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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05768581
Other study ID # 43C202
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date April 30, 2024

Study information

Verified date March 2023
Source Istituto Auxologico Italiano
Contact Luca Cavaggioni
Phone +3902619111
Email cavaggioni.luca@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Istituto Auxologico Italiano IRCCS Milan

Sponsors (1)

Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline strength in kilograms at 10 weeks Maximum isometric handgrip strength using a dynamometer Up to 10 weeks
Primary 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
Primary 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 Change from baseline fat mass percentage at 10 weeks Fat mass % using a Tetrapolar Bioelectrical Impedance Up to 10 weeks
Secondary Change from baseline weight in kilograms at 10 weeks weight status using weight scale Up to 10 weeks
Secondary Change from baseline height in meters at 10 weeks height using a stadiometer Up to 10 weeks
Secondary Change from baseline waist circumference in centimeters at 10 weeks waist circumference using a 200 cm tape Up to 10 weeks
Secondary Change from baseline circadian rhythm in arbitrary units at 10 weeks Chronotype profile using Morningness-Eveningness Questionnaire Up to 10 weeks
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