Investigating the Effects of a Museum Intervention on the Psychological and Cardiac Health of Older Adults

Aging Clinical Trial

— HeART-BRAIN  

Official title:

HeART-BRAIN : Investigating the Effects of a Museum Intervention on the Psychological and Cardiac Health of Older Adults With and Without Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06130358
• Other study ID #: ICM 2024-3325
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: November 2023
• Source: Montreal Heart Institute
• Contact: Emma G Dupuy, PhD
• Phone: 514-374-1480
• Email: emma.dupuy[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In a recent report, the World Organization for Health provided some evidence that artistic and cultural activities can support the health and well-being of the population. Our previous research suggests that the effect of museum visits on well-being and stress might be tied to relaxing proprieties of contact with art objects, especially when the artwork is viewed with an introspective and self-reflexive approach. This study addresses the effect of a well-being museum intervention of six weeks on cerebral activity associated with artwork contemplation during a museum visit and assesses how it affects the psychological and cardiovascular health of older adults with and without atrial fibrillation. The well-being intervention will engage the participant in a series of 6 visits, in groups of 10, oriented on his feelings, impressions, and interpretations of artworks. This well-being museum intervention will be compared to visits typically provided in the museum, in a cross-over single-blinded design.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Men/women aged 50 and over,
• Presenting normal or corrected vision and hearing,
• With or without controlled Atrial fibrillation,
• No specific expertise in visual arts (official degree or training relating to the visual arts),
• Occasionally attended museums and exhibitions (= 6 times per year).

Exclusion Criteria:

• Score > 5/15 on the geriatric depression scale,
• Score on the telephone version of the MMSE < 19,
• Psychiatric or neurological diagnosis,
• Presence of major functional limitations likely to affect the individual's ability to stand and walk independently.

Related Conditions & MeSH terms

• Aging
• Atrial Fibrillation
• Atrial Fibrillation Recurrent

Intervention

Other:
• Experimental: Well-being intervention followed by classic intervention
2 x 6 weeks of weekly museum visits
• Experimental: Classic intervention followed by well-being intervention
2 x 6 weeks of weekly museum visits

Locations

Country	Name	City	State
Canada	Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute	Montréal	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Louis Bherer	Fonds de la Recherche en Santé du Québec, Mitacs, Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Heart rate	bpm	Before and after the 6 weeks of interventions
Other	Change in arterial pressure	mmHg	Before and after the 6 weeks of interventions
Other	Change in salivary cortisol concentration	microg/l	Before and after the 6 weeks of interventions
Other	Change in emotionnal regulation	Difficulties in Emotion Regulation Scale DERS-F scale (Score ranges from 36-180, with a higher score indicating more emotion regulation problems)	Before and after the 6 weeks of interventions
Other	Change in perceived stress	Perceived Stress Scale questionnaire (Score ranges from 0-4, with 0 no stress,1 mild stress, 3 moderate stress and 4 severe).	Before and after the 6 weeks of interventions
Other	Change in Depressive symptomatology	Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology).	Before and after the 6 weeks of interventions
Other	Change in Quality-of-life	36-Item Short Form Health Survey (Scale ranges from 0-100, with a higher score indicating a better health status).	Before and after the 6 weeks of interventions
Other	Change in Perceived social support	Lubben Social Network Scale questionnaire (Score ranges from 0-30, with a higher score indicating more social engagement).	Before and after the 6 weeks of interventions
Other	Change in Repetitive negative thinking	Perseverative thinking questionnaire (Score ranges from 0-60, with a higher score indicating more repetitive negative thinking).	Before and after the 6 weeks of interventions
Other	Change in perceived fatigue	Fatigue Severity Scale (Score ranges from 9-63, with a higher score more fatigue)	Before and after the 6 weeks of interventions
Other	Change in global cognition	MoCA total score (Score ranges from 0-30, with a higher score indicating better performance)	Before and after the 6 weeks of interventions
Other	Change in executive functioning	Computerized Stroop task, Reaction time (ms)	Before and after the 6 weeks of interventions
Other	Self-reported masculinity and femininity trait	Short Form Bem Sex-Role Inventory questionnaire (30 items questionnaire with 10 items assessing the femininity traits, 10 items assessing the masculinity traits, and 10 items neutral, not scored. Two scores are calculated for femininity and masculinity, respectively, and range from 10-70, whit a higher score indicating a higher femininity or masculinity trait).	Baseline
Other	Cognitive Reserve	Rami and colleagues' cognitive reserve questionnaire (Scale ranges from 0-26, with a higher score indicating a greater cognitive reserve).	Baseline
Primary	Change in the activity evoked within the ventrolateral prefrontal cortex during the contemplation of artwork	Hemodynamic variations in the region of interest (concentration of oxygenated hemoglobin [HbO2], no units).	Before and after the 6 weeks of interventions
Secondary	Change in the activity evoked within the medial prefrontal cortex during the contemplation of artwork	Hemodynamic variations in the region of interest (concentration of oxygenated hemoglobin [HbO2], no units).	Before and after the 6 weeks of interventions