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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304965
• Other study ID #: SU-B03
• Status: Completed
• Phase: N/A
• First received: November 21, 2014
• Last updated: September 2, 2015
• Start date: November 2014
• Est. completion date: September 2015

Study information

• Verified date: June 2015
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in brachial artery smooth muscle thickness	Unit: mm	At baseline and after 2 months	No
Secondary	Change from baseline in peak oxygen consumption	Unit: ml/min/kg	At baseline and after 2 months	No
Secondary	Change from baseline in pulse pressure during rest and exercise	Unit: mm/Hg	At baseline and after 2 months	No
Secondary	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	No
Secondary	Change from baseline in quality of life questionnaire (SF-36)	Unit: points	At baseline and after 2 months	No