ObesityCONCOBNCT05768581
Effects of Concurrent Training on Physical Fitness and Body Composition in Obese Individuals
A study testing Concurrent Training, Strength Training and Aerobic training in people with Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Concurrent Training, Strength Training and Aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physical activity frequency minor of 2 days/week
- BMI major of 30 kg/m2
- informed consent signature
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Concurrent Training, Strength Training, Aerobic training
- Keywords
- physical activity, obesity treatment, body composition
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent TrainingOther
Participants should perform strength training and aerobic exercises
Strength TrainingOther
Participants should perform strength exercises
Aerobic trainingOther
Participants should perform aerobic exercises
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Training | Experimental | Experimental: home-based concurrent training composed by strength and aerobic exercises within the same training session Receives: Other: Concurrent Training |
| Strength Training | Experimental | Experimental: home-based resistance training mode Receives: Other: Strength Training |
| Aerobic Training | Experimental | Experimental: home-based endurance training mode Receives: Other: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline strength in kilograms at 10 weeks
Maximum isometric handgrip strength using a dynamometer
Measured: Up to 10 weeks
Change from baseline cardiorespiratory fitness in number of steps performed at 10 weeks fitness
Maximum aerobic capacity using the two minute step test
Measured: Up to 10 weeks
Change from baseline postural control in arbitrary units at 10 weeks
Balance and postural control using the Balance Error Scoring System
Measured: Up to 10 weeks
Secondary outcomes (5)
Change from baseline fat mass percentage at 10 weeks
Fat mass % using a Tetrapolar Bioelectrical Impedance
Measured: Up to 10 weeks
Change from baseline weight in kilograms at 10 weeks
weight status using weight scale
Measured: Up to 10 weeks
Change from baseline height in meters at 10 weeks
height using a stadiometer
Measured: Up to 10 weeks
Change from baseline waist circumference in centimeters at 10 weeks
waist circumference using a 200 cm tape
Measured: Up to 10 weeks
Change from baseline circadian rhythm in arbitrary units at 10 weeks
Chronotype profile using Morningness-Eveningness Questionnaire
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Oct 2022
- Primary completion28 Feb 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768581
- Sponsor's protocol ID
- 43C202
- Acronym
- CONCOB
- Status last verified
- Aug 2025
- First submitted
- 20 Feb 2023
- Last updated
- 21 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Concurrent Home-based Training on Cardiorespiratory Fitness, Muscular Strength, Balance, Daily-life Activities and Body Composition in Obese Individuals
- ClinicalTrials.gov ID
- NCT05768581
- Acronym / sponsor ID
- CONCOB / 43C202
- Conditions
- Obesity
- Keywords
- physical activity, obesity treatment, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Concurrent Training | Experimental | Other: Concurrent TrainingExperimental: home-based concurrent training composed by strength and aerobic exercises within the same training session |
| Strength Training | Experimental | Other: Strength TrainingExperimental: home-based resistance training mode |
| Aerobic Training | Experimental | Other: Aerobic trainingExperimental: home-based endurance training mode |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Physical activity frequency minor of 2 days/week
- BMI major of 30 kg/m2
- informed consent signature
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concurrent TrainingParticipants should perform strength training and aerobic exercises | Other | Concurrent Training |
| Strength TrainingParticipants should perform strength exercises | Other | Strength Training |
| Aerobic trainingParticipants should perform aerobic exercises | Other | Aerobic Training |
Primary outcome
Change from baseline strength in kilograms at 10 weeks
Time frame: Up to 10 weeks
Maximum isometric handgrip strength using a dynamometer
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
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
5 secondary outcomes
Change from baseline fat mass percentage at 10 weeks
Time frame: Up to 10 weeks
Change from baseline weight in kilograms at 10 weeks
Time frame: Up to 10 weeks
Change from baseline height in meters at 10 weeks
Time frame: Up to 10 weeks
Change from baseline waist circumference in centimeters at 10 weeks
Time frame: Up to 10 weeks
Change from baseline circadian rhythm in arbitrary units at 10 weeks
Time frame: Up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent Training, Strength Training and Aerobic training in people with Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline strength in kilograms at 10 weeks (time frame: Up to 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.