NCT05773690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

February 22, 2023

Last Update Submit

April 29, 2025

Conditions

Keywords

ObesityFunctional performancePostural controlMuscular strength

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • Change from baseline upper-body muscular strength at 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

    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

    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 Outcomes (4)

  • Change from baseline weight at six weeks

    Up to six weeks

  • Change from baseline height at six weeks

    Up to six weeks

  • Change from baseline waist circumference at six weeks

    Up to six weeks

  • Change from baseline fat mass at six weeks

    Up to six weeks

Study Arms (2)

Movement Quality group

EXPERIMENTAL

movement quality training based on mobility, stability and motor control exercises

Other: Movement quality

Conventional resistance training group

EXPERIMENTAL

traditional strength training exercises

Other: Conventional Resistance Training

Interventions

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.

Movement Quality group

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

Conventional resistance training group

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • physical activity frequency at least 1 days per week
  • BMI index more than 30 kg/m2
  • informed consent signature

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

Location

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luca Cavaggioni

    Istituto Auxologico Italiano IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 17, 2023

Study Start

October 19, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations