Heart Rate Variability Biofeedback in Older Adults

NCT ID: NCT05902286

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-17
• Study Completion Date: 2024-05-22

Brief 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.

Detailed 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.

Conditions

Older Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OSC+

The 25 participants assigned to the OSC+ condition will complete a five-week intervention for the Osc+ portion of the study using emWave software for biofeedback. There will be one 30-60 minute in-person HRVB session once a week completed at the University Parkway Center. In addition to the in-person session, the participant will complete four 20-minute homework sessions during the following week. The format of five weeks of one weekly session and four homework sessions is effective at helping participants learn and implement breathing and biofeedback skills. The five HRVB session will be based on the Lehrer and colleagues' protocol.

Group Type: EXPERIMENTAL

OSC+

Intervention Type: BEHAVIORAL

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-

Similarly, for the Osc- procedures, the client will be required to complete a five-week intervention. Participants will be instructed that the purpose of this portion of the study is to decrease their breathing oscillations. A program was designed by Yoo and colleagues that gives feedback regarding a "calmness" score which reflects a better score (i.e., higher) when participants breathe in a pattern that elicits less variability (i.e., less oscillations). They will be asked to complete four 20-minute homework assignments at home and asked to come up with techniques to decrease their heart rate.

Group Type: SHAM_COMPARATOR

OSC-

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham Young University

OTHER

Sponsor Role: lead

Responsible Party

Whitney Allen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael J Larson, Ph.D.

Role: STUDY_CHAIR

Brigham Young University

Locations

Brigham Young Unversity

Provo, Utah, United States

Countries

United States

Other Identifiers

HRVB_OA

Identifier Type: -

Identifier Source: org_study_id