Activity at Pulse Pressure Above an Individual Threshold in Patients With LVAD

Hannover Medical School (MHH)

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Daily physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT02304965

SU-B03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: Male

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 45 to 65
• men
• time since cfLVAD implantation > 3 months and < 6 months
• low pulse pressure at rest, (no pulsatility)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Daily physical activity

Experimental group

Description:

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.

Treatment:

Behavioral: Daily physical activity