Impact of Aerobic Exercise Training on Markers of Frailty in Heart Failure and CABG Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in gait speed at 12 weeks
研究概览
简要总结
The aim of this research project is to examine the impact of aerobic exercise on markers of frailty in patients (of 65 years or older) suffering from heart failure (HF) or after coronary artery bypass grafting (CABG) or mini aortic valve replacement procedures (mini-AVR).
详细描述
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. Based on previous research, there are indications that frailty is highly prevalent in HF, CABG and mini-AVR patients. As a consequence, these patients (both men and women of 65 years or older) will be included in this research project. The 12-week aerobic exercise program (3 sessions per week) will consist of ergometer, treadmill and arm-ergometer exercises. The intensity will be based on the maximal cardiopulmonary exercise test (CPET) of the patient and will correspond with a heart rate between the first and second ventilatory threshold (with a gradual progression over time).
Secondary, correlations will be examined between markers of the CPET and frailty markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 of at least 65 years of age at the start of the study
- •To be admitted to Jessa Hospital Hasselt for cardiac rehabilitation after CABG or mini-AVR surgery or because of HF
- •Diagnosed as being frail based on the Phenotype of Fried.
排除标准
- •A persistently unstable clinical condition (e.g. angina, advanced conduction disturbances, threatening ventricular arrhythmias or acute HF)
结局指标
主要结局
Change in gait speed at 12 weeks
时间窗: 12 weeks
To examine the change in gait speed based on the 4.6 metres walking test.
Change in handgrip strength at 12 weeks
时间窗: 12 weeks
To examine the change in handgrip strength measured with the Jamar handheld dynamometer.
Gait speed
时间窗: At baseline (as part of the identification of frailty)
To examine the gait speed based on the 4.6 metres walking test.
Level of physical activity based on the Katz-scale
时间窗: At baseline (as part of the identification of frailty)
To examine the level of physical activity based on the Katz-scale (which measures the level of (in)dependence in activities of daily living) (score of 0-6 in which a higher score indicates a better level of physical activity)
Exhaustion based on 2 questions of the Center of Epidemiologic Studies Depression Scale (CES-D)
时间窗: At baseline (as part of the identification of frailty)
To examine whether the patients suffer from exhaustion based on two questions of the CES-D (in which a score of 2 or 3 on both questions indicates that the patient suffers from exhaustion)
Change in body weight
时间窗: At baseline (as part of the identification of frailty)
To examine whether there was a change in body weight (not due to a diet) in the last year
Change in level of physical activity at 12 weeks (0-6) (Higher score = better level of physical activity)
时间窗: 12 weeks
To examine the change in level of physical activity based on the Katz-scale (which measures the level of (in)dependence in activities of daily living) (score of 0-6 in which a higher score indicates a better level of physical activity)
Change in level of exhaustion at 12 weeks based on 2 questions of the Center of Epidemiologic Studies Depression Scale (CES-D)
时间窗: 12 weeks
To examine whether there is a change in the level of experienced exhaustion based on two questions of the CES-D (in which a score of 2 or 3 on both questions indicates that the patient suffers from exhaustion)
Handgrip strength
时间窗: At baseline (as part of the identification of frailty)
To examine the handgrip strength measured with the Jamar handheld dynamometer.
次要结局
- Change in cognitive status at 12 weeks based on the Mini Mental State Examination (MMSE)(12 weeks)
- Psychological status based on the Geriatric Depression Scale (GDS-15)(At baseline (as part of the identification of frailty))
- Change in psychological status at 12 weeks based on the Geriatric Depression Scale (GDS-15)(12 weeks)
- Endurance/Balance/Coordination(At baseline (as part of the identification of frailty))
- Change in endurance/Balance/Coordination at 12 weeks(12 weeks)
- Change in nutritional status at 12 weeks based on the Mini Nutritional Assessement (MNA)(12 weeks)
- Change in physical status/Comorbidities at 12 weeks based on the intake of medications(12 weeks)
- Nutritional status based on the Mini Nutritional Assessement (MNA)(At baseline (as part of the identification of frailty))
- Cognitive status based on the Mini Mental State Examination (MMSE)(At baseline (as part of the identification of frailty))
- Physical status/Comorbidities based on the intake of medications(At baseline (as part of the identification of frailty))
研究者
Dominique Hansen
Professor
Hasselt University