Singing and Cardiovascular Health in Older Adults

NCT04121741 | Completed Results

• 2 other identifiers: 35864R33AT010680
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease (CVD) claims more lives each year than cancer and chronic respiratory disease combined. Participation in cardiac rehabilitation (CR) reduces mortality and risk of a major cardiovascular event in secondary prevention populations, including older adults. Older adults are less likely to participate in CR, as comorbidities in this population, including arthritis and chronic obstructive pulmonary disease, make participation difficult. Singing is a physical activity that involves components of the vagal nerves manifested as changes in cardiac autonomic regulation. Unlike physical exercise, the effects of singing on cardiovascular health has not been well-studied. The hypothesis for this project is that older patients with CVD will have favorable improvement in cardiovascular biomarkers, including, endothelial function and heart rate variability (HRV), after 30 minutes of singing.

Conditions

Cardiovascular Diseases; Cardiovascular Risk Factor; Cardiovascular Health

Keywords

Singing

Outcome Measures

Primary Outcomes (3)

• Change in FMD%

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

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

• Change in Reactive Hyperemia Index (RHI)

  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.

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

• Change in Framingham Reactive Hyperemia Index (fRHI)

  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.

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

Secondary Outcomes (7)

• BORG Rating of Perceived Exertion

  after 30-minute singing (and sham) interventions

• Change in SDNN (Standard Deviation of Normal-to-Normal Intervals)

  at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)

• Change in RMSSD (Root Mean Square of Successive Differences)

  at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)

• Change in HF Power (High-frequency Power)

  at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)

• Change in LF Power (Low-frequency Power)

  at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)

Other Outcomes (2)

• Change in TNF-alpha, IL-1 Beta, IL-6, and IL-8

  at baseline and 30 minutes later (after interventions or sham)

• Visual Mood Score

  at baseline and 30 minutes later (after interventions or sham)

Study Arms (3)

Singing intervention 1

ACTIVE COMPARATOR

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.

Other: Singing with Guided Video

Singing intervention 2

ACTIVE COMPARATOR

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.

Other: Singing with Music Therapist

Control/sham intervention

SHAM COMPARATOR

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.

Other: Control Arm

Interventions

Singing with Music Therapist OTHER

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.

Singing intervention 2

Singing with Guided Video OTHER

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 1

Control Arm OTHER

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.

Control/sham intervention

Eligibility Criteria

• Age: 55 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English Speaking
• Have a history of coronary artery disease (defined as history of myocardial infarction, coronary stenosis \>50%, percutaneous coronary intervention with stent placement, balloon angioplasty, or coronary arterial bypass grafting)

You may not qualify if:

• Subjects with a permanent pacemaker or implantable cardioverter defibrillator (ICD) implanted
• Patients with a history of atrial fibrillation, flutter or atrial tachycardia
• Parkinson's disease or a tremor
• Amputated upper extremity or presence of upper-arm (dialysis) fistula
• Fingernail onychomycosis (fungal infections resulting in thickening of the nails)
• Pregnancy
• Current illicit drug use (marijuana, tobacco, cocaine, amphetamines, etc.)
• Current excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men)
• Unstable coronary heart disease (active symptoms of chest discomfort)
• History of a Stroke or TIA or peripheral arterial disease
• Known history of cognitive impairment or inability to follow study procedures
• Cancer requiring systemic treatment within five years of enrollment.
• Subjects requiring supplemental oxygen use
• Non-English speaking subjects (video with lyrics are taped in English)

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of singing on vascular health in older adults with coronary artery disease: a randomized, crossover trial. Front Cardiovasc Med. 2025 Apr 28;12:1546462. doi: 10.3389/fcvm.2025.1546462. eCollection 2025.

  PMID: 40357442 DERIVED

• Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv [Preprint]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033.

  PMID: 39108506 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Singing

Intervention Hierarchy (Ancestors)

Phonation; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Limitations and Caveats

1. Due to technical issues related to image quality, machine/equipment malfunctions, and/or too much patient movement/patient related signal interference during testing, not all of the FMD, EndoPAT, and heart rate variability tests were included or analyzed in the final data set. 2. Due to the COVID-19 pandemic, 20 out of 64 coaching intervention visits were conducted by the singing coach remotely (via Microsoft teams) to limit any exposure for study staff and research subjects.

Results Point of Contact

• Title: Principal Investigator: Jacquelyn P Kulinski
• Organization: Medical College of WI

jakulinski@mcw.edu

414-955-6896

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 10, 2019
• Study Start: January 17, 2020
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-01

Locations

US (1)