Impact of a Program Aimed at Improving Frailty in Patients With Stable Ischemic Heart Disease in Primary Care: Fragicor Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Short Physical Performance Battery (SPPB) components (balance, gait speed, chair rise)
研究概览
简要总结
The goal of this clinical trial is to improve the frailty in old patients who have a cardiac disease .
Researchers will determine the improvement in the instability and the strength along twelve sessions based on guided exercises and mobility techniques made by physiotherapists. Research team will also evaluate the medications and diet, as well as laboratory and clinical tests.
详细描述
Intitial visit to measure quality of life, instability and strenght, followed by twelve sessions, one each week will be performed
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years
- •Diagnosis of coronary artery disease (International Classification Diseases (ICD)-10 I20-I25)
- •Canadian Cardiovascular Society Class I
- •Low cardiovascular risk according to
排除标准
- •Exclusion Criteria:
- •Inability or refusal to provide informed consent (advanced dementia, severe psychiatric illness)
- •Inability to perform protocol procedures
- •Severe mobility-limiting conditions (Parkinson's disease, progressive neurological disorders, disabling joint disease)
- •Recent (<6 months) unstable angina, myocardial infarction, coronary revascularization or angioplasty
- •Deep venous thrombosis or pulmonary embolism in the last 6 months
- •Recent stroke (<6 months)
- •Heart failure in New York Heart Assocaition functional status (NYHA) III-IV
- •Left ventricular ejection fraction < 50%
- •Symptomatic valvular heart disease
研究组 & 干预措施
Patients with stable coronary heart disease
older than 70 years, idependents in ADL
干预措施: physiotherapy (Other)
结局指标
主要结局
Short Physical Performance Battery (SPPB) components (balance, gait speed, chair rise)
时间窗: From enrollment to the end of treatment ending after 12 weeks.
Improvement in baseline values: each of the three component scores \<= 4 points, and tests consists of: balance test, Gait speed and chair-stand tests. Maximum possible is 12 points and under 10 points means frailty
次要结局
- Euroqol5D Goldberg Anxiety and Depression Scale Number of falls throughout the study Major Cardiovascular events Adherence to the program(from the baseline to 12 weeks of intervention)