Sedentary BehaviorART'M2-APPNCT05635695
Cultural Pathways to Develop Sustainable Health
A study testing Free Museum visit and Cultural pathways App in people with Sedentary Behavior, run by School of Health Sciences Geneva at 1 site in Switzerland.
Trial summary
The 2030 Agenda for Sustainable Development, adopted by all United Nations Member States in 2015 includes the goal 3 "Ensure healthy lives and promote well-being for all at all ages". Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Free Museum visit and Cultural pathways App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2022to 1 Feb 2024
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 50 years
- Sedentary condition (<150 minutes of physical activity per week)
- Medical stability
- Walking independently with or without assistance
- Ability to understand the instructions
Who cannot join
- Refusal to participate;
- Person with other conditions affecting independent walking;
- Contraindications to prolonged standing;
- Concomitant pathologies that may interfere with the results;
- Inability to follow the study procedure (cognitive disorders, dementia, psychological disorders, language problems...).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Cultural Pathways in the City Developed on a Smartphone Application on Physical Abilities, Well-being and Sustainable Health Knowledge
The 2030 Agenda for Sustainable Development, adopted by all United Nations Member States in 2015 includes the goal 3 "Ensure healthy lives and promote well-being for all at all ages". One of the essential axes is to promote primary prevention in order to avoid the emergence of diseases and the treatments use with a high environmental impact. Physical activity (PA) is a means of primary prevention known to be very effective in the fight against chronic diseases.
Despite the recommendations on PA, a high number of people are sedentary and in particular in older persons. The main barriers are accessibility and lack of motivation for traditional PA. The investigators believe that the development of cultural pathways could be an excellent way to improve people's health.
Read more
The objective of this study is to assess the effects of cultural pathways on the physical abilities, well-being and sustainable health knowledge of sedentary people over 50 years old. This intervention will be compared to a control group visiting a museum freely. The hypothesis is that cultural pathways including games induce enough steps to be considered an effective activity to fight sedentary lifestyle. The number of steps should be higher than the control group. Fatigue, stress and well-being should be improved after the visit as well as sustainable health knowledge.
All the tests will be carried out during the same day by experienced physiotherapists. Physical and well-being tests will be performed before and after the intervention or control. The number of steps taken during the cultural activity will be measured.
- Conditions
- Sedentary Behavior
- Being tested
- Free Museum visit, Cultural pathways App
- Keywords
- Sustainable health, Physical Activity, Cultural pathways, App, Sedentary
- Medical subject headings
- Sedentary Behavior, Motor Activity, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Museum visitOther
People are tested when they arrive at the museum. Then, they freely visit the different rooms for 45 to 75 minutes. No instructions are given.
Cultural pathways AppOther
Cultural pathways in the park of the museum will be proposed to people with a smartphone application that will give directions, cultural and sustainable health contents, points of interest with games and specific information about the pathways (distance, noise level, walkability, practical information). There will be two possible levels: contemplative or active.
| Study group | Role | What they receive |
|---|---|---|
| Free Museum visit | Active comparator | Free museum visit during 45 to 75 minutes Receives: Other: Free Museum visit |
| Cultural pathways App | Experimental | Cultural pathways App during 45 to 75 minutes Receives: Other: Cultural pathways App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps during cultural activity in the 2 groups (free visit vs.cultural pathways)
An activity tracker on the visitor's wrist will measure the number of steps taken while visiting the museum free or with app. Parameter: number of steps.
Measured: 75 minutes
Secondary outcomes (15)
Change from baseline (pre-visit): fatigue in the 2 groups (free visit vs.cultural pathways)
The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score (1 = no fatigue, 10 = maximal fatigue).
Measured: 75 minutes
Change from baseline (pre-visit): stress in the 2 groups (free visit vs.cultural pathways)
The stress will be tested with the Numeric Rating Scale. Parameter: 10-points score (1 = no stress, 10 = maximal stress).
Measured: 75 minutes
Change from baseline (pre-visit): pain in the 2 groups (free visit vs.cultural pathways)
The pain will be tested with the Numeric Rating Scale. Parameter: 10-points score (1 = no pain, 10 = maximal pain).
Measured: 75 minutes
Change from baseline (pre-visit): perceived balance in the 2 groups (free visit vs.cultural pathways)
The perceived balance will be tested with a 5-points scale (1 = poor balance ; 5 = excellent balance)
Measured: 75 minutes
Change from baseline (pre-visit): survey about "sustainable health knowledge" (questionnaire en santé durable in french - QSDFr) in the 2 groups (free visit vs.cultural pathways)
The QSDFr will be tested with 8 questions. For each question a score from 0 to 2 will be given (0 = wrong answer, 1 = partial answer, 2 = right answer). The maximal score = 16 points and minimal = 0 points.
Measured: 75 minutes
Change from baseline (pre-visit): Activities-Specific Balance Confidence (ABC-scale short version) (only intervention group)
6-item self-report measure in which individuals rate their balance confidence for performing activities. Items are rated on a rating scale that ranges from 0 (no balance confidence) - 100 (complete balance confidence). Overall score is calculated by adding item scores and then dividing by the total number of items.
