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

April 26, 2023 updated by: Anne-Violette Bruynnel, School of Health Sciences Geneva

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

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Geneva, Switzerland
        • Musées de la ville de Genève

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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)
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)
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).
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
The anxiety will be tested with the Numeric Rating Scale. Parameter: 10-points score.
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
The well-being will be tested with the museum well-being survey.
75 minutes
Safety endpoint 1: fatigue
Time Frame: 3 hours
The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score.
3 hours
Safety endpoint 2: pain
Time Frame: 3 hours
The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score.
3 hours
Safety endpoint 3: number of subjects
Time Frame: 3 hours
The safety endpoint will be tested with the calculation of the number of subjects who completed the visit and the tests.
3 hours

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
The motor function will be tested with the Mini BESTest. Parameter: score in percentage.
baseline 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

March 14, 2023

Study Completion (Actual)

March 14, 2023

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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