Sedentary BehaviorART-M2NCT04987255
The Art of Moving for Sustainable Health
A study testing Free visit, Guided visit and Guided visit (stroke) in people with Sedentary Behavior and Stroke, run by School of Health Sciences Geneva at 1 site in Switzerland.
Trial summary
Sedentary behaviour is particularly high among the older and in the presence of a chronic pathology. Physical activity is limited mainly by the lack of accessibility to activities offered in the city and the lack of motivation. 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, Stroke
- What is being tested?
- Free visit, Guided visit and Guided visit (stroke)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Nov 2021to 14 Mar 2023
- 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
- Mini Mental State Evauation > 22
- Walking independently with or without assistance
- MiniBESTest > 20/28
- For individuals with stroke: chronic post-stroke condition.
Who cannot join
- Refusal to participate;
- Person with other conditions affecting independent walking;
- Contraindications to prolonged standing;
- Pain greater than 4/10 on the NRS;
- 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: The Art of Moving for Sustainable Health: Influence of a Museum Visit on the Physical Demands and Well-being of Sedentary People
Sedentary behaviour is particularly high among the older and in the presence of a chronic pathology. Physical activity is limited mainly by the lack of accessibility to activities offered in the city and the lack of motivation.
The objective is to study the physical solicitations and the well-being during the visit of a museum (free or guided visit). Our hypothesis is that this cultural activity induces a sufficient physical solicitation for sedentary people and for individuals with a post-stroke motor disability.
Read more
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 visits. The number of steps taken during the visit will be measured.
This is a different approach to promote physical activity and this proposal is an original way to stimulate the physical, psychic and social health of sedentary people. If the results are beneficial, museums could become real health partners to stimulate the activity of sedentary people.
- Conditions
- Sedentary Behavior, Stroke
- Being tested
- Free visit, Guided visit, Guided visit (stroke)
- Keywords
- Physical activity, Museum, Well-being, Sedentary, Stroke
- Medical subject headings
- Sedentary Behavior, Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free visitOther
The persons with sedentary (healthy) in this group will have to visit the museum freely (without a guide) for a period of 75 minutes.
Guided visitOther
The persons with sedentary (healthy) in this group will have to visit the museum with a guide for a period of 75 minutes.
Guided visit (stroke)Other
The persons with motor disability after stroke in this group will have to visit the museum with a guide for a period of 75 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Free visit | Active comparator | Free visit of the museum during 75 minutes for individuals in sedentary condition (healthy) Receives: Other: Free visit |
| Guided visit | Experimental | Guided visit of the museum during 75 minutes for individuals in sedentary condition (healthy) Receives: Other: Guided visit |
| Guided visit for individuals after stroke | Other | This arm is specific for individuals with motor disability after stroke (non randomized condition) Receives: Other: Guided visit (stroke) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps during visit in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
An activity tracker on the visitor's wrist will measure the number of steps taken while visiting the museum. Parameter: number of steps.
Measured: 75 minutes
Secondary outcomes (13)
Change from baseline (pre-visit): Postural control in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
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 in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
The standing balance will be tested in bipedal with forceplate. Parameters: center of pressure speed (mm/s).
Measured: 75 minutes
Change from baseline (pre-visit): Postural control in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
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 in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
The gait speed will be tested with the Ten-meter walking test. Parameter: gait speed (m/s)
Measured: 75 minutes
Change from baseline (pre-visit): sit to stand transfert in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
The sit to stand transfert will be tested with the five sit to stand test. Parameter: duration to realize five sit-to stand transferts (seconds)
Measured: 75 minutes
Change from baseline (pre-visit): lower limb muscle strength in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
The knee extensors muscle strength will be measured with an hand-held dynamometer. Parameter: maximal voluntary force in Newton (N).
Measured: 75 minutes
Change from baseline (pre-visit): fatigue in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score.
Measured: 75 minutes
Change from baseline (pre-visit): pain in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
The pain will be tested with the Numeric Rating Scale. Parameter: 10-points score.
Measured: 75 minutes
Change from baseline (pre-visit): anxiety in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
The anxiety will be tested with the Numeric Rating Scale. Parameter: 10-points score.
Measured: 75 minutes
Change from baseline (pre-visit): museum well-being in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
The well-being will be tested with the museum well-being survey.
Measured: 75 minutes
Safety endpoint 1: fatigue
The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score.
Measured: 3 hours
Safety endpoint 2: pain
The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score.
Measured: 3 hours
Safety endpoint 3: number of subjects
The safety endpoint will be tested with the calculation of the number of subjects who completed the visit and the tests.
