ObesityFITOBNCT05773690
Home-based Training in Obese Individuals
A study testing Movement quality and Conventional Resistance Training in people with Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Movement quality and Conventional Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteItaly
- Study dates
- 19 Oct 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- physical activity frequency at least 1 days per week
- BMI index more than 30 kg/m2
- informed consent signature
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Movement quality, Conventional Resistance Training
- Keywords
- Obesity, Functional performance, Postural control, Muscular strength
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement qualityOther
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 TrainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Movement Quality group | Experimental | movement quality training based on mobility, stability and motor control exercises Receives: Other: Movement quality |
| Conventional resistance training group | Experimental | traditional strength training exercises Receives: Other: Conventional Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to six weeks
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
Measured: Up to six weeks
Change from baseline upper-body muscular strength at six weeks
Maximal isometric grip strength in kilograms using the handgrip dynamometer
Measured: Up to six weeks
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
Measured: Up to six weeks
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
Measured: Up to six weeks
Secondary outcomes (4)
Change from baseline weight at six weeks
Body weight using a calibrated weight scale in kilograms
Measured: Up to six weeks
Change from baseline height at six weeks
Body height using a calibrated stadiometer in meters
Measured: Up to six weeks
Change from baseline waist circumference at six weeks
Waist circumference using a 200 centimeters tape measure in centimeters
Measured: Up to six weeks
Change from baseline fat mass at six weeks
Fat mass percentage measurement using a bioelectric impedance analysis
Measured: Up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start19 Oct 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Cavaggioni, Principal investigator, Istituto Auxologico Italiano IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773690
- Sponsor's protocol ID
- 43C001
- Acronym
- FITOB
- Status last verified
- Apr 2025
- First submitted
- 22 Feb 2023
- Last updated
- 1 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Home-based Quality of Movement Protocol on Functional Movement, Postural Control and Muscular Strength in Obese Subjects
- ClinicalTrials.gov ID
- NCT05773690
- Acronym / sponsor ID
- FITOB / 43C001
- Conditions
- Obesity
- Keywords
- Obesity, Functional performance, Postural control, Muscular strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Movement Quality group | Experimental | Other: Movement qualitymovement quality training based on mobility, stability and motor control exercises |
| Conventional resistance training group | Experimental | Other: Conventional Resistance Trainingtraditional strength training exercises |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- physical activity frequency at least 1 days per week
- BMI index more than 30 kg/m2
- informed consent signature
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Movement quality6-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. | Other | Movement Quality group |
| Conventional Resistance Training6-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 | Other | Conventional resistance training group |
Primary outcome
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
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
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
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
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
4 secondary outcomes
Change from baseline weight at six weeks
Time frame: Up to six weeks
Change from baseline height at six weeks
Time frame: Up to six weeks
Change from baseline waist circumference at six weeks
Time frame: Up to six weeks
Change from baseline fat mass at six weeks
Time frame: Up to six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Cavaggioni principal investigator
Istituto Auxologico Italiano IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement quality and Conventional Resistance Training in people with Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline functional performance at six weeks (time frame: Up to six weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.