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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05773690
Other study ID # 43C001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2020
Est. completion date December 31, 2022

Study information

Verified date March 2023
Source Istituto Auxologico Italiano
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Generally, the enhancement of physical fitness depends on the optimal modulation of different physiological, technical or psychological stimuli and within the factors the would contribute to a decrease performance level, obesity is one of them. In this context, ample evidence shows that obesity is associated with an augmented cardio-metabolic risk, lowered postural control, functional performance and strength-related variables. International guidelines suggests to counteract obesity to respect a minimum dosage of 150 min a week of physical activity at moderate intensity performed with resistance training exercises with a frequency of 2-3 days/week. However, in the aforementioned guidelines there is a little consideration for what concern the quality of motor execution (i.e., "how" an individual performs each movement pattern). In addition, the available literature demonstrates the effectiveness of a "movement-quality" training intervention on fitness parameters and postural control, compared to a mere conventional exercise, in normal-weight individuals . In account to this, the purpose is to evaluate whether a quality of movement protocol would be more effective than a traditional strength training exercise in improving postural control and fitness parameters in subjects with obesity.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 60 Years
Eligibility Inclusion Criteria: - physical activity frequency at least 1 days per week - BMI index more than 30 kg/m2 - informed consent signature Exclusion Criteria: - aged more than 70 years - patients with knee pain (Visual Analogue Scale > 7 a.u.) - history of hip or knee replacement - severe hip or knee osteoarthrosis - cardiac or neurological condition contraindicating physical activity

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Movement quality
6-week-home-based training protocols designed to improve general fitness levels and postural control performed in a circuit-training mode (time of work per set 30 s, time of rest between each exercise 15 s, time of rest between sets 2 min, total volume 3 sets) for a duration of 45 min with a frequency of 3 days per week while performing mobility, stability and motor control exercises.
Conventional Resistance Training
6-week-home-based training protocols designed to improve general fitness levels and postural control performed in a circuit-training mode (time of work per set 30 s, time of rest between each exercise 15 s, time of rest between sets 2 min, total volume 3 sets) for a duration of 45 min with a frequency of 3 days per week while performing traditional strength training 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 functional performance at six weeks Functional performance using the Functional Movement Screen protocol in arbitrary units with a 0-12 point scale in which higher scores mean a better outcome Up to six weeks
Primary Change from baseline body balance at six weeks Body stability using the modified version of the Balance Error Scoring System protocol in arbitrary units with a 0-30 point scale in which lower scores mean a better outcome Up to six weeks
Primary Change from baseline upper-body muscular strength at six weeks Maximal isometric grip strength in kilograms using the handgrip dynamometer Up to six weeks
Primary Change from baseline lower-body muscular strength at six weeks Amount of time in seconds during a chair raise using the Five Repetition Sit-To-Stand protocol Up to six weeks
Primary Change from baseline breathing pattern at six weeks Breathing pattern performance using the Total Faulty Breathing Scale protocol in arbitrary units with a 0-12 point scale in which lower scores mean a better outcome Up to six weeks
Secondary Change from baseline weight at six weeks Body weight using a calibrated weight scale in kilograms Up to six weeks
Secondary Change from baseline height at six weeks Body height using a calibrated stadiometer in meters Up to six weeks
Secondary Change from baseline waist circumference at six weeks Waist circumference using a 200 centimeters tape measure in centimeters Up to six weeks
Secondary Change from baseline fat mass at six weeks Fat mass percentage measurement using a bioelectric impedance analysis Up to six weeks
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