Activity at Pulse Pressure Above an Individual Threshold in Patients With LVAD
- Conditions
- Heart Failure
- Interventions
- Behavioral: Daily physical activity
- Registration Number
- NCT02304965
- Lead Sponsor
- Hannover Medical School
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 7
- age 45 to 65
- men
- time since cfLVAD implantation > 3 months and < 6 months
- low pulse pressure at rest, (no pulsatility)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Daily physical activity 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.
- Primary Outcome Measures
Name Time Method Change from baseline in brachial artery smooth muscle thickness At baseline and after 2 months Unit: mm
- Secondary Outcome Measures
Name Time Method Change from baseline in peak oxygen consumption At baseline and after 2 months Unit: ml/min/kg
Change from baseline in pulse pressure during rest and exercise At baseline and after 2 months Unit: mm/Hg
Change from baseline in daily physical activity At baseline, after week 3, week 6, and after 2 months Unit: Steps per day assessed with a wearable activity device
Change from baseline in quality of life questionnaire (SF-36) At baseline and after 2 months Unit: points
Trial Locations
- Locations (1)
Hannover Medical School
🇩🇪Hannover, Lower Saxony, Germany