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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2023
Source School of Health Sciences Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

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...).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Free visit
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 visit
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)
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.

Locations

Country Name City State
Switzerland Musées de la ville de Genève Geneva

Sponsors (1)

Lead Sponsor Collaborator
School of Health Sciences Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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

Outcome

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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