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

NCT02304965 | Completed

• 1 other identifier: SU-B03
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

LVAD

Outcome Measures

Primary Outcomes (1)

• Change from baseline in brachial artery smooth muscle thickness

  Unit: mm

  At baseline and after 2 months

Secondary Outcomes (4)

• Change from baseline in peak oxygen consumption

  At baseline and after 2 months

• Change from baseline in pulse pressure during rest and exercise

  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

Study Arms (1)

Daily physical activity

EXPERIMENTAL

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

Interventions

Daily physical activity BEHAVIORAL

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.

Daily physical activity

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sven Haufe, Dr.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: December 2, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 3, 2015

Record last verified: 2015-06

Locations

DE (1)