Gender Impact on Physical Activity in Chronic Musculoskeletal Disorders Prevention (Move4Health)

March 4, 2025 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Gender Impact on Physical Activity in Chronic Musculoskeletal Disorders Prevention: a Survey-based Cross-sectional Study in Regione Lombardia

The goal of this survey based cross-sectional survey is to understand if there are gender patterns in physical activity participation and how they are associated with gendered organization of work and family activities, identifying socio-environmental variables that hamper the participation of both females and males in an active and healthy lifestyle. This survey also aim to explore if awareness and beliefs regarding musculoskeletal disorders and physical activity as factor for prevention differ according to gender and sex.

The main question is to investigate gender differences in physical activities participation in terms of adherence or not adherence to WHO recommendations by adjusting for socio-environmental variables.

The secondary questions are:

To explore impact of gender on health status and sedentary behavior at same adherence and intensity level of physical activity
To explore whether awareness and beliefs on musculoskeletal disorders and physical activity as prevention factor in the general population differ according to gender and sex.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Musculoskeletal disorders rank high in global disease burden, with women disproportionately affected. Physical inactivity, a key modifiable risk factor for chronic diseases, is more prevalent among women globally, influenced by social and environmental factors. Despite initiatives like the WHO's Global Action Plan on Physical Activity, gender disparities persist, necessitating targeted interventions to enhance equitable physical activity participation and address associated healthcare costs, as exemplified by Italy's recent prevention efforts.

The aim of the current study is to understand if there are gender patterns in physical activity participation and how they are associated with gendered organization of work and family activities, identifying socio-environmental variables that hamper the participation of both females and males in an active and healthy lifestyle.

The survey will be developed using SurveyMonkey® software, an online survey management software. Following approval from the Ethics Committee, the survey will be shared to adults residing in the Lombardy Region (Italy) through direct contacts or online channels (e.g., emails, social networks, online via a dedicated project webpage) using an ad hoc generated link. Formal informed consent will be collected online before starting the survey. Participation in the survey will be anonymous and voluntary with no payoff. After recruitment, data will be collected using Microsoft Excel and stored at the IRCCS Ospedale Galeazzi - Sant'Ambrogio, Milan, Italy.

The theoretical framework will be built drawing on similar questionnaires published in the literature and leaded by international recognized organizations assessing public physical activity participation and knowledge and perceptions towards chronic musculoskeletal disorders. Three experts will pilot the prefinal draft of the survey to assess face and content validity on the prefinal draft of the survey. Experts' feedback will be used to introduce minor amendments to the survey.

The final questionnaire version consisted of five sections:

(i) Characteristics of the respondent and socio-environmental context (ii) Work life balance (iii) Lifestyle habits and physical activity (iv) Knowledge and perception of chronic MSK disorders and physical activity as a preventive factor.

(v) The SF-12 questionnaire to assess health status of the participants.

The sample size calculation will be based on assumptions on primary and secondary outcomes, considering the most conservative value as sample size of interest.

Specifically:

Primary outcome: adherence to WHO recommendation Assuming an adherence to WHO recommendation (ie. Physical activity participation) among adult men of 40% and adult women of 30% (taken from ISTAT data of Lombardia Region), employing a 95% confidence, 80% power, the total sample size would be 712 adults. Only on this outcome we then considered different scenarios changing the expected percentage difference between men and women adherence to physical activity recommendation to 5% and 15%.
Secondary outcome: difference in health status between women and men at the same level of physical activity Assuming a difference in heath status between women and men of 1,3 on SF12 (women SF12 = mean 44.5 ± 7.4, men SF12= mean 43.2 ± 7.8), a variability of 7.5, employing a 95% confidence, 80% power, the total sample size would be 1048 adults.
Secondary outcome: difference in sedentary behavior between women and men at the same level of physical activity Assuming a difference in sedentary behavior between women and men of 0.94 hours per day (sedentary behavior man = 7.94 hours/day, sedentary behavior women = 8.89 hours/day), a variability of 2.13, employing a 95% confidence, 80% power, the total sample size would be 162 adults.

Overall, based on these calculations, 1048 adults will be needed as sample size that allow us to find a difference in adherence to physical activity of 10% between men and women but also guarantee a sufficient power for secondary outcomes.Taking into consideration non-responders and so an estimated response rate of 80% and a required sample size calculated in 1048 subjects, the number of individuals (out of the adult population residents in the Lombardy region of 6.371.890) needed to invite to participate at the survey to achieve the required sample size based on the expected response rate is 1310.

Study Type

Observational

Enrollment (Estimated)

1310

Contacts and Locations

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

Study Contact

Name: Silvia Bargeri
Phone Number: +39 02 8350 2260
Email: silvia.bargeri@grupposandonato.it

Study Locations

Italy
- - Milano, Italy, 20157
    - Recruiting
    - IRCCS Ospedale Galeazzi-Sant'Ambrogio
    - Contact:
      
      Silvia Bargeri
      
      Phone Number: +39 02 8350 2260
      
      Email: silvia.bargeri@grupposandonato.it
    - Contact:
      
      Silvia Bargeri
    - Contact:
      
      Stefania Guida

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

Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Residents in Region Lombardia and spoken/reader Italian language

Description

Inclusion Criteria:

Adults with age range between 18 and 64 years, residents in Region Lombardia and spoken/reader Italian language

Exclusion Criteria:

People with less than 18 years of age or more than 64 years of age. No other exclusion criteria will be applied.

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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Adults residents in Lombardia Region Adults with age ranging between 18 and 64 years, residents in Lombardia Region and spoken/reader Italian language

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to WHO recommendations on physical activity Time Frame: baseline (cross-sectional study)	Gender differences in the prevalence of adherents to WHO recommendations on physical activity assessed as a dichotomous variable (adherent or non-adherent), based on responses to the questions: "Can you quantify the amount of time you spend doing regular physical activity per week?" and "Can you quantify the usual intensity level (moderate/vigorous) of your physical activity per week?"	baseline (cross-sectional study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health status Time Frame: baseline (cross-sectional study)	Gender differences in mean health status measured with the 12-item Short Form Survey (SF-12) questionnaire. The SF-12 is a multi-purpose, generic measure of health status that allows for the construction of summary measures that assess the physical (PCS) and mental (MCS) health status of the participant. Scores are calculated using an algorithm. A score of 50 or higher indicates good health, while a score below 50 suggests poor health.	baseline (cross-sectional study)
Sedentary behavior Time Frame: baseline (cross-sectional study)	Gender differences in the prevalence of sedentary behavior assessed as a dichotomous variable (higher or lower than 6 sitting hours a day), based on responses to the question: "On a typical work or study day, how many hours do you spend sitting?"	baseline (cross-sectional study)

Collaborators and Investigators

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

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Collaborators

Ministry of Health, Italy

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.

General Publications

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)

February 24, 2025

Primary Completion (Estimated)

September 15, 2025

Study Completion (Estimated)

February 15, 2026

Study Registration Dates

First Submitted

December 18, 2024

First Submitted That Met QC Criteria