Trial Outcomes & Findings for Singing and Cardiovascular Health in Older Adults (NCT NCT04121741)

Last Updated: 2025-02-05

Results Overview

Assess macrovascular endothelial function by assessing changes in post-intervention to pre-intervention changes in brachial artery FMD%.

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

At baseline and after 30-minute singing and control intervention(s)

Results posted on

2025-02-05

Participant Flow

Recruitment began in January of 2020 and concluded in August 2023 as enrollment goals were met successfully. Subjects were identified by reviewing the electronic medical records of patients visiting the outpatient clinic. Subjects were also identified using a cohort discovery tool from the institution's Clinical Research Data Warehouse.

Randomized, single-blind, crossover, sham procedure-controlled design. Each subject will have 3 visits: (1) a 30-minute period of guided singing from a music therapist, (2) a 30-minute period of singing along to an instructional video (3) a 30-minute rest period without any intervention. There will be a washout period between visits of a minimum of 2 days and a maximum of 7 days (to allow for wash-out effects of the prior intervention). Visits are coded ABC. A-Control, B-Coach, C-video

Participant milestones

Participant milestones
Measure	Randomization ABC A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.	Randomization ACB A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.	Randomization BAC A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.	Randomization BCA A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.	Randomization CAB A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.	Randomization CBA A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.
Overall Study STARTED	11	11	10	11	11	11
Overall Study COMPLETED	10	11	10	11	11	11
Overall Study NOT COMPLETED	1	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Randomization ABC A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.	Randomization ACB A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.	Randomization BAC A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.	Randomization BCA A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.	Randomization CAB A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.	Randomization CBA A- Control B- Singing Intervention with Coach C- Singing Intervention with Sing-a-long Video Control Visit: 30 minute rest period, no singing will take place during this arm. This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.
Overall Study Protocol Violation	1	0	0	0	0	0

Baseline Characteristics

One subject was unable to get a hearing test performed during the study procedures as the app that was used to perform the test malfunctioned and would not open due to needing an update.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=65 Participants All 65 participants who signed informed consent and participated in this study.
Age, Customized Age at Screening	67.7 years n=65 Participants
Sex: Female, Male Female	26 Participants n=65 Participants
Sex: Female, Male Male	39 Participants n=65 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=65 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=65 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=65 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=65 Participants
Race (NIH/OMB) Asian	1 Participants n=65 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=65 Participants
Race (NIH/OMB) Black or African American	7 Participants n=65 Participants
Race (NIH/OMB) White	56 Participants n=65 Participants
Race (NIH/OMB) More than one race	0 Participants n=65 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=65 Participants
Region of Enrollment United States	65 participants n=65 Participants
History of Heart Attack (Myocardial Infarction)	41 participants n=65 Participants
History of Stent Placement	47 participants n=65 Participants
History of Coronary Artery Bypass (CABG)	18 participants n=65 Participants
History of Diabetes Mellitus	19 participants n=65 Participants
History of Hypertension	49 participants n=65 Participants
History of High Cholesterol	55 participants n=65 Participants
History of Chronic Kidney Disease	10 participants n=65 Participants
History of Respiratory Illness	18 participants n=65 Participants
History of Past Smoking	26 participants n=65 Participants
History of Heart Failure	12 participants n=65 Participants
Body Mass Index (BMI) Category Underweight <18.5	4 participants n=65 Participants
Body Mass Index (BMI) Category Healthy weight 18.5 - 24.9	12 participants n=65 Participants
Body Mass Index (BMI) Category Overweight 25 to 29.9	17 participants n=65 Participants
Body Mass Index (BMI) Category Obese 30 or greater	32 participants n=65 Participants
Godin Category Less than 14 Insufficiently Active	10 participants n=65 Participants
Godin Category 14-23 Moderately Active	10 participants n=65 Participants
Godin Category 24 or more Active	45 participants n=65 Participants
Hearing Test Results - Left Ear Normal	20 participants n=64 Participants • One subject was unable to get a hearing test performed during the study procedures as the app that was used to perform the test malfunctioned and would not open due to needing an update.
Hearing Test Results - Left Ear Mild Loss	14 participants n=64 Participants • One subject was unable to get a hearing test performed during the study procedures as the app that was used to perform the test malfunctioned and would not open due to needing an update.
Hearing Test Results - Left Ear Moderate Loss	22 participants n=64 Participants • One subject was unable to get a hearing test performed during the study procedures as the app that was used to perform the test malfunctioned and would not open due to needing an update.
Hearing Test Results - Left Ear Severe Loss	8 participants n=64 Participants • One subject was unable to get a hearing test performed during the study procedures as the app that was used to perform the test malfunctioned and would not open due to needing an update.
Hearing Test Results - Right Ear Normal	22 participants n=64 Participants • One subject was unable to get a hearing test performed during the study procedures as the app that was used to perform the test malfunctioned and would not open due to needing an update.
Hearing Test Results - Right Ear Mild Loss	8 participants n=64 Participants • One subject was unable to get a hearing test performed during the study procedures as the app that was used to perform the test malfunctioned and would not open due to needing an update.
Hearing Test Results - Right Ear Moderate Loss	25 participants n=64 Participants • One subject was unable to get a hearing test performed during the study procedures as the app that was used to perform the test malfunctioned and would not open due to needing an update.
Hearing Test Results - Right Ear Severe Loss	9 participants n=64 Participants • One subject was unable to get a hearing test performed during the study procedures as the app that was used to perform the test malfunctioned and would not open due to needing an update.

