Early Homebased Rehabilitation for Patients With Severe Heart Failure - An Intersectoral Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Readmission due to heart failure
研究概览
简要总结
The purpose of this study is to investigate the effect of an early, coordinated rehabilitation intervention for patients with severe heart failure in NYHA class III and IV with a ejection fraction of <40% of normal cardiac function measured on frequency of readmissions, physical ability and participation in activities of daily living and quality of life.
详细描述
Approximately 400,000 Danes live today with heart disease. Disease severity is crucial for patients quality of life. Patients with severe heart disease often struggle with everyday life, characterized by reduced physical capacity, tendency to depression and anxiety to perform everyday activities that may provoke symptoms.
A large proportion of patients who are offered cardiac rehabilitation deselect that offer. Of the patients who do participate, more than 50% stop the rehabilitation ahead of time. A large group of patients with severe heart failure and classified in NYHA Class III and IV, deselect the offer because of lack of energy to participate in cardiac rehabilitation or is when specified by a medical assessment discharged from the hospital without the offer of training or any other form of rehabilitation.
The offer of rehabilitation for patients with severe heart failure is lacking as it is today. This study assesses the effectiveness of an early home based rehabilitation program that complements the general psycho-social support, symptom-oriented and preventive medical treatment that these patients always have the option to get.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the Gentofte Hospital due to heart failure.
- •Patients with a functional equivalent to NYHA grade III or IV
- •Patients with ejection fraction <40%
- •Patients who score between10-15 in the total score for question 3 dealing with physical functioning in SF-36 questionnaire on health status
- •Patients who lives in Gentofte Municipality or Lyngby Tårbæk Municipality.
- •Patients who can speak and understand Danish
排除标准
- •Patients with cognitive and psychological problems that prevents cooperation (aphasia, dementia, severe depression).
- •Patients with terminal illness with expected death within a year.
结局指标
主要结局
Readmission due to heart failure
时间窗: assessed one year after inclusion
次要结局
- Physical capacity(Assessed at baseline, after 6 weeks, after 6 month and after one year)
- Activity of Daily Living(Assessed at baseline, after 6 weeks, after 6 month and after one year)
- Number of total hospital admissions(at baseline, after 6 weeks, after 6 month and after one year)
- Exercise Compliance(at baseline, after 6 weeks, after 6 month and after one year)
- Anxiety and depression(at baseline, after 6 weeks, after 6 month and after one year)
- Quality of life(at baseline, after 6 weeks, after 6 month and after one year)
- Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)(at 6 weeks, after 6 month and after one year)
研究者
Laura Staun Valentiner
Research and Development Physiotherapist
University Hospital, Gentofte, Copenhagen