Physical ActivityMove4HealthNCT06747052
Gender Impact On Physical Activity In Chronic Musculoskeletal Disorders Prevention
An observational study of Physical Activity and Musculoskeletal Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Musculoskeletal Disease, Gender Equity
- How many people
- 1,310 participants
- Where
- 1 siteItaly
- Study dates
- 24 Feb 2025to 15 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Residents in Region Lombardia and spoken/reader Italian language
Who may be able to join
- Adults with age range between 18 and 64 years, residents in Region Lombardia and spoken/reader Italian language
Who cannot join
- People with less than 18 years of age or more than 64 years of age. No other exclusion criteria will be applied.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Italy, 20157
Silvia Bargeri, +39 02 8350 2260, silvia.bargeri@grupposandonato.it
Silvia Bargeri
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Physical Activity, Musculoskeletal Disease, Gender Equity
- Keywords
- Physical activity, Gender, Musculoskeletal, Gender Equity, Surveys and Questionnaires, Cross-Sectional Studies
- Medical subject headings
- Motor Activity, Musculoskeletal Diseases, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Adherence to WHO recommendations on physical activity
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?"
Measured: baseline (cross-sectional study)
Secondary outcomes (2)
Health status
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.
Measured: baseline (cross-sectional study)
Sedentary behavior
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?"
Measured: baseline (cross-sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start24 Feb 2025
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747052
- Sponsor's protocol ID
- WeMoveForHealth
- Acronym
- Move4Health
- Status last verified
- Mar 2025
- First submitted
- 18 Dec 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cule M, Guliani H. Are there gender based differences in participation and time spent in physical activity in Albania? Evidence from 2017-18 demographic and health survey. Arch Public Health. 2022 Aug 11;80(1):187. doi: 10.1186/s13690-022-00930-2.
PubMed 35953833Eizagirre-Sagastibeltza O, Fernandez-Lasa U, Yanci J, Romaratezabala E, Cayero R, Iturrioz I, Usabiaga O. Design and Validation of a Questionnaire to Assess the Leisure Time Physical Activity of Adult Women in Gipuzkoa. Int J Environ Res Public Health. 2022 May 8;19(9):5736. doi: 10.3390/ijerph19095736.
PubMed 35565129Oliveira AJ, Lopes CS, Rostila M, Werneck GL, Griep RH, Leon AC, Faerstein E. Gender differences in social support and leisure-time physical activity. Rev Saude Publica. 2014 Aug;48(4):602-12. doi: 10.1590/s0034-8910.2014048005183.
PubMed 25210819Guthold R, Stevens GA, Riley LM, Bull FC. Worldwide trends in insufficient physical activity from 2001 to 2016: a pooled analysis of 358 population-based surveys with 1.9 million participants. Lancet Glob Health. 2018 Oct;6(10):e1077-e1086. doi: 10.1016/S2214-109X(18)30357-7. Epub 2018 Sep 4.
PubMed 30193830Ding D, Lawson KD, Kolbe-Alexander TL, Finkelstein EA, Katzmarzyk PT, van Mechelen W, Pratt M; Lancet Physical Activity Series 2 Executive Committee. The economic burden of physical inactivity: a global analysis of major non-communicable diseases. Lancet. 2016 Sep 24;388(10051):1311-24. doi: 10.1016/S0140-6736(16)30383-X. Epub 2016 Jul 28.
PubMed 27475266Liu S, Wang B, Fan S, Wang Y, Zhan Y, Ye D. Global burden of musculoskeletal disorders and attributable factors in 204 countries and territories: a secondary analysis of the Global Burden of Disease 2019 study. BMJ Open. 2022 Jun 29;12(6):e062183. doi: 10.1136/bmjopen-2022-062183.