PRIMARY outcome

Timeframe: At baseline and after 30-minute singing and control intervention(s)

Population: Poor quality FMD measurements were excluded from the analysis

Assess macrovascular endothelial function by assessing changes in post-intervention to pre-intervention changes in brachial artery FMD%.

Outcome measures

Outcome measures
Measure	Singing Intervention 1 n=63 Participants Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after singing. Singing with Guided Video: The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.	Singing Intervention 2 n=62 Participants In-person music therapy session. The music therapist will continue to coach throughout the 30-minute session. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after singing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Music therapy sessions will be led by Erica Flores, MT-BC, WMTR, Owner of Healing Harmonies Music Therapy, or a member of her team. Erica and her team of MTs were trained in Neurological Music Therapy.	Control/Sham Intervention n=61 Participants Subjects will have a 30-minute period of rest sitting upright (as they would be positioned for the singing interventions). This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after the 30 minute rest. Control Arm: 30 minute rest period, no singing will take place during this arm. During this rest period a member of the study team will assist the subject in a hearing test using headphones, a tablet, and a trumpet app. This is done to asses the current hearing level of the subject.
Change in FMD%	-0.06 FMD percent Standard Error 0.30	-0.11 FMD percent Standard Error 0.31	-0.06 FMD percent Standard Error 0.31

PRIMARY outcome

Timeframe: At baseline and after 30-minute singing and control intervention(s)

Population: Poor quality EndoPAT measurements were excluded from the analysis

Assess microvascular endothelial function by measuring changes in reactive hyperemia index through finger plethysmography using EndoPAT. A larger post-intervention to pre-intervention change in RHI is considered a better outcome.

Outcome measures

Outcome measures
Measure	Singing Intervention 1 n=50 Participants Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after singing. Singing with Guided Video: The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.	Singing Intervention 2 n=57 Participants In-person music therapy session. The music therapist will continue to coach throughout the 30-minute session. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after singing. Singing with Music Therapist: Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Music therapy sessions will be led by Erica Flores, MT-BC, WMTR, Owner of Healing Harmonies Music Therapy, or a member of her team. Erica and her team of MTs were trained in Neurological Music Therapy.	Control/Sham Intervention n=54 Participants Subjects will have a 30-minute period of rest sitting upright (as they would be positioned for the singing interventions). This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after the 30 minute rest. Control Arm: 30 minute rest period, no singing will take place during this arm. During this rest period a member of the study team will assist the subject in a hearing test using headphones, a tablet, and a trumpet app. This is done to asses the current hearing level of the subject.
Change in Reactive Hyperemia Index (RHI)	0.22 Index Standard Error 0.10	0.19 Index Standard Error 0.11	0.12 Index Standard Error 0.09

PRIMARY outcome

Timeframe: At baseline and after 30-minute singing and control intervention(s)

Population: Poor quality EndoPAT measurements were excluded from the analysis

Assess microvascular endothelial function by measuring changes in Framingham reactive hyperemia index through finger plethysmography using EndoPAT. A larger post-intervention to pre-intervention change in fRHI is considered a better outcome.