Measured: 75 minutes
Change from baseline (pre-visit): Postural control (only intervention group) center of pressure displacement
The standing balance will be tested in bipedal with forceplate. Parameters: center of pressure displacement (mm).
Measured: 75 minutes
Change from baseline (pre-visit): Postural control (only intervention group) center of pressure velocity
The standing balance will be tested in bipedal with forceplate. Parameters: center of pressure velocity (mm/s).
Measured: 75 minutes
Change from baseline (pre-visit): Postural control (only intervention group) center of pressure sway area
The standing balance will be tested in bipedal with forceplate. Parameters: center of pressure sway area (mm2).
Measured: 75 minutes
Change from baseline (pre-visit): gait speed and dual task (only intervention group)
The gait speed will be tested with the Ten-meter walking test in normal walking, fast walking and in dual-task. Parameter: gait speed (m/s)
Measured: 75 minutes
Change from baseline (pre-visit): museum well-being measures (only intervention group)
The well-being will be tested with the museum well-being survey. A generic well-being questionnaire will be used with 12-item version. Each statement is rated out of five depending on the extent of agreement with it (1 = None of the time; 2 = Not very often; 3 = Some of the time; 4 = Very often; 5 = All of the time). The maximal score is 60 points (excellent well-being) and minimal score 12 points (poor well-being).
Measured: 75 minutes
Change from baseline (pre-visit): museum well-being umbrella measures (only intervention group)
The well-being will be tested with the museum well-being umbrella: positive well-being umbrella and negative well-being umbrella. Each of the six sections has a word next to it related to a well-being mood or emotion and numbers from one (I don't feel) to five (I feel extremely). Participants are required to rate the extent they feel the well-being word at that moment in time by circling the appropriate number, following the instructions provided. For both umbrella, maximal score = 30, minimal score = 6.
Measured: 75 minutes
Safety endpoint: pain (Numeric Rating Scale)
The safety endpoint will be tested with the pain (Numeric Rating Scale). Parameter: 10-points score (1 = no pain, 10 = maximal pain).
Measured: 3 hours
Safety endpoint: fatigue (Numeric Rating Scale)
The safety endpoint will be tested with the fatigue (Numeric Rating Scale). Parameter: 10-points score (1 = no fatigue, 10 = maximal fatigue).
Measured: 3 hours
Safety endpoint: number of subjects who completed the cultural activity and tests.
The number of subjects who completed the cultural activity and tests will be reported.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Nov 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- School of Health Sciences Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Violette Bruyneel, School of Health Sciences Geneva
- Investigators
- Anne-Violette Bruyneel, Principal investigator, Geneva School of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635695
- Sponsor's protocol ID
- APP-112187
- Acronym
- ART'M2-APP
- Status last verified
- May 2024
- First submitted
- 14 Nov 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measure will be made available.
Publications
Harvey JA, Chastin SF, Skelton DA. Prevalence of sedentary behavior in older adults: a systematic review. Int J Environ Res Public Health. 2013 Dec 2;10(12):6645-61. doi: 10.3390/ijerph10126645.
PubMed 24317382Tudor-Locke C, Craig CL, Aoyagi Y, Bell RC, Croteau KA, De Bourdeaudhuij I, Ewald B, Gardner AW, Hatano Y, Lutes LD, Matsudo SM, Ramirez-Marrero FA, Rogers LQ, Rowe DA, Schmidt MD, Tully MA, Blair SN. How many steps/day are enough? For older adults and special populations. Int J Behav Nutr Phys Act. 2011 Jul 28;8:80. doi: 10.1186/1479-5868-8-80.
PubMed 21798044Camic PM, Chatterjee HJ. Museums and art galleries as partners for public health interventions. Perspect Public Health. 2013 Jan;133(1):66-71. doi: 10.1177/1757913912468523.
PubMed 23308010
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cultural Pathways in the City Developed on a Smartphone Application on Physical Abilities, Well-being and Sustainable Health Knowledge
- ClinicalTrials.gov ID
- NCT05635695
- Acronym / sponsor ID
- ART'M2-APP / APP-112187
- Conditions
- Sedentary Behavior
- Keywords
- Sustainable health, Physical Activity, Cultural pathways, App, Sedentary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- School of Health Sciences GenevaUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 2 Dec 2022 (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 2030 Agenda for Sustainable Development, adopted by all United Nations Member States in 2015 includes the goal 3 "Ensure healthy lives and promote well-being for all at all ages". One of the essential axes is to promote primary prevention in order to avoid the emergence of diseases and the treatments use with a high environmental impact. Physical activity (PA) is a means of primary prevention known to be very effective in the fight against chronic diseases.
Despite the recommendations on PA, a high number of people are sedentary and in particular in older persons. The main barriers are accessibility and lack of motivation for traditional PA. The investigators believe that the development of cultural pathways could be an excellent way to improve people's health.
The objective of this study is to assess the effects of cultural pathways on the physical abilities, well-being and sustainable health knowledge of sedentary people over 50 years old. This intervention will be compared to a control group visiting a museum freely. The hypothesis is that cultural pathways including games induce enough steps to be considered an effective activity to fight sedentary lifestyle. The number of steps should be higher than the control group. Fatigue, stress and well-being should be improved after the visit as well as sustainable health knowledge.
