Self-care in Older Frail Persons With Heart Failure Intervention (SOPHI). Individualized Physical Exercise, Diet and Symptom Management- A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Change in physical performance
研究概览
简要总结
The overall purpose of the randomized controlled study is to evaluate the effects of physical exercise, nutrition and symptom management on physical capacity in older, frail persons with heart failure.
详细描述
The randomized controlled study will be conducted in order to evaluate the effects of individual needs of physical exercise, nutrition, and symptom management in patients with heart failure who are frail and older. Patients discharged from a geriatric hospital will be recruited and included after informed consent. Two weeks after hospital discharge patients are randomized to intervention or control group. The intervention period is 3 months. With support from a physioterapeut, dietician and a registered nurse, the intervention will be performed in the participants´ home. Once a week participants will come to the hospital for physical exercise led by a physiotherapist. Once a week or every other week participants will meet a dietician and a nurse. Data will be collected at baseline, and 3 and 6 months after baseline. Data consist of e.g. study flow description, number of eligible patients, number of drop-outs, patients sociodemographic- and clinical data, physical function and performance, nutritional status, symptom burden, self-care, appetite, thirst, health-related quality of life. At 12 months after baseline, data will be collected on hospital admissions, reasons for hospital admissions, length of stay and mortality.
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
- Single (Outcomes Assessor)
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 at geriatric clinic
- •Diagnosed with heart failure (independent of Ejection Fraction (EF): both patients with preserved EF or reduced EF can be included
- •New York Heart Association functional class II - III
- •Clinical frailty level 4-6 (moderate frailty)
- •Discharge from hospital to home
排除标准
- •New York Heart Associacion functional class I or IV
- •Clinical frailty level 1-3 (no/mild frailty) and 7-9 (severe frailty)
- •The patient is unable to perform gait tests due to visual (see a TV screen at a 3 meter distance), cognitive (assessed by nurse or doctor) or motor impairment (the patient should be able to stand up from sitting and have the ability to walk with or without a walker or other walking aid).
- •The patient is unable to follow instructions (assessed by nurse or doctor)
结局指标
主要结局
Change in physical performance
时间窗: 3 months
The "Short Physical Performance Battery" is composed of "standing balance", "gait speed", and "timed repeated chair rise". The total score range from minimum 0 to maximum 12, with higher scores indicating better physical performance.
次要结局
- Perceived physical effort(Baseline, 3 and 6 months)
- Aerobic capacity/endurance(Baseline, 3 and 6 months)
- Frailty(Baseline, 3 and 6 months)
- Hand strength(Baseline, 3 and 6 months)
- Sarcopenia(Baseline, 3 and 6 months)
- Symptom burden(Baseline, 3 and 6 months)
- Lower body strength(Baseline, 3 and 6 months)
- Inflammation marker(Baseline, 3 and 6 months)
- Health related quality of life(Baseline, 3 and 6 months)
- Hospital readmissions(12 months)
- Nutrition status(Baseline, 3 and 6 months)
研究者
Nana Waldreus
Principal Investigator
Karolinska Institutet