Home-based Training in Obese Individuals (FITOB)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Movement quality
Conventional Resistance Training
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Functional performance, Postural control, Muscular strength
Eligibility Criteria
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
Sites / Locations
- Istituto Auxologico Italiano IRCCS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Movement Quality group
Conventional resistance training group
Arm Description
movement quality training based on mobility, stability and motor control exercises
traditional strength training exercises
Outcomes
Primary Outcome Measures
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
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
Change from baseline upper-body muscular strength at six weeks
Maximal isometric grip strength in kilograms using the handgrip dynamometer
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
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
Secondary Outcome Measures
Change from baseline weight at six weeks
Body weight using a calibrated weight scale in kilograms
Change from baseline height at six weeks
Body height using a calibrated stadiometer in meters
Change from baseline waist circumference at six weeks
Waist circumference using a 200 centimeters tape measure in centimeters
Change from baseline fat mass at six weeks
Fat mass percentage measurement using a bioelectric impedance analysis
Full Information
NCT ID
NCT05773690
First Posted
February 22, 2023
Last Updated
March 6, 2023
Sponsor
Istituto Auxologico Italiano
1. Study Identification
Unique Protocol Identification Number
NCT05773690
Brief Title
Home-based Training in Obese Individuals
Acronym
FITOB
Official Title
Effects of a Home-based Quality of Movement Protocol on Functional Movement, Postural Control and Muscular Strength in Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Functional performance, Postural control, Muscular strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Movement Quality group
Arm Type
Experimental
Arm Description
movement quality training based on mobility, stability and motor control exercises
Arm Title
Conventional resistance training group
Arm Type
Experimental
Arm Description
traditional strength training exercises
Intervention Type
Other
Intervention Name(s)
Movement quality
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Resistance Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline functional performance at six weeks
Description
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
Time Frame
Up to six weeks
Title
Change from baseline body balance at six weeks
Description
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
Time Frame
Up to six weeks
Title
Change from baseline upper-body muscular strength at six weeks
Description
Maximal isometric grip strength in kilograms using the handgrip dynamometer
Time Frame
Up to six weeks
Title
Change from baseline lower-body muscular strength at six weeks
Description
Amount of time in seconds during a chair raise using the Five Repetition Sit-To-Stand protocol
Time Frame
Up to six weeks
Title
Change from baseline breathing pattern at six weeks
Description
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
Time Frame
Up to six weeks
Secondary Outcome Measure Information:
Title
Change from baseline weight at six weeks
Description
Body weight using a calibrated weight scale in kilograms
Time Frame
Up to six weeks
Title
Change from baseline height at six weeks
Description
Body height using a calibrated stadiometer in meters
Time Frame
Up to six weeks
Title
Change from baseline waist circumference at six weeks
Description
Waist circumference using a 200 centimeters tape measure in centimeters
Time Frame
Up to six weeks
Title
Change from baseline fat mass at six weeks
Description
Fat mass percentage measurement using a bioelectric impedance analysis
Time Frame
Up to six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Cavaggioni
Organizational Affiliation
Istituto Auxologico Italiano IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Auxologico Italiano IRCCS
City
Milan
ZIP/Postal Code
20145
Country
Italy
12. IPD Sharing Statement
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/26594181/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/15181027/
Description
Related Info
URL
http://dx.doi.org/10.1016/S0140-6736(05)67483-1
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/26667010/
Description
Related Info
URL
https://link.springer.com/article/10.1007/s13679-012-0018-7
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/30326791/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/11740312/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/25763518/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/30040032/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/31500505/
Description
Related Info
Learn more about this trial
Home-based Training in Obese Individuals
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