Heart Rate Variability Biofeedback in Older Adults

Early Phase 1

Completed

• Conditions: Older Adult

• Registration Number: NCT05902286
• Lead Sponsor: Brigham Young University

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.

Study Timeline

• Study Start: 2023-02-17
• Study First Submitted: 2023-04-02
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-13
• Primary Completion: 2024-05-22
• Study Completion: 2024-05-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Resting HRV Change Following Intervention	Through study completion, an average of 7 weeks.	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.
Stress Recovery Change Following Intervention	Through study completion, an average of 7 weeks.	The first primary aim of the paper is to test whether there will be difference resting HRV measurements pre- to post-intervention.

Secondary Outcome Measures

Name	Time	Method
Emotional Functioning: Geriatric Depression Scale-15	Through study completion, an average of 7 weeks.	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).
Cognitive Functioning	Through study completion, an average of 7 weeks.	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.
Emotional Functioning: Satisfaction with Life Scale	Through study completion, an average of 7 weeks.	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.
Emotional Functioning: Scale of Positive and Negative Emotions	Through study completion, an average of 7 weeks.	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.
Emotional Functioning: Depression and Stress Anxiety Scale	Through study completion, an average of 7 weeks.	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).

Trial Locations

Locations (1)

Brigham Young Unversity; 🇺🇸 Provo, Utah, United States