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

Sponsor
Istituto Auxologico Italiano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05768581
Collaborator
(none)
130
1
3
19
6.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Concurrent Training
  • Other: Strength Training
  • Other: Aerobic training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effects of a Concurrent Home-based Training on Cardiorespiratory Fitness, Muscular Strength, Balance, Daily-life Activities and Body Composition in Obese Individuals
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Concurrent Training

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

Other: Concurrent Training
Participants should perform strength training and aerobic exercises

Experimental: Strength Training

Experimental: home-based resistance training mode

Other: Strength Training
Participants should perform strength exercises

Experimental: Aerobic Training

Experimental: home-based endurance training mode

Other: Aerobic training
Participants should perform aerobic exercises

Outcome Measures

Primary Outcome Measures

  1. Change from baseline strength in kilograms at 10 weeks [Up to 10 weeks]

    Maximum isometric handgrip strength using a dynamometer

  2. Change from baseline cardiorespiratory fitness in number of steps performed at 10 weeks fitness [Up to 10 weeks]

    Maximum aerobic capacity using the two minute step test

  3. Change from baseline postural control in arbitrary units at 10 weeks [Up to 10 weeks]

    Balance and postural control using the Balance Error Scoring System

Secondary Outcome Measures

  1. Change from baseline fat mass percentage at 10 weeks [Up to 10 weeks]

    Fat mass % using a Tetrapolar Bioelectrical Impedance

  2. Change from baseline weight in kilograms at 10 weeks [Up to 10 weeks]

    weight status using weight scale

  3. Change from baseline height in meters at 10 weeks [Up to 10 weeks]

    height using a stadiometer

  4. Change from baseline waist circumference in centimeters at 10 weeks [Up to 10 weeks]

    waist circumference using a 200 cm tape

  5. Change from baseline circadian rhythm in arbitrary units at 10 weeks [Up to 10 weeks]

    Chronotype profile using Morningness-Eveningness Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istituto Auxologico Italiano IRCCS Milan Italy 20145

Sponsors and Collaborators

  • Istituto Auxologico Italiano

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT05768581
Other Study ID Numbers:
  • 43C202
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istituto Auxologico Italiano
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2023