All the tests will be carried out during the same day by experienced physiotherapists. Physical and well-being tests will be performed before and after the intervention or control. The number of steps taken during the cultural activity will be measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free Museum visit | Active comparator | Other: Free Museum visitFree museum visit during 45 to 75 minutes |
| Cultural pathways App | Experimental | Other: Cultural pathways AppCultural pathways App during 45 to 75 minutes |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 50 years
- Sedentary condition (<150 minutes of physical activity per week)
- Medical stability
- Walking independently with or without assistance
- Ability to understand the instructions
Key exclusion criteria (5 listed)
- Refusal to participate;
- Person with other conditions affecting independent walking;
- Contraindications to prolonged standing;
- Concomitant pathologies that may interfere with the results;
- Inability to follow the study procedure (cognitive disorders, dementia, psychological disorders, language problems...).
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 |
|---|---|---|
| Free Museum visitPeople are tested when they arrive at the museum. Then, they freely visit the different rooms for 45 to 75 minutes. No instructions are given. | Other | Free Museum visit |
| Cultural pathways AppCultural pathways in the park of the museum will be proposed to people with a smartphone application that will give directions, cultural and sustainable health contents, points of interest with games and specific information about the pathways (distance, noise level, walkability, practical information). There will be two possible levels: contemplative or active. | Other | Cultural pathways App |
Primary outcome
Number of steps during cultural activity in the 2 groups (free visit vs.cultural pathways)
Time frame: 75 minutes
An activity tracker on the visitor's wrist will measure the number of steps taken while visiting the museum free or with app. Parameter: number of steps.
15 secondary outcomes
Change from baseline (pre-visit): fatigue in the 2 groups (free visit vs.cultural pathways)
Time frame: 75 minutes
Change from baseline (pre-visit): stress in the 2 groups (free visit vs.cultural pathways)
Time frame: 75 minutes
Change from baseline (pre-visit): pain in the 2 groups (free visit vs.cultural pathways)
Time frame: 75 minutes
Change from baseline (pre-visit): perceived balance in the 2 groups (free visit vs.cultural pathways)
Time frame: 75 minutes
Change from baseline (pre-visit): survey about "sustainable health knowledge" (questionnaire en santé durable in french - QSDFr) in the 2 groups (free visit vs.cultural pathways)
Time frame: 75 minutes
Change from baseline (pre-visit): Activities-Specific Balance Confidence (ABC-scale short version) (only intervention group)
Time frame: 75 minutes
Change from baseline (pre-visit): Postural control (only intervention group) center of pressure displacement
Time frame: 75 minutes
Change from baseline (pre-visit): Postural control (only intervention group) center of pressure velocity
Time frame: 75 minutes
Change from baseline (pre-visit): Postural control (only intervention group) center of pressure sway area
Time frame: 75 minutes
Change from baseline (pre-visit): gait speed and dual task (only intervention group)
Time frame: 75 minutes
Change from baseline (pre-visit): museum well-being measures (only intervention group)
Time frame: 75 minutes
Change from baseline (pre-visit): museum well-being umbrella measures (only intervention group)
Time frame: 75 minutes
Safety endpoint: pain (Numeric Rating Scale)
Time frame: 3 hours
Safety endpoint: fatigue (Numeric Rating Scale)
Time frame: 3 hours
Safety endpoint: number of subjects who completed the cultural activity and tests.
Time frame: 3 hours
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 16 May 2024.
- Background: PubMed 24317382Harvey JA, Chastin SF, Skelton DA. Prevalence of sedentary behavior in older adults: a systematic review. Int J Environ Res Public Health. 2013 Dec 2;10(12):6645-61. doi: 10.3390/ijerph10126645.
- Background: PubMed 21798044Tudor-Locke C, Craig CL, Aoyagi Y, Bell RC, Croteau KA, De Bourdeaudhuij I, Ewald B, Gardner AW, Hatano Y, Lutes LD, Matsudo SM, Ramirez-Marrero FA, Rogers LQ, Rowe DA, Schmidt MD, Tully MA, Blair SN. How many steps/day are enough? For older adults and special populations. Int J Behav Nutr Phys Act. 2011 Jul 28;8:80. doi: 10.1186/1479-5868-8-80.
- Background: PubMed 23308010Camic PM, Chatterjee HJ. Museums and art galleries as partners for public health interventions. Perspect Public Health. 2013 Jan;133(1):66-71. doi: 10.1177/1757913912468523.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measure will be made available.
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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.
Anne-Violette Bruyneel principal investigator
Geneva School of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Museum visit and Cultural pathways App in people with Sedentary Behavior, run by School of Health Sciences Geneva at 1 site in Switzerland.
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 5 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 16 May 2024. 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 Switzerland. 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?
Number of steps during cultural activity in the 2 groups (free visit vs.cultural pathways) (time frame: 75 minutes). 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 NCT05635695, which also lists 3 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 16 May 2024.