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

Daily Physical Activity at Pulse Pressure Above an Individual Threshold in Patients With Continuous Flow Left Ventricular Assist Devices - a Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Daily physical activity

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Hannover, Lower Saxony, Germany, 30625
      • Hannover Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Daily physical activity; A combination of walking (> 10.000 steps per day) and cycling on a stationary bicycle at home at an individual intensity. For the activity walking patients need to walk at a certain speed (e.g. 3 km/h) in order to be in the range of pulsatility as obtained from their pre-training treadmill test. For cycling a defined power in watt and duration will be given to each patient as defined from the pre-training cycling test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in brachial artery smooth muscle thickness	Unit: mm	At baseline and after 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in peak oxygen consumption	Unit: ml/min/kg	At baseline and after 2 months
Change from baseline in pulse pressure during rest and exercise	Unit: mm/Hg	At baseline and after 2 months
Change from baseline in daily physical activity	Unit: Steps per day assessed with a wearable activity device	At baseline, after week 3, week 6, and after 2 months
Change from baseline in quality of life questionnaire (SF-36)	Unit: points	At baseline and after 2 months

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Sven Haufe, Dr., Hannover Medical School

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: December 1, 2014
• First Posted (Estimate): December 2, 2014

Study Record Updates

• Last Update Posted (Estimate): September 3, 2015
• Last Update Submitted That Met QC Criteria: September 2, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: LVAD
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SU-B03