Pilot Study for Breathing Interventions in Congestive Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Feasibility of intervention administration measured by frequency of visits
研究概览
简要总结
Slow breathing may reduce stress. Adults with congestive heart failure have higher stress than the general population. This study will examine if using slow breathing is feasible among adults with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented heart failure from medical chart review with signs and symptoms consistent with disease
- •Reduced left ventricular function with ejection fraction of less than or equal to 40%
- •English speaking
排除标准
- •New York Heart Failure Association Class I or IV
- •Myocardial infarction in the last 3 months
- •Cardiac surgery in the last 3 months
- •Significant valvular heart disease
- •Uncontrolled cardiac arrhythmias
- •Uncontrolled diabetes mellitus (hemoglobin a1c ≥ 8)
- •Uncontrolled hypertension
- •Systolic greater than 140 mmHg
- •Diastolic greater than or 90 mmHg
- •Cognitive impairment (Mini-mental state exam less than or equal to 24)
- •Acute major depression in the last 3 months
- •Other psychiatric conditions including schizophrenia or bipolar disorder
- •Attention-deficit-disorder or attention-deficit-hyperactivity disorder
- •Musculoskeletal condition limiting capacity to perform simple movements such as significant chronic lower back pain or neck pain
- •Unstable or severe chronic lung conditions
- •Current participation in a mind-body practice/program
- •Current cancer other than non-melanoma skin cancer
- •Regular swimmer
- •Plays wind or brass musical instruments
研究组 & 干预措施
Slow breathing
Slow breathing techniques with exhale greater than inhale
干预措施: Slow breathing techniques (Behavioral)
结局指标
主要结局
Feasibility of intervention administration measured by frequency of visits
时间窗: Weekly for 12 weeks
Investigators will document weekly attendance
Feasibility of intervention administration measured by home practice adherence
时间窗: Weekly for 12 weeks
Investigators will ask participants how often they practiced yoga at home since last session
Safety of yoga practice as measured by occurrence of adverse events
时间窗: Weekly for 12 weeks
Investigators will monitor for adverse events related to yoga practice during the intervention and will solicit any adverse events during home practice since last meeting.
Feasibility of intervention administration measured by patient satisfaction
时间窗: One time, at 12 week survey
A survey will be administered that assesses participant satisfaction with the yoga. Overall satisfaction will be assessed by "Very Unsatisfied", "Unsatisfied", "Satisfied", "Very Satisfied".
次要结局
- Magnitude of change in PROMIS Anxiety scale(Baseline, 6 week, 12 week)
- Magnitude of change in PROMIS Global Health scale(Baseline, 6 week, 12 week)
- Magnitude of change in PROMIS Depression scale(Baseline, 6 week, 12 week)
- Magnitude of change in PROMIS Fatigue scale(Baseline, 6 week, 12 week)
- Magnitude of change in PROMIS Physical Function scale(Baseline, 6 week, 12 week)
- Magnitude of change in PROMIS Dyspnea scale(Baseline, 6 week, 12 week)
- Autonomic tone(Monthly data extraction from ICD: Baseline, week 4, week 8, week 12)