Heart Rate Variability Biofeedback in Older Adults

Older Adult Clinical Trial

Official title:

A Randomized Controlled Study of Heart Rate Variability Biofeedback in an Older Adult Sample

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902286
• Other study ID #: HRVB_OA
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 17, 2023
• Est. completion date: April 24, 2024

Study information

• Verified date: June 2023
• Source: Brigham Young University
• Contact: Whitney D Allen, M.S.
• Phone: 2088817186
• Email: whitneyallen722[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Older adults will be randomly assigned to an active heart rate variability biofeedback condition and a "sham" control condition. Stress recovery measures and emotional and cognitive functioning will be assessed before and following the five-week intervention to assess potential changes from the intervention.

Description:

The goal of the current study is to compare heart rate variability biofeedback in an older adults study. The primary aims of the paper are to test whether there will be differences between HRV measurements pre- to post-intervention for HRV outcomes, stress recovery, and emotional and cognitive outcome measures. The investigators will implement an active HRVB condition and a control condition that utilizes methods developed by Yoo and colleagues. The "sham" control condition is designed to decrease the syncing of the baroreceptors and respiratory sinus arrhythmia and decrease heart rate oscillations. The target sample will be 50 older adults 65 years and older that will be randomized into the two groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 24, 2024
• Est. primary completion date: April 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Fluent English speaker

• Able to provide informed consent

• 65 years or Older

Exclusion Criteria:

• Symptoms within the last year of a neurological disorder (e.g., dementia, stroke, epilepsy, traumatic brain injury with loss of consciousness in the last year, etc.).

• Conditions that might affect the biofeedback training (i.e., pacemakers, previous self-reported heart attack with hospitalization, self-reported coronary artery disease)

• Currently engaged in or have been previously trained in heart rate variability biofeedback.

• 3.3 or higher on the IQCODE.

• Currently prescribed and taking beta-blockers.

Related Conditions & MeSH terms

• Older Adult

Intervention

Behavioral:
• OSC+
The first session of the HRVB intervention will focus on introducing the client to HRVB and calculating the participant's resonance frequency which typically range from 4.5-7 breaths per minute. Participants will first complete a five-minute baseline breathing condition. Following the breathing condition, the participants will complete five conditions for five minutes each. Specifically, each condition will have the person breath at 6, 6.5, 5.5, 5, and 4.5 breaths per minute with a minute break between. Session two will focus on practicing resonance frequency breathing and solidifying the correct resonance frequency for the participant. Additionally, this session will introduce the technique of breathing through pursed lips and abdominal breathing. For sessions three through five, participants will practice resonance frequency breathing and review previous strategies.
• OSC-
During the first week, the baseline will be assessed and resonance frequency. Specifically, during their first intervention session the participants will be told that the goal of the sessions includes decreasing heart rate variability and avoiding slow and steady breathing. The participants will then be asked to choose five strategies to lower their heart rate oscillations. Participants will be told to avoid slow breathing as it causes large heart rate oscillations. For the second session, the therapist will check in with the participant and discuss how the practice went. Participants will then select three strategies that they will practice for three five-minute conditions following a five-minute baseline. Sessions three, four, and five will include three conditions: a five-minute baseline and two strategies of their choice. For each session, the best strategy will be calculated and written on the assignment sheets to be used during the week for their four homework sessions.

Locations

Country	Name	City	State
United States	Brigham Young Unversity	Provo	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Brigham Young University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress Recovery Change Following Intervention	The first primary aim of the paper is to test whether there will be difference resting HRV measurements pre- to post-intervention.	Through study completion, an average of 7 weeks.
Primary	Resting HRV Change Following Intervention	The second primary aim of the study will be to test the utility of HRVB compared to sham control in improving HRV following a stressor in older adults using a randomized trial design.	Through study completion, an average of 7 weeks.
Secondary	Emotional Functioning: Satisfaction with Life Scale	One of the secondary aims is to evaluate whether change in HRV in older adults following HRVB are associated with subjective change in life satisfaction. To understand change in life satisfaction, researchers will have participants complete the Satisfaction with Life Scale during pre and post intervention testing sessions. The scale has a range of 5-35 with 5-9 representing extreme dissatisfaction with life and 31-35 with extremely satisfied with life.	Through study completion, an average of 7 weeks.
Secondary	Emotional Functioning: Scale of Positive and Negative Emotions	As further evidence of potential changes in self-reported emotional functioning, all participants will complete the Scale of Positive and Negative Emotions. The scale results in a summed positive and negative score that ranges from 6 to 30 that will both be considered in analyses.	Through study completion, an average of 7 weeks.
Secondary	Emotional Functioning: Geriatric Depression Scale-15	The researchers are interested in how self-reported depressive symptoms might change following intervention. To assess self-reported depression levels, all participants will be administered the Geriatric Depression Scale-15. The questionnaire scoring has four ranges reflecting depression severity: 0-4 (normal), 5-8 (mild); 9-11 (moderate); 12-15 (severe).	Through study completion, an average of 7 weeks.
Secondary	Emotional Functioning: Depression and Stress Anxiety Scale	Lastly, to assess both self-reported depression and anxiety all participants will complete the Depression and Anxiety Stress Scale to examine potential changes following intervention. The questionnaire scoring has four separate ranges for depression, stress, and anxiety. Specifically, depression severity ranges included: 0-9 (normal), 10-13 (mild); 14-20 (moderate), 21-27 (severe), 28+ (extremely severe). Stress severity ranges included: 0-14 (normal), 15-18 (mild), 19-25 (moderate), 26-33 (severe), 34+ (extremely severe). Lastly, the anxiety ranges are 0-7 (normal), 8-9 (mild), 10-14 (moderate),15-19 (severe), 20+ (extremely severe).	Through study completion, an average of 7 weeks.
Secondary	Cognitive Functioning	An additional aim of the study is to evaluate whether improvements in HRV in older adults following HRVB are associated with objective and subjective improvements in cognitive functioning (i.e., attention, inhibitory control). The investigators will be using the National Institute of Health (NIH) Toolkit to assess cognitive functioning.	Through study completion, an average of 7 weeks.