Clinical trial NCT05902286: Heart Rate Variability Biofeedback in Older Adults
Official title: A Randomized Controlled Study of Heart Rate Variability Biofeedback in an Older Adult Sample
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Older Adult
Lead sponsor: Brigham Young University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 59
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators plan to collect a sample of 50 older adult participants (25 per group) for the current study. Participants who meet the inclusion and exclusion criteria will then be randomized into the Osc+ or Osc- group for the five-week condition. All randomization in this study will be completed using a quasi-random number generator constrained so there are equal numbers of participants in each condition.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Stress Recovery Change Following Intervention
timeFrame: Through study completion, an average of 7 weeks.
measure: Resting HRV Change Following Intervention
timeFrame: Through study completion, an average of 7 weeks.
Secondary outcomes:
measure: Emotional Functioning: Satisfaction with Life Scale
timeFrame: Through study completion, an average of 7 weeks.
measure: Emotional Functioning: Scale of Positive and Negative Emotions
timeFrame: Through study completion, an average of 7 weeks.
measure: Emotional Functioning: Geriatric Depression Scale-15
timeFrame: Through study completion, an average of 7 weeks.
measure: Emotional Functioning: Depression and Stress Anxiety Scale
timeFrame: Through study completion, an average of 7 weeks.
measure: Cognitive Functioning
timeFrame: Through study completion, an average of 7 weeks.
Other outcomes:
Locations:
city: Provo
country: United States
facility: Brigham Young Unversity
state: Utah
Study officials:
affiliation: Brigham Young University
name: Michael J Larson, Ph.D.
role: STUDY_CHAIR
References: