Daily Physical Activity at Pulse Pressure Above an Individual Threshold in Patients With Continuous Flow Left Ventricular Assist Devices - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change from baseline in brachial artery smooth muscle thickness
研究概览
简要总结
Pilot study in patients with continuous flow left ventricular assist device (cfLVAD) to proof the feasibility of a specific individual training at home aimed to increase pulse pressure above a predefined threshold which might attenuate the loss of arterial wall thickness.
Hypothesis:
Increasing daily physical activity near to normal (> 10.000 steps per day) with a pre-defined level of pulse pressure (intensity) is a realizable and feasible approach to investigate changes in arterial wall thickness and cardio-respiratory capacity in cfLVAD patients.
详细描述
The investigators will study 3 cfLVAD patients with low pulse pressure during work package 1 using two different exercises, treadmill and bicycle. Walking and cycling present the most commonly used physical activities which are applicable to most individuals on a daily basis. The investigators aim to demonstrate that individual changes of pulse pressure during these types of exercise can be assessed in cfLVAD patients.
In a feasibility study (work package 2) the investigator will enroll 6 cfLVAD patients to perform home-based physical activity programs including walking a defined number of steps per day with a predefined speed and cycling with a predefined power [watt] on a bicycle ergometer. The performance of the patients will be monitored over seven days using a wearable activity device.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age 45 to 65
- •time since cfLVAD implantation > 3 months and < 6 months
- •low pulse pressure at rest, (no pulsatility)
排除标准
- •musculoskeletal comorbidities restricting exercise
- •known diabetes mellitus Type 1 and 2
- •acute or chronic infections
- •coronary heart disease before cfLVAD implantation
- •no pulsatility with increasing exercise
研究组 & 干预措施
Daily physical activity
Eligible subjects will be included in the feasibility study to conduct an individualized and structured training program with defined walking and cycling on a bicycle ergometer for 2 months.
干预措施: Daily physical activity (Behavioral)
结局指标
主要结局
Change from baseline in brachial artery smooth muscle thickness
时间窗: At baseline and after 2 months
Unit: mm
次要结局
- Change from baseline in pulse pressure during rest and exercise(At baseline and after 2 months)
- Change from baseline in peak oxygen consumption(At baseline and after 2 months)
- Change from baseline in daily physical activity(At baseline, after week 3, week 6, and after 2 months)
- Change from baseline in quality of life questionnaire (SF-36)(At baseline and after 2 months)