NCT05768581

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

February 20, 2023

Last Update Submit

August 19, 2025

Conditions

Keywords

physical activityobesity treatmentbody composition

Outcome Measures

Primary Outcomes (3)

  • Change from baseline strength in kilograms at 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

    Maximum aerobic capacity using the two minute step test

    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

    Up to 10 weeks

Secondary Outcomes (5)

  • Change from baseline fat mass percentage at 10 weeks

    Up to 10 weeks

  • Change from baseline weight in kilograms at 10 weeks

    Up to 10 weeks

  • Change from baseline height in meters at 10 weeks

    Up to 10 weeks

  • Change from baseline waist circumference in centimeters at 10 weeks

    Up to 10 weeks

  • Change from baseline circadian rhythm in arbitrary units at 10 weeks

    Up to 10 weeks

Study Arms (3)

Concurrent Training

EXPERIMENTAL

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

Other: Concurrent Training

Strength Training

EXPERIMENTAL

Experimental: home-based resistance training mode

Other: Strength Training

Aerobic Training

EXPERIMENTAL

Experimental: home-based endurance training mode

Other: Aerobic training

Interventions

Participants should perform strength training and aerobic exercises

Concurrent Training

Participants should perform strength exercises

Strength Training

Participants should perform aerobic exercises

Aerobic Training

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physical activity frequency minor of 2 days/week
  • BMI major of 30 kg/m2
  • informed consent signature

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

Location

Related Links

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 14, 2023

Study Start

October 1, 2022

Primary Completion

February 28, 2023

Study Completion

April 30, 2024

Last Updated

August 21, 2025

Record last verified: 2025-08

Locations