent Training
Arm Type
Experimental
Arm Description
Experimental: home-based concurrent training composed by strength and aerobic exercises within the same training session
Arm Title
Strength Training
Arm Type
Experimental
Arm Description
Experimental: home-based resistance training mode
Arm Title
Aerobic Training
Arm Type
Experimental
Arm Description
Experimental: home-based endurance training mode
Intervention Type
Other
Intervention Name(s)
Concurrent Training
Intervention Description
Participants should perform strength training and aerobic exercises
Intervention Type
Other
Intervention Name(s)
Strength Training
Intervention Description
Participants should perform strength exercises
Intervention Type
Other
Intervention Name(s)
Aerobic training
Intervention Description
Participants should perform aerobic exercises
Primary Outcome Measure Information:
Title
Change from baseline strength in kilograms at 10 weeks
Description
Maximum isometric handgrip strength using a dynamometer
Time Frame
Up to 10 weeks
Title
Change from baseline cardiorespiratory fitness in number of steps performed at 10 weeks fitness
Description
Maximum aerobic capacity using the two minute step test
Time Frame
Up to 10 weeks
Title
Change from baseline postural control in arbitrary units at 10 weeks
Description
Balance and postural control using the Balance Error Scoring System
Time Frame
Up to 10 weeks
Secondary Outcome Measure Information:
Title
Change from baseline fat mass percentage at 10 weeks
Description
Fat mass % using a Tetrapolar Bioelectrical Impedance
Time Frame
Up to 10 weeks
Title
Change from baseline weight in kilograms at 10 weeks
Description
weight status using weight scale
Time Frame
Up to 10 weeks
Title
Change from baseline height in meters at 10 weeks
Description
height using a stadiometer
Time Frame
Up to 10 weeks
Title
Change from baseline waist circumference in centimeters at 10 weeks
Description
waist circumference using a 200 cm tape
Time Frame
Up to 10 weeks
Title
Change from baseline circadian rhythm in arbitrary units at 10 weeks
Description
Chronotype profile using Morningness-Eveningness Questionnaire
Time Frame
Up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Physical activity frequency minor of 2 days/week BMI major of 30 kg/m2 informed consent signature Exclusion Criteria: age over 65 years knee or hip pain (visual analogue scale score >7 arbitrary units a history of hip, knee or foot replacement or osteoarthrosis cardiac infarction neurological impairments or any other clinical condition that affects the practice of physical activity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Cavaggioni
Phone
+3902619111
Email
cavaggioni.luca@gmail.com
Facility Information:
Facility Name
Istituto Auxologico Italiano IRCCS
City
Milan
ZIP/Postal Code
20145
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Cavaggioni

12. IPD Sharing Statement

Links:
URL
https://pubmed.ncbi.nlm.nih.gov/23703517/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/33239350/
Description
Related Info
URL
https://link.springer.com/chapter/10.1007/978-3-319-75547-2_27
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/30131714/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/7193134/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/35669575/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/27986760/
Description
Related Info

Learn more about this trial

Effects of Concurrent Training on Physical Fitness and Body Composition in Obese Individuals

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