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Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients (MUSIC-CPX)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music
Sponsored by
Peggy J Hardesty
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiopulmonary stress test, Exercise stress test, Cardiology, Exercise performance, Heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults (age >18 years)
  • Able to consent
  • English speaking

Exclusion Criteria:

  • Severe hearing deficiency
  • Unable to exercise.

Sites / Locations

  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music

Non-music

Arm Description

Music arm will listen to pre-selected music during their duration of the exercise testing via headphones that will be provided to the patients by the study personnel.

Non-music arm will not have pre-selected music playing during their duration of the exercise testing via the headphones provided to the patients by the study personnel.

Outcomes

Primary Outcome Measures

Difference in O2 consumption (VO2) [L/min]
Assess above performance parameters in CPX and compare between Music and Non-Music arm.
Difference in CO2 production (VCO2) [L/min]
Assess above performance parameters in CPX and compare between Music and Non-Music arm.
Difference in respiratory exchange ratio (RER)
Assess above performance parameters in CPX and compare between Music and Non-Music arm.
Difference in Minute Ventilation (VE) [L/min]
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Difference in Ventilatory Threshold (VT) [L]
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Difference in respiratory rate (RR) [Breaths per minute]
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Difference in Ventilatory Equivalent of CO2 (VE/VCO2)
Assess above performance parameters in CPX and compare between Music and Non-Music arm

Secondary Outcome Measures

Difference in Heart Rate [Beats per minute]
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Difference in O2 Pulse [ml]
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Difference in Systolic and Diastolic Blood Pressure [mmHg]
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Difference in Exercise time [mm:ss]
Compare the CPX parameter between Music and Non-Music Arm
Difference in Work rate [watt]
Compare the CPX parameter between Music and Non-Music Arm

Full Information

First Posted
September 9, 2022
Last Updated
August 8, 2023
Sponsor
Peggy J Hardesty
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1. Study Identification

Unique Protocol Identification Number
NCT05537467
Brief Title
Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients
Acronym
MUSIC-CPX
Official Title
Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peggy J Hardesty

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to assess the effect of music on the heart resulting in a change in their exercise capacity among systolic heart failure patients undergoing Cardiopulmonary Exercise testing.
Detailed Description
Studies have previously shown the positive impact of music on the autonomic nervous system, neurohormonal and cardiovascular system. In addition, a previously published study found a positive impact of music resulting in an improvement of quality of life (QOL) in heart failure patients. Proposed mechanisms of benefit of music in heart failure include a reduction in sympathetic activity, and modulation of parasympathetic activity. Further, reduction in anxiety and arterial relaxation are thought to be beneficial effects of music. It is hypothesized that heart failure patients listening to music would have better exercise stress test performance and increased exercise time. Adult patients with systolic heart failure scheduled to undergo Cardiopulmonary Exercise (CPX) testing at the Gill Heart and Vascular Institute will be recruited. While the patients are undergoing Cardiopulmonary exercise testing, patients randomized to the 'music arm' will listen to pre-selected upbeat music during their duration of the exercise testing via headphones that will be provided to patients by the study personnel. The patients who are randomized to 'non-music arm' in which their headphones will not play music and the patients will perform the cardiopulmonary exercise testing as usual. Standard clinical care is performing cardiopulmonary exercise testing without any music. The investigators will then compare the results of CPX study of the two arms to assess the impact of music on exercise performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiopulmonary stress test, Exercise stress test, Cardiology, Exercise performance, Heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music
Arm Type
Experimental
Arm Description
Music arm will listen to pre-selected music during their duration of the exercise testing via headphones that will be provided to the patients by the study personnel.
Arm Title
Non-music
Arm Type
No Intervention
Arm Description
Non-music arm will not have pre-selected music playing during their duration of the exercise testing via the headphones provided to the patients by the study personnel.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
Patients randomized to the music group will listen to upbeat music using headphones.
Primary Outcome Measure Information:
Title
Difference in O2 consumption (VO2) [L/min]
Description
Assess above performance parameters in CPX and compare between Music and Non-Music arm.
Time Frame
15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Title
Difference in CO2 production (VCO2) [L/min]
Description
Assess above performance parameters in CPX and compare between Music and Non-Music arm.
Time Frame
15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Title
Difference in respiratory exchange ratio (RER)
Description
Assess above performance parameters in CPX and compare between Music and Non-Music arm.
Time Frame
15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Title
Difference in Minute Ventilation (VE) [L/min]
Description
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Time Frame
15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Title
Difference in Ventilatory Threshold (VT) [L]
Description
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Time Frame
15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Title
Difference in respiratory rate (RR) [Breaths per minute]
Description
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Time Frame
15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Title
Difference in Ventilatory Equivalent of CO2 (VE/VCO2)
Description
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Time Frame
15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Secondary Outcome Measure Information:
Title
Difference in Heart Rate [Beats per minute]
Description
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Time Frame
15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Title
Difference in O2 Pulse [ml]
Description
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Time Frame
15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Title
Difference in Systolic and Diastolic Blood Pressure [mmHg]
Description
Assess above performance parameters in CPX and compare between Music and Non-Music arm
Time Frame
15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)
Title
Difference in Exercise time [mm:ss]
Description
Compare the CPX parameter between Music and Non-Music Arm
Time Frame
15 minutes (Start to end of CPX study)
Title
Difference in Work rate [watt]
Description
Compare the CPX parameter between Music and Non-Music Arm
Time Frame
15 minutes (Start to end of each CPX study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (age >18 years) Able to consent English speaking Exclusion Criteria: Severe hearing deficiency Unable to exercise.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peggy J Hardesty, APRN, MSN
Phone
859-323-0295
Email
peggy.hardesty@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mindy Thompson, MBA
Phone
8595523386
Email
mindy.thompson@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peggy J Hardesty, APRN, MSN
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peggy J Hardesty, APRN, MSN
Phone
859-323-0295
Email
peggy.hardesty@uky.edu
First Name & Middle Initial & Last Name & Degree
Mindy Thompson, MBA
Phone
(859) 562-0902
Email
mindy.thompson@uky.edu
First Name & Middle Initial & Last Name & Degree
Samiullah Arshad, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients

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