- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05768581
Effects of Concurrent Training on Physical Fitness and Body Composition in Obese Individuals (CONCOB)
August 19, 2025 updated by: Istituto Auxologico Italiano
Effects of a Concurrent Home-based Training on Cardiorespiratory Fitness, Muscular Strength, Balance, Daily-life Activities and Body Composition in Obese Individuals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Milan, Italy, 20145
- Istituto Auxologico Italiano IRCCS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Concurrent Training
Experimental: home-based concurrent training composed by strength and aerobic exercises within the same training session
|
Participants should perform strength training and aerobic exercises
|
|
Experimental: Strength Training
Experimental: home-based resistance training mode
|
Participants should perform strength exercises
|
|
Experimental: Aerobic Training
Experimental: home-based endurance training mode
|
Participants should perform aerobic exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline strength in kilograms at 10 weeks
Time Frame: Up to 10 weeks
|
Maximum isometric handgrip strength using a dynamometer
|
Up to 10 weeks
|
|
Change from baseline cardiorespiratory fitness in number of steps performed at 10 weeks fitness
Time Frame: Up to 10 weeks
|
Maximum aerobic capacity using the two minute step test
|
Up to 10 weeks
|
|
Change from baseline postural control in arbitrary units at 10 weeks
Time Frame: Up to 10 weeks
|
Balance and postural control using the Balance Error Scoring System
|
Up to 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline fat mass percentage at 10 weeks
Time Frame: Up to 10 weeks
|
Fat mass % using a Tetrapolar Bioelectrical Impedance
|
Up to 10 weeks
|
|
Change from baseline weight in kilograms at 10 weeks
Time Frame: Up to 10 weeks
|
weight status using weight scale
|
Up to 10 weeks
|
|
Change from baseline height in meters at 10 weeks
Time Frame: Up to 10 weeks
|
height using a stadiometer
|
Up to 10 weeks
|
|
Change from baseline waist circumference in centimeters at 10 weeks
Time Frame: Up to 10 weeks
|
waist circumference using a 200 cm tape
|
Up to 10 weeks
|
|
Change from baseline circadian rhythm in arbitrary units at 10 weeks
Time Frame: Up to 10 weeks
|
Chronotype profile using Morningness-Eveningness Questionnaire
|
Up to 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2022
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
April 30, 2024
Study Registration Dates
First Submitted
February 20, 2023
First Submitted That Met QC Criteria
March 3, 2023
First Posted (Actual)
March 14, 2023
Study Record Updates
Last Update Posted (Actual)
August 21, 2025
Last Update Submitted That Met QC Criteria
August 19, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43C202
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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