NCT05635695

Brief Summary

The 2030 Agenda for Sustainable Development, adopted by all United Nations Member States in 2015 includes the goal 3 "Ensure healthy lives and promote well-being for all at all ages". One of the essential axes is to promote primary prevention in order to avoid the emergence of diseases and the treatments use with a high environmental impact. Physical activity (PA) is a means of primary prevention known to be very effective in the fight against chronic diseases. Despite the recommendations on PA, a high number of people are sedentary and in particular in older persons. The main barriers are accessibility and lack of motivation for traditional PA. The investigators believe that the development of cultural pathways could be an excellent way to improve people's health. The objective of this study is to assess the effects of cultural pathways on the physical abilities, well-being and sustainable health knowledge of sedentary people over 50 years old. This intervention will be compared to a control group visiting a museum freely. The hypothesis is that cultural pathways including games induce enough steps to be considered an effective activity to fight sedentary lifestyle. The number of steps should be higher than the control group. Fatigue, stress and well-being should be improved after the visit as well as sustainable health knowledge. 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 intervention or control. The number of steps taken during the cultural activity will be measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

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

Study Start

First participant enrolled

November 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

November 14, 2022

Last Update Submit

May 14, 2024

Conditions

Sedentary Behavior

Keywords

Sustainable healthPhysical ActivityCultural pathwaysAppSedentary

Outcome Measures

Primary Outcomes (1)

  • Number of steps during cultural activity in the 2 groups (free visit vs.cultural pathways)

    An activity tracker on the visitor's wrist will measure the number of steps taken while visiting the museum free or with app. Parameter: number of steps.

    75 minutes

Secondary Outcomes (15)

  • Change from baseline (pre-visit): fatigue in the 2 groups (free visit vs.cultural pathways)

    75 minutes

  • Change from baseline (pre-visit): stress in the 2 groups (free visit vs.cultural pathways)

    75 minutes

  • Change from baseline (pre-visit): pain in the 2 groups (free visit vs.cultural pathways)

    75 minutes

  • Change from baseline (pre-visit): perceived balance in the 2 groups (free visit vs.cultural pathways)

    75 minutes

  • Change from baseline (pre-visit): survey about "sustainable health knowledge" (questionnaire en santé durable in french - QSDFr) in the 2 groups (free visit vs.cultural pathways)

    75 minutes

  • +10 more secondary outcomes

Study Arms (2)

Free Museum visit

ACTIVE COMPARATOR

Free museum visit during 45 to 75 minutes

Other: Free Museum visit

Cultural pathways App

EXPERIMENTAL

Cultural pathways App during 45 to 75 minutes

Other: Cultural pathways App

Interventions

Free Museum visitOTHER

People are tested when they arrive at the museum. Then, they freely visit the different rooms for 45 to 75 minutes. No instructions are given.

Free Museum visit
Cultural pathways AppOTHER

Cultural pathways in the park of the museum will be proposed to people with a smartphone application that will give directions, cultural and sustainable health contents, points of interest with games and specific information about the pathways (distance, noise level, walkability, practical information). There will be two possible levels: contemplative or active.

Cultural pathways App

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
  • Walking independently with or without assistance
  • Ability to understand the instructions

You may not qualify if:

  • Refusal to participate;
  • Person with other conditions affecting independent walking;
  • Contraindications to prolonged standing;
  • 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)

Geneva School of Health Sciences

Geneva, Switzerland

Location

Related Publications (3)

  • 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

  • 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 BehaviorMotor ActivityAlzheimer Disease

Condition Hierarchy (Ancestors)

BehaviorDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Anne-Violette Bruyneel

    Geneva School of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON 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

November 14, 2022

First Posted

December 2, 2022

Study Start

November 1, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

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)