Home-based Training in Obese Individuals (FITOB)

April 29, 2025 updated by: Istituto Auxologico Italiano

Effects of a Home-based Quality of Movement Protocol on Functional Movement, Postural Control and Muscular Strength in Obese Subjects

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20145
        • Istituto Auxologico Italiano IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Movement Quality group
movement quality training based on mobility, stability and motor control exercises
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.
Experimental: Conventional resistance training group
traditional strength training exercises
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline functional performance at six weeks
Time Frame: Up to 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
Change from baseline body balance at six weeks
Time Frame: Up to 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
Change from baseline upper-body muscular strength at six weeks
Time Frame: Up to six weeks
Maximal isometric grip strength in kilograms using the handgrip dynamometer
Up to six weeks
Change from baseline lower-body muscular strength at six weeks
Time Frame: Up to six weeks
Amount of time in seconds during a chair raise using the Five Repetition Sit-To-Stand protocol
Up to six weeks
Change from baseline breathing pattern at six weeks
Time Frame: Up to 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline weight at six weeks
Time Frame: Up to six weeks
Body weight using a calibrated weight scale in kilograms
Up to six weeks
Change from baseline height at six weeks
Time Frame: Up to six weeks
Body height using a calibrated stadiometer in meters
Up to six weeks
Change from baseline waist circumference at six weeks
Time Frame: Up to six weeks
Waist circumference using a 200 centimeters tape measure in centimeters
Up to six weeks
Change from baseline fat mass at six weeks
Time Frame: Up to six weeks
Fat mass percentage measurement using a bioelectric impedance analysis
Up to six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Auxologico Italiano

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luca Cavaggioni, Istituto Auxologico Italiano IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 43C001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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