Prevalence of Frailty in Patients With a Cardiovascular Disease and Correlations With Markers of Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Cognitive status via the Mini Mental State Examination (MMSE)
研究概览
简要总结
In the first part of this study the prevalence of frailty in patients with cardiovascular disease will be examined. Frailty is defined as a progressive age-related decline in physiological systems that results in decreased reserves of intrinsic capacity, which confers extreme vulnerability to stressors. Patients (≥65 years, men and women) suffering from heart failure or undergoing a coronary artery bypass grafing (CABG) or percutaneous coronary intervention (PCI) will be included. Based on the phenotype of Fried, frailty will be examined in the physical domain. Moreover, the nutritional, social, psychological and cognitive domain of frailty will be examined. This will result in a total score of 0 (no frailty) to 24 (severe frailty), divided into four categories: no frailty (score 0-6), minor frailty (score 7-12), moderate frailty (score 13-18) or severe frailty (score 18-24).
Besides this frailty protocol, a few other measurements will be completed to collect additional information about the functioning of the patient.
At discharge from the hospital, some of these patients will start with a cardiac rehabilitation program. To define the exercise intensity of this program, patients will perform a maximal exercise test (CPET). In the second part of this study, correlations will be examined between markers of frailty and markers of exercise from the CPET (e.g. maximal heart rate, maximal oxygen uptake).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with an age of at least 65 years at the start of the study; Staying in Jessa Hospital for PCI, CABG or heart failure
排除标准
- •A persistently unstable clinical condition at baseline visit (angina, advanced conduction disturbances, threatening ventricular arrhythmias, acute heart failure, clinical condition requiring interventions such as acute renal failure, Hb <9,0 mg/dl, presence of end-stage disease or the lack of informed consent to study participation)
结局指标
主要结局
Cognitive status via the Mini Mental State Examination (MMSE)
时间窗: At baseline
Examination of the cognitive status of the patient via a short screening (30 points)
Psychological status via the Geriatric Depression Scale (GDS-15)
时间窗: At baseline
Examination of the presence/absence of a depressive mood via a questionnaire (15 questions/15 points)
Level of (in)dependence via the Katz scale
时间窗: At baseline
Evaluation of the level of (in)dependence in activities of daily life via a 4-point scale (1-4)
Level of physical activity via the International Physical Activity Questionnaire (IPAQ)
时间窗: At baseline
Examination of the level of physical activity of the patient via a questionnaire
Examination of mobility/balance/muscle strength/risk of falling via the Timed Up and Go Test (TUG)
时间窗: At baseline
The Timed Up and Go Test measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. By combining this test with a motor or cognitive dual task, the risk of falling of the patient will be examined.
Nutritional status via the Mini Nutritional Assessment (MNA)
时间窗: At baseline
Examination of the nutritional status of the patient via a questionnaire (30 points)
Comorbidities via the record of medication use
时间窗: At baseline
Record of cardiac and other medications
Concern about falling via the Falls Efficacy Scale (FES-I)
时间窗: At baseline
Examination of the level of concern about falling during social and physical activities via a questionnaire (16 questions/ 64 points)
Weight loss via the evaluation of body weight
时间窗: At baseline
Evaluation of involuntary loss of body weight in the previous months
Evaluation of handgrip strength
时间窗: At baseline
Evaluation of the handgrip strength of the patient via handheld dynamometry
Gait speed via the 4.6 meter walking test
时间窗: At baseline
Examination of the walking speed of the patient
Evaluation of lower limb strength
时间窗: At baseline
Evaluation of lower limb strength of the patient via Microfet measurements
Evaluation of functional lower limb strength
时间窗: At baseline
Evaluation of functional lower limb strength of the patient via the Timed Chair Stand Test
次要结局
- Correlations between frailty (via the primary frailty outcome measures) and exercise parameters (via the maximal exercise test (CPET)(At the start of the cardiac rehabilitation program)
研究者
Dominique Hansen
Principal Invesigator
Hasselt University