Neuromuscular Electrical Stimulation in Heart Failure Patients to Improve Functional Recovery Following Hospitalization (NeuHF-Recover)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- 6 Minute Walk Distance (6MW)
研究概览
简要总结
The goal of this research study is to understand whether an at-home exercise program started after hospitalization for HFpEF, and continuing for 4 weeks following discharge from the hospital, can preserve or improve physical function.
详细描述
Heart failure is the leading cause of hospitalization among adults in the US with patients with preserved ejection fraction (HFpEF) comprising half of those admissions. Many patients exhibit chronic fatigue, exercise intolerance and an inability to perform activities of daily living, which is exacerbated by hospitalization. The goal of this research study is to understand whether an at-home exercise program started soon after hospitalization and continuing for 4 weeks following discharge can improve functional recovery in HFpEF patients. Volunteers will be randomly assigned to receive neuromuscular electrical stimulation (NMES) of their quadriceps muscles or not to receive NMES (control group). Volunteers will be evaluated during hospitalization and 4 weeks following discharge. Assessments will include measurements of physical function by 6 minute walk test and the Short Physical Performance Battery, as well as assessment of subjective physical functional capacity and quality of life using the Medical Outcomes Short form 36 and Kansas City Cardiomyopathy questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50-90 years of age
- •clinical diagnosis of HF being actively managed during hospitalization
- •live within 30 miles of the medical center
- •able to perform informed consent
排除标准
- •rheumatoid arthritis or other inflammatory/autoimmune disease
- •cancer, excluding non-melanoma skin cancer or low-grade prostate cancer
- •severe dementia/alzheimer's disease
- •exercise limiting peripheral vascular disease
- •neuromuscular disease or neuromuscular dysfunction associated with cerebrovascular event
- •body mass index ≥40 kg/m2
- •lower extremity blood clot or implantable cardioverter-defibrillator or pacemaker
研究组 & 干预措施
Control
No treatment control
Neuromuscular electrical stimulation
Neuromuscular electrical stimulation of the quadriceps. 45 minutes, 5 days per week
干预措施: Neuromuscular electrical stimulation (Device)
结局指标
主要结局
6 Minute Walk Distance (6MW)
时间窗: Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge
6 MW was developed to assess cardiopulmonary fitness in patients with lung and cardiac disease, and has been validated in heart failure patients. It assesses the distance that a patient can walk in 6 minutes time around a standard course.
次要结局
- Short Physical Performance Battery(Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge)
- Medical Outcomes Short Form 36 - Bodily Pain(Hospital discharge (Within 1 day) and 4-weeks post-discharge)
- Medical Outcomes Short Form 36 - Social Function(Hospital discharge (Within 1 day) and 4-weeks post-discharge)
- Medical Outcomes Short Form 36 - Vitality(Hospital discharge (Within 1 day) and 4-weeks post-discharge)
- Medical Outcomes Short Form 36 - Role Emotional(Hospital discharge (Within 1 day) and 4-weeks post-discharge)
- Medical Outcomes Short Form 36(Hospital discharge (Within 1 day) and 4-weeks post-discharge)
- Medical Outcomes Short Form 36 - General Health(Hospital discharge (Within 1 day) and 4-weeks post-discharge)
- Medical Outcome Short Form 36 - Role Physical(Hospital discharge (Within 1 day) and 4-weeks post-discharge)
- Medical Outcomes Short Form 36 - Physical Function(Hospital discharge (Within 1 day) and 4-weeks post-discharge)
- Katz Index of Independence in Activities of Daily Living(Hospital discharge (Within 1 day) and 4-weeks post-discharge)
- Lawton Instrumental Activities of Daily Living (IADL) Scale(Hospital discharge (Within 1 day) and 4-weeks post-discharge)
研究者
Sherrie Khadanga
Associate Director Cardiac Rehabilitation
University of Vermont Medical Center