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The Art of Moving for Sustainable Health (ART-M2)

Primary Purpose

Sedentary Behavior, Stroke

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Free visit
Guided visit
Guided visit (stroke)
Sponsored by
School of Health Sciences Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sedentary Behavior focused on measuring Physical activity, Museum, Well-being, Sedentary, Stroke

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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...).

Sites / Locations

  • Musées de la ville de Genève

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

Free visit

Guided visit

Guided visit for individuals after stroke

Arm Description

Free visit of the museum during 75 minutes for individuals in sedentary condition (healthy)

Guided visit of the museum during 75 minutes for individuals in sedentary condition (healthy)

This arm is specific for individuals with motor disability after stroke (non randomized condition)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).
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)
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)
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).
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.
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.
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.
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.
Safety endpoint 1: fatigue
The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score.
Safety endpoint 2: pain
The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score.
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.

Full Information

First Posted
July 21, 2021
Last Updated
April 26, 2023
Sponsor
School of Health Sciences Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT04987255
Brief Title
The Art of Moving for Sustainable Health
Acronym
ART-M2
Official Title
The Art of Moving for Sustainable Health: Influence of a Museum Visit on the Physical Demands and Well-being of Sedentary People
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
March 14, 2023 (Actual)
Study Completion Date
March 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
School of Health Sciences Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Behavior, Stroke
Keywords
Physical activity, Museum, Well-being, Sedentary, Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Free visit
Arm Type
Active Comparator
Arm Description
Free visit of the museum during 75 minutes for individuals in sedentary condition (healthy)
Arm Title
Guided visit
Arm Type
Experimental
Arm Description
Guided visit of the museum during 75 minutes for individuals in sedentary condition (healthy)
Arm Title
Guided visit for individuals after stroke
Arm Type
Other
Arm Description
This arm is specific for individuals with motor disability after stroke (non randomized condition)
Intervention Type
Other
Intervention Name(s)
Free visit
Intervention Description
The persons with sedentary (healthy) in this group will have to visit the museum freely (without a guide) for a period of 75 minutes.
Intervention Type
Other
Intervention Name(s)
Guided visit
Intervention Description
The persons with sedentary (healthy) in this group will have to visit the museum with a guide for a period of 75 minutes.
Intervention Type
Other
Intervention Name(s)
Guided visit (stroke)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of steps during visit in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Description
An activity tracker on the visitor's wrist will measure the number of steps taken while visiting the museum. Parameter: number of steps.
Time Frame
75 minutes
Secondary Outcome Measure Information:
Title
Change from baseline (pre-visit): Postural control in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Description
The standing balance will be tested in bipedal with forceplate. Parameters: center of pressure displacement (mm).
Time Frame
75 minutes
Title
Change from baseline (pre-visit): Postural control in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Description
The standing balance will be tested in bipedal with forceplate. Parameters: center of pressure speed (mm/s).
Time Frame
75 minutes
Title
Change from baseline (pre-visit): Postural control in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Description
The standing balance will be tested in bipedal with forceplate. Parameters: center of pressure sway area (mm2).
Time Frame
75 minutes
Title
Change from baseline (pre-visit): gait speed in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Description
The gait speed will be tested with the Ten-meter walking test. Parameter: gait speed (m/s)
Time Frame
75 minutes
Title
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)
Description
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)
Time Frame
75 minutes
Title
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)
Description
The knee extensors muscle strength will be measured with an hand-held dynamometer. Parameter: maximal voluntary force in Newton (N).
Time Frame
75 minutes
Title
Change from baseline (pre-visit): fatigue in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Description
The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score.
Time Frame
75 minutes
Title
Change from baseline (pre-visit): pain in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Description
The pain will be tested with the Numeric Rating Scale. Parameter: 10-points score.
Time Frame
75 minutes
Title
Change from baseline (pre-visit): anxiety in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Description
The anxiety will be tested with the Numeric Rating Scale. Parameter: 10-points score.
Time Frame
75 minutes
Title
Change from baseline (pre-visit): museum well-being in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Description
The well-being will be tested with the museum well-being survey.
Time Frame
75 minutes
Title
Safety endpoint 1: fatigue
Description
The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score.
Time Frame
3 hours
Title
Safety endpoint 2: pain
Description
The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score.
Time Frame
3 hours
Title
Safety endpoint 3: number of subjects
Description
The safety endpoint will be tested with the calculation of the number of subjects who completed the visit and the tests.
Time Frame
3 hours
Other Pre-specified Outcome Measures:
Title
Cognitive status in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Description
The cognitive function will be tested with the Mini Mental State Evaluation. Parameter: score / 28 points.
Time Frame
baseline 60 minutes
Title
Motor status in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)
Description
The motor function will be tested with the Mini BESTest. Parameter: score in percentage.
Time Frame
baseline 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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...).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-violette Bruyneel
Organizational Affiliation
School of Health Sciences Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Musées de la ville de Genève
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measure will be made available.
IPD Sharing Time Frame
Data will be available within 6 months of study completion
IPD Sharing Access Criteria
At the end of the project the data will be deposited in the Yareta repository developed by the University of Geneva OR in an institutional repository. This choice will ensure that data is archived and shared in accordance with FAIR principles.
Citations:
PubMed Identifier
24317382
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.
Results Reference
background
PubMed Identifier
21798044
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.
Results Reference
background
PubMed Identifier
31019480
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.
Results Reference
background
PubMed Identifier
23308010
Citation
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.
Results Reference
background

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The Art of Moving for Sustainable Health

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