- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07305389
The MUSICare Project: Effects of Differentiated Music Exposure on Exercise-Related Affect Among Cardiac Rehabilitation Inpatients (MUSICare)
Affective phenomena, such as core affect, remembered pleasure, or forecasted pleasure, play a key role in promoting physical activity (PA) behaviour, especially among inpatients. The use of music has been shown to be a particularly cost-effective and low-friction approach to promoting positive affective valence during PA. However, interventions using music to improve exercise-related affective phenomena among inpatients are lacking. This study will aim to investigate an intervention that combines the effects of music with the "peak-end rule" on core affective responses (valence and arousal), remembered pleasure, and forecasted pleasure associated with exercise sessions among cardiac rehabilitation inpatients.
The primary objective of the present study will be to examine the effect of differentiated music exposure on core affective responses, ratings of perceived exertion and psychophysiological responses to moderate-intensity continuous training (MICT), as well as on associated remembered pleasure, exercise enjoyment, and forecasted pleasure. A secondary objective will be to assess the potential mediating effect of affective valence at the end of the MICT on remembered pleasure and exercise enjoyment. A third objective will be to assess the effect of MICT with or without music on an emotional rating task, together with pupillometric measures. Finally, the study will examine the influence of remembered pleasure on subsequent forecasted pleasure.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elena Tessitore, MD
- Phone Number: +41795532615
- Email: elena.tessitore@hcuge.ch
Study Locations
-
-
-
Geneva, Switzerland, 1205
- Recruiting
- Hôpitaux Universitaires de Genève
-
Contact:
- Véronique Menoni, PhD
- Phone Number: +41223729195
- Email: veronique.menoni@hcuge.ch
-
Principal Investigator:
- Christophe Luthy, Prof
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals enrolled in an inpatient 3-week cardiac exercise-based rehabilitation programme
- Age range 50-75 years
- Can withstand the study protocol without undue risk
- Able to provide written consent
Exclusion Criteria:
- Contraindication to physical activity in view of the health status
- Presence of cognitive or psychological disorder
- Hearing impairment with or without hearing aids
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MFH
Music in the First Half of the Exercise Session
|
Exposure to music played at different phases of the physical activity
|
|
Experimental: MSH
Music in the Second Half of the Exercise Session
|
Exposure to music played at different phases of the physical activity
|
|
Experimental: MT
Music Throughout the Exercise Session
|
Exposure to music played at different phases of the physical activity
|
|
No Intervention: Control
Exercice Session without any music
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Affective valence during the moderate intensity continuous training
Time Frame: 22 minutes
|
Mesured with filling scale (FS)
|
22 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Affective arousal during the moderate-intensity continuous training
Time Frame: 25 minutes
|
Affective arousal will be measured at five time points ( Minute 3, Minute 12, Minute 13, Minute 22, and Minute 25) using the Felt Arousal Scale (Svebak & Murgatroyd, 1985), a single-item bipolar rating scale using the sentence "How aroused do you actually feel?" with possible responses ranging from 1 (low arousal) to 6 (high arousal).
|
25 minutes
|
|
Rating of perceived exertion during the moderate-intensity continuous training
Time Frame: 5 minutes after each training session
|
Remembered pleasure will be measured 5 min after each training session using a visual analogy scale presented on a Samsung Galaxy Tab ranging from -100 (very unpleasant) to +100 (very pleasant) in intervals of 1 (Zenko et al., 2016).
Participants will be asked to answer the following question: "How did the exercise session make you feel?" (Hutchinson et al., 2023).
|
5 minutes after each training session
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0424
- SNCTP000006164 (Other Identifier: HumRes)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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