Cultural Pathways to Develop Sustainable Health (ART'M2-APP)

May 14, 2024 updated by: Anne-Violette Bruyneel, School of Health Sciences Geneva

Assessment of Cultural Pathways in the City Developed on a Smartphone Application on Physical Abilities, Well-being and Sustainable Health Knowledge

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

64

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 Locations

      • Geneva, Switzerland
        • Geneva School of Health Sciences

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

Exclusion Criteria:

  • 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...).

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Free Museum visit
Free museum visit during 45 to 75 minutes
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.
Experimental: Cultural pathways App
Cultural pathways App during 45 to 75 minutes
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of steps during cultural activity in the 2 groups (free visit vs.cultural pathways)
Time Frame: 75 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline (pre-visit): fatigue in the 2 groups (free visit vs.cultural pathways)
Time Frame: 75 minutes
The fatigue will be tested with the Numeric Rating Scale. Parameter: 10-points score (1 = no fatigue, 10 = maximal fatigue).
75 minutes
Change from baseline (pre-visit): stress in the 2 groups (free visit vs.cultural pathways)
Time Frame: 75 minutes
The stress will be tested with the Numeric Rating Scale. Parameter: 10-points score (1 = no stress, 10 = maximal stress).
75 minutes
Change from baseline (pre-visit): pain in the 2 groups (free visit vs.cultural pathways)
Time Frame: 75 minutes
The pain will be tested with the Numeric Rating Scale. Parameter: 10-points score (1 = no pain, 10 = maximal pain).
75 minutes
Change from baseline (pre-visit): perceived balance in the 2 groups (free visit vs.cultural pathways)
Time Frame: 75 minutes
The perceived balance will be tested with a 5-points scale (1 = poor balance ; 5 = excellent balance)
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)
Time Frame: 75 minutes
The QSDFr will be tested with 8 questions. For each question a score from 0 to 2 will be given (0 = wrong answer, 1 = partial answer, 2 = right answer). The maximal score = 16 points and minimal = 0 points.
75 minutes
Change from baseline (pre-visit): Activities-Specific Balance Confidence (ABC-scale short version) (only intervention group)
Time Frame: 75 minutes
6-item self-report measure in which individuals rate their balance confidence for performing activities. Items are rated on a rating scale that ranges from 0 (no balance confidence) - 100 (complete balance confidence). Overall score is calculated by adding item scores and then dividing by the total number of items.
75 minutes
Change from baseline (pre-visit): Postural control (only intervention group) center of pressure displacement
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 (only intervention group) center of pressure velocity
Time Frame: 75 minutes
The standing balance will be tested in bipedal with forceplate. Parameters: center of pressure velocity (mm/s).
75 minutes
Change from baseline (pre-visit): Postural control (only intervention group) center of pressure sway area
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 and dual task (only intervention group)
Time Frame: 75 minutes
The gait speed will be tested with the Ten-meter walking test in normal walking, fast walking and in dual-task. Parameter: gait speed (m/s)
75 minutes
Change from baseline (pre-visit): museum well-being measures (only intervention group)
Time Frame: 75 minutes
The well-being will be tested with the museum well-being survey. A generic well-being questionnaire will be used with 12-item version. Each statement is rated out of five depending on the extent of agreement with it (1 = None of the time; 2 = Not very often; 3 = Some of the time; 4 = Very often; 5 = All of the time). The maximal score is 60 points (excellent well-being) and minimal score 12 points (poor well-being).
75 minutes
Change from baseline (pre-visit): museum well-being umbrella measures (only intervention group)
Time Frame: 75 minutes
The well-being will be tested with the museum well-being umbrella: positive well-being umbrella and negative well-being umbrella. Each of the six sections has a word next to it related to a well-being mood or emotion and numbers from one (I don't feel) to five (I feel extremely). Participants are required to rate the extent they feel the well-being word at that moment in time by circling the appropriate number, following the instructions provided. For both umbrella, maximal score = 30, minimal score = 6.
75 minutes
Safety endpoint: pain (Numeric Rating Scale)
Time Frame: 3 hours
The safety endpoint will be tested with the pain (Numeric Rating Scale). Parameter: 10-points score (1 = no pain, 10 = maximal pain).
3 hours
Safety endpoint: fatigue (Numeric Rating Scale)
Time Frame: 3 hours
The safety endpoint will be tested with the fatigue (Numeric Rating Scale). Parameter: 10-points score (1 = no fatigue, 10 = maximal fatigue).
3 hours
Safety endpoint: number of subjects who completed the cultural activity and tests.
Time Frame: 3 hours
The number of subjects who completed the cultural activity and tests will be reported.
3 hours

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Anne-Violette Bruyneel, Geneva School of Health Sciences

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 1, 2022

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • APP-112187

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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