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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • 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

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
Intervention / Treatment
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

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

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

Istituto Auxologico Italiano

Investigators

  • 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)

October 19, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Obesity

Clinical Trials on Movement quality

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe