Stroke Clinical Trial
— ART-M2Official title:
The Art of Moving for Sustainable Health: Influence of a Museum Visit on the Physical Demands and Well-being of Sedentary People
NCT number | NCT04987255 |
Other study ID # | 112187 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 15, 2021 |
Est. completion date | March 14, 2023 |
Verified date | April 2023 |
Source | School of Health Sciences Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | March 14, 2023 |
Est. primary completion date | March 14, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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...). |
Country | Name | City | State |
---|---|---|---|
Switzerland | Musées de la ville de Genève | Geneva |
Lead Sponsor | Collaborator |
---|---|
School of Health Sciences Geneva |
Switzerland,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cognitive status in the three groups (free visit vs. guided visit and guided visit for individuals with stroke) | The cognitive function will be tested with the Mini Mental State Evaluation. Parameter: score / 28 points. | baseline 60 minutes | |
Other | Motor status in the three groups (free visit vs. guided visit and guided visit for individuals with stroke) | The motor function will be tested with the Mini BESTest. Parameter: score in percentage. | baseline 60 minutes | |
Primary | 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. | 75 minutes | |
Secondary | 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). | 75 minutes | |
Secondary | 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). | 75 minutes | |
Secondary | 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). | 75 minutes | |
Secondary | 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) | 75 minutes | |
Secondary | 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) | 75 minutes | |
Secondary | 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). | 75 minutes | |
Secondary | 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. | 75 minutes | |
Secondary | 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. | 75 minutes | |
Secondary | 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. | 75 minutes | |
Secondary | 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. | 75 minutes | |
Secondary | Safety endpoint 1: fatigue | The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score. | 3 hours | |
Secondary | Safety endpoint 2: pain | The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score. | 3 hours | |
Secondary | 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. | 3 hours |
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