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 posted3 Aug 2021
- Study start15 Nov 2021
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- School of Health Sciences Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Violette Bruynnel, School of Health Sciences Geneva
- Investigators
- Anne-violette Bruyneel, Principal investigator, School of Health Sciences Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987255
- Sponsor's protocol ID
- 112187
- Acronym
- ART-M2
- Status last verified
- Apr 2023
- First submitted
- 21 Jul 2021
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21798044Mastandrea S, Fagioli S, Biasi V. Art and Psychological Well-Being: Linking the Brain to the Aesthetic Emotion. Front Psychol. 2019 Apr 4;10:739. doi: 10.3389/fpsyg.2019.00739. eCollection 2019.
PubMed 31019480Camic 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 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Art of Moving for Sustainable Health: Influence of a Museum Visit on the Physical Demands and Well-being of Sedentary People
- ClinicalTrials.gov ID
- NCT04987255
- Acronym / sponsor ID
- ART-M2 / 112187
- Conditions
- Sedentary Behavior, Stroke
- Keywords
- Physical activity, Museum, Well-being, Sedentary, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- School of Health Sciences GenevaUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 3 Aug 2021 (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.
Sedentary behaviour is particularly high among the older and in the presence of a chronic pathology. Physical activity is limited mainly by the lack of accessibility to activities offered in the city and the lack of motivation.
The objective is to study the physical solicitations and the well-being during the visit of a museum (free or guided visit). Our hypothesis is that this cultural activity induces a sufficient physical solicitation for sedentary people and for individuals with a post-stroke motor disability.
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 visits. The number of steps taken during the visit will be measured.
This is a different approach to promote physical activity and this proposal is an original way to stimulate the physical, psychic and social health of sedentary people. If the results are beneficial, museums could become real health partners to stimulate the activity of sedentary people.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Free visit | Active comparator | Other: Free visitFree visit of the museum during 75 minutes for individuals in sedentary condition (healthy) |
| Guided visit | Experimental | Other: Guided visitGuided visit of the museum during 75 minutes for individuals in sedentary condition (healthy) |
| Guided visit for individuals after stroke | Other | Other: Guided visit (stroke)This arm is specific for individuals with motor disability after stroke (non randomized condition) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 50 years
- Sedentary condition (<150 minutes of physical activity per week)
- Medical stability
- Mini Mental State Evauation > 22
- Walking independently with or without assistance
Key exclusion criteria (6 listed)
- Refusal to participate;
- Person with other conditions affecting independent walking;
- Contraindications to prolonged standing;
- Pain greater than 4/10 on the NRS;
- Concomitant pathologies that may interfere with the results;
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 visitThe persons with sedentary (healthy) in this group will have to visit the museum freely (without a guide) for a period of 75 minutes. | Other | Free visit |
| Guided visitThe persons with sedentary (healthy) in this group will have to visit the museum with a guide for a period of 75 minutes. | Other | Guided visit |
| Guided visit (stroke)The persons with motor disability after stroke in this group will have to visit the museum with a guide for a period of 75 minutes. | Other | Guided visit for individuals after stroke |
Primary outcome
Number of steps during visit in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Time frame: 75 minutes
An activity tracker on the visitor's wrist will measure the number of steps taken while visiting the museum. Parameter: number of steps.
13 secondary outcomes
Change from baseline (pre-visit): Postural control in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Time frame: 75 minutes
Change from baseline (pre-visit): Postural control in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Time frame: 75 minutes
Change from baseline (pre-visit): Postural control in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Time frame: 75 minutes
Change from baseline (pre-visit): gait speed in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Time frame: 75 minutes
Change from baseline (pre-visit): sit to stand transfert in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Time frame: 75 minutes
Change from baseline (pre-visit): lower limb muscle strength in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Time frame: 75 minutes
Change from baseline (pre-visit): fatigue in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Time frame: 75 minutes
Change from baseline (pre-visit): pain in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Time frame: 75 minutes
Change from baseline (pre-visit): anxiety in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Time frame: 75 minutes
Change from baseline (pre-visit): museum well-being in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Time frame: 75 minutes
Safety endpoint 1: fatigue
Time frame: 3 hours
Safety endpoint 2: pain
Time frame: 3 hours
Safety endpoint 3: number of subjects
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 27 Apr 2023.
- 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 31019480Mastandrea S, Fagioli S, Biasi V. Art and Psychological Well-Being: Linking the Brain to the Aesthetic Emotion. Front Psychol. 2019 Apr 4;10:739. doi: 10.3389/fpsyg.2019.00739. eCollection 2019.
- 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
School of Health Sciences Geneva
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 visit, Guided visit and Guided visit (stroke) in people with Sedentary Behavior and Stroke, 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 7 inclusion and 6 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 27 Apr 2023. 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 visit in the three groups (free visit vs. guided visit and guided visit for individuals with stroke) (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 NCT04987255, which also lists 4 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 27 Apr 2023.