PubMed 35768100
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Impact On Physical Activity In Chronic Musculoskeletal Disorders Prevention: A Survey-based Cross-sectional Study in Regione Lombardia
- ClinicalTrials.gov ID
- NCT06747052
- Acronym / sponsor ID
- Move4Health / WeMoveForHealth
- Conditions
- Physical Activity, Musculoskeletal Disease, Gender Equity
- Keywords
- Physical activity, Gender, Musculoskeletal, Gender Equity, Surveys and Questionnaires, Cross-Sectional Studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,310 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 24 Dec 2024 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults residents in Lombardia Region | – | –Adults with age ranging between 18 and 64 years, residents in Lombardia Region and spoken/reader Italian language |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents in Region Lombardia and spoken/reader Italian language
Key inclusion criteria (1 listed)
- Adults with age range between 18 and 64 years, residents in Region Lombardia and spoken/reader Italian language
Key exclusion criteria (1 listed)
- People with less than 18 years of age or more than 64 years of age. No other exclusion criteria will be applied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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?"
2 secondary outcomes
Health status
Time frame: baseline (cross-sectional study)
Sedentary behavior
Time frame: baseline (cross-sectional study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Results publication: PubMed 35953833Cule M, Guliani H. Are there gender based differences in participation and time spent in physical activity in Albania? Evidence from 2017-18 demographic and health survey. Arch Public Health. 2022 Aug 11;80(1):187. doi: 10.1186/s13690-022-00930-2.
- Results publication: PubMed 35565129Eizagirre-Sagastibeltza O, Fernandez-Lasa U, Yanci J, Romaratezabala E, Cayero R, Iturrioz I, Usabiaga O. Design and Validation of a Questionnaire to Assess the Leisure Time Physical Activity of Adult Women in Gipuzkoa. Int J Environ Res Public Health. 2022 May 8;19(9):5736. doi: 10.3390/ijerph19095736.
- Results publication: PubMed 25210819Oliveira AJ, Lopes CS, Rostila M, Werneck GL, Griep RH, Leon AC, Faerstein E. Gender differences in social support and leisure-time physical activity. Rev Saude Publica. 2014 Aug;48(4):602-12. doi: 10.1590/s0034-8910.2014048005183.
- Results publication: PubMed 30193830Guthold R, Stevens GA, Riley LM, Bull FC. Worldwide trends in insufficient physical activity from 2001 to 2016: a pooled analysis of 358 population-based surveys with 1.9 million participants. Lancet Glob Health. 2018 Oct;6(10):e1077-e1086. doi: 10.1016/S2214-109X(18)30357-7. Epub 2018 Sep 4.
- Results publication: PubMed 27475266Ding D, Lawson KD, Kolbe-Alexander TL, Finkelstein EA, Katzmarzyk PT, van Mechelen W, Pratt M; Lancet Physical Activity Series 2 Executive Committee. The economic burden of physical inactivity: a global analysis of major non-communicable diseases. Lancet. 2016 Sep 24;388(10051):1311-24. doi: 10.1016/S0140-6736(16)30383-X. Epub 2016 Jul 28.
- Results publication: PubMed 35768100Liu S, Wang B, Fan S, Wang Y, Zhan Y, Ye D. Global burden of musculoskeletal disorders and attributable factors in 204 countries and territories: a secondary analysis of the Global Burden of Disease 2019 study. BMJ Open. 2022 Jun 29;12(6):e062183. doi: 10.1136/bmjopen-2022-062183.
- WHO Physical activityLink provided by the sponsor.
- WHO More active people for a healthier world The global action plan on physical activity 2018 - 2030Link provided by the sponsor.
- Piano regionale di prevenzione 2021 - 2025 Regione LombardiaLink provided by the sponsor.
- CDC Questionnaires, Datasets, and Related DocumentationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity and Musculoskeletal Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Bargeri (+39 02 8350 2260, silvia.bargeri@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to WHO recommendations on physical activity (time frame: baseline (cross-sectional study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06747052, which also lists 6 linked publications.
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 5 Mar 2025.