A Randomized Controlled Study of Heart Rate Variability Biofeedback in an Older Adult Sample
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Resting HRV Change Following Intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The testing sessions will be completed by research assistants who are blinded to the participant's condition as not to influence testing results. All participants will be randomized into a condition (e.g., Osc+ or Osc-) by a graduate student so research assistants doing the assessments are blinded to condition.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fluent English speaker
- •Able to provide informed consent
- •65 years or Older
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: OSC+ (Behavioral)
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.
干预措施: OSC- (Behavioral)
结局指标
主要结局
Resting HRV Change Following Intervention
时间窗: 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
时间窗: 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.
次要结局
- Emotional Functioning: Geriatric Depression Scale-15(Through study completion, an average of 7 weeks.)
- Cognitive Functioning(Through study completion, an average of 7 weeks.)
- Emotional Functioning: Satisfaction with Life Scale(Through study completion, an average of 7 weeks.)
- Emotional Functioning: Scale of Positive and Negative Emotions(Through study completion, an average of 7 weeks.)
- Emotional Functioning: Depression and Stress Anxiety Scale(Through study completion, an average of 7 weeks.)
研究者
Whitney Allen
Principal Investigator
Brigham Young University