NCT04987255

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

July 21, 2021

Last Update Submit

April 26, 2023

Conditions

Sedentary BehaviorStroke

Keywords

Physical activityMuseumWell-beingSedentaryStroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Change from baseline (pre-visit): Postural control in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)

    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)

    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)

    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)

    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)

    75 minutes

  • +8 more secondary outcomes

Other Outcomes (2)

  • Cognitive status in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)

    baseline 60 minutes

  • Motor status in the three groups (free visit vs. guided visit and guided visit for individuals with stroke)

    baseline 60 minutes

Study Arms (3)

Free visit

ACTIVE COMPARATOR

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

Other: Free visit

Guided visit

EXPERIMENTAL

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

Other: Guided visit

Guided visit for individuals after stroke

OTHER

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

Other: Guided visit (stroke)

Interventions

Free visitOTHER

The persons with sedentary (healthy) in this group will have to visit the museum freely (without a guide) for a period of 75 minutes.

Free visit
Guided visitOTHER

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
Guided visit (stroke)OTHER

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.

Guided visit for individuals after stroke

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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...).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Musées de la ville de Genève

Geneva, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 24317382BACKGROUND

  • 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.

    PMID: 21798044BACKGROUND

  • 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.

    PMID: 31019480BACKGROUND

  • 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.

    PMID: 23308010BACKGROUND

MeSH Terms

Conditions

Sedentary BehaviorStrokeMotor Activity

Condition Hierarchy (Ancestors)

BehaviorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Anne-violette Bruyneel

    School of Health Sciences Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 21, 2021

First Posted

August 3, 2021

Study Start

November 15, 2021

Primary Completion

March 14, 2023

Study Completion

March 14, 2023

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measure will be made available.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available within 6 months of study completion
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.

Locations

CH(1)