Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study

(CARES Trial)

Overseen By Dara James, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Heart rate medications

Disqualifiers: Regular mind-body practice, pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial excludes participants who are on medications that interfere with heart rate variability, so you may need to stop taking such medications to participate.

What data supports the effectiveness of the treatment Heart Focused Breathing, Music Listening Control (MLC)?

Research shows that controlled breathing can improve heart rate variability (the variation in time between heartbeats) and lower blood pressure, which may help people with heart conditions. Additionally, breathing training has been found to reduce anxiety and breathing difficulties in patients with heart failure. ^{1 2 3 4 5}

Is Heart Focused Breathing safe for humans?

Heart Focused Breathing, also known as heart rate variability biofeedback, has been studied in various settings and appears to be safe for humans. It has been shown to improve heart function and reduce anxiety without causing harmful effects. ^{6 7 8 9 10}

How does Heart Focused Breathing differ from other treatments for heart conditions?

Heart Focused Breathing is unique because it involves controlled breathing techniques that can influence heart rate and autonomic nervous system activity, unlike traditional treatments that may rely on medication. This method can increase sympathetic stimulation of the heart, potentially offering therapeutic benefits by altering heart rate variability and autonomic tone. ^{11 12 13 14 15}

What is the purpose of this trial?

This trial tests a program where caregivers of Alzheimer's patients learn techniques to reduce stress. The goal is to see if this method is practical and if it helps improve their well-being.

Eligibility Criteria

Inclusion Criteria

primary, unpaid family caregiver for ADRD patient for 6 months or more

owns and operates a smartphone with a data plan

greater than of equal to 4 on caregiver burden scale

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week heart rate variability biofeedback (HRVB) intervention or music listening control (MLC)

8 weeks

Follow-up

Participants are monitored for changes in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality

5 weeks

Treatment Details

Interventions

• Heart Focused Breathing
• Music Listening Control (MLC)

Participant Groups

Group I: Heart Focused Breathing Experimental Treatment 1 Intervention

Group II: Music Listening Control(MLC) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Findings from Research

Meditation practices have been shown to significantly improve psychosocial factors, quality of life, and reduce heart failure symptom burden in patients, based on a review of six studies involving 320 heart failure patients.

Despite the positive findings, the studies varied widely in their design and outcome measures, highlighting the need for more standardized and larger trials to better understand the effects of meditation on heart failure outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation interventions among heart failure patients: An integrative review. Viveiros, J., Chamberlain, B., O'Hare, A., et al.[2022]

Heart rate variability biofeedback (HRV-BF) significantly reduced hospital readmissions (12% vs. 25.42%) and emergency visits (13.33% vs. 35.59%) in patients with coronary artery disease over a 1-year period, indicating its effectiveness in improving cardiovascular prognosis.

The HRV-BF group showed long-term improvements in cardiac autonomic function and reductions in depression and hostility, suggesting that HRV-BF is a beneficial intervention for both psychological and physiological health in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Cardiovascular Prognosis of the Randomized, Controlled, Short-Term Heart Rate Variability Biofeedback Among Patients with Coronary Artery Disease. Yu, LC., Lin, IM., Fan, SY., et al.[2021]

In a study of 107 patients with stable chronic heart failure, heart-focused anxiety was primarily predicted by self-reported anxiety levels and quality of life, highlighting the importance of psychological factors in these patients.

Additionally, factors such as conscientiousness, physical activity, and renal function (measured by estimated glomerular filtration rate, eGFR) were also found to be significant predictors of heart-focused anxiety, suggesting that both lifestyle and medical indicators can help identify patients at risk for adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of heart-focused anxiety in patients with stable heart failure. Wedegärtner, SM., Schwantke, I., Kindermann, I., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a controlled breathing protocol on heart rate variability following myocardial infarction or coronary artery bypass graft surgery. [2009]

2. England pubmed.ncbi.nlm.nih.gov

Meditation interventions among heart failure patients: An integrative review. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

Spontaneous respiratory modulation improves cardiovascular control in essential hypertension. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Modulatory effects of respiration. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The effects of breathing training on dyspnea and anxiety among patients with acute heart failure at emergency department. [2021]

6. England pubmed.ncbi.nlm.nih.gov

One-Year Cardiovascular Prognosis of the Randomized, Controlled, Short-Term Heart Rate Variability Biofeedback Among Patients with Coronary Artery Disease. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of heart rate variability biofeedback training in athletes exposed to stress of university examinations. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Predictors of heart-focused anxiety in patients with stable heart failure. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of single trial of heart-rate biofeedback on the arterial blood pressure, ventilation volume, and oxygen consumption during ramp bicycling exercise. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

Positive emotion reduces dyspnea during slow paced breathing. [2012]

11. England pubmed.ncbi.nlm.nih.gov

The effects of unilateral forced nostril breathing on the heart. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Changes in Heart Rate Variability During Heartfulness Meditation: A Power Spectral Analysis Including the Residual Spectrum. [2020]

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The voluntary control of breathing under high-altitude hypoxia]. [2016]

14. India pubmed.ncbi.nlm.nih.gov

Autonomic system modification in Zen practitioners. [2022]

15. Japan pubmed.ncbi.nlm.nih.gov

Consciously controlled breathing decreases the high-frequency component of heart rate variability by inhibiting cardiac parasympathetic nerve activity. [2022]