- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04987255
The Art of Moving for Sustainable Health (ART-M2)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Virginie Cuvelier
- Email: virginie.cuvelier@hesge.ch
Study Locations
-
-
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Geneva, Switzerland
- Musées de la ville de Genève
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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...).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Free visit
Free visit of the museum during 75 minutes for individuals in sedentary condition (healthy)
|
The persons with sedentary (healthy) in this group will have to visit the museum freely (without a guide) for a period of 75 minutes.
|
Experimental: Guided visit
Guided visit of the museum during 75 minutes for individuals in sedentary condition (healthy)
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The 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 for individuals after stroke
This arm is specific for individuals with motor disability after stroke (non randomized condition)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
75 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
The standing balance will be tested in bipedal with forceplate.
Parameters: center of pressure displacement (mm).
|
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
|
The standing balance will be tested in bipedal with forceplate.
Parameters: center of pressure speed (mm/s).
|
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
|
The standing balance will be tested in bipedal with forceplate.
Parameters: center of pressure sway area (mm2).
|
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
|
The gait speed will be tested with the Ten-meter walking test.
Parameter: gait speed (m/s)
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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
|
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)
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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
|
The knee extensors muscle strength will be measured with an hand-held dynamometer.
Parameter: maximal voluntary force in Newton (N).
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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
|
The fatigue will be tested with the Numeric Rating Scale.
Parameter: 10-points score.
|
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
|
The pain will be tested with the Numeric Rating Scale.
Parameter: 10-points score.
|
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
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The anxiety will be tested with the Numeric Rating Scale.
Parameter: 10-points score.
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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
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The well-being will be tested with the museum well-being survey.
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75 minutes
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Safety endpoint 1: fatigue
Time Frame: 3 hours
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The fatigue will be tested with the Numeric Rating Scale.
Parameter: 10-points score.
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3 hours
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Safety endpoint 2: pain
Time Frame: 3 hours
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The fatigue will be tested with the Numeric Rating Scale.
Parameter: 10-points score.
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3 hours
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Safety endpoint 3: number of subjects
Time Frame: 3 hours
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The safety endpoint will be tested with the calculation of the number of subjects who completed the visit and the tests.
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3 hours
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive status in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Time Frame: baseline 60 minutes
|
The cognitive function will be tested with the Mini Mental State Evaluation.
Parameter: score / 28 points.
|
baseline 60 minutes
|
Motor status in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Time Frame: baseline 60 minutes
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The motor function will be tested with the Mini BESTest.
Parameter: score in percentage.
|
baseline 60 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Tudor-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.
- 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.
- Camic 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.
- Mastandrea 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 112187
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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