Robotic Assisted Rehabilitation for Heart Failure Patients and Patients After Cardiac Surgery

NCT02146196 | Unknown DMC

• 1 other identifier: ZH_2011_0119
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Robotic assisted gait therapy with the Lokomat® as a new method for rehabilitation in advanced heart failure and after cardiac surgery.

Conditions

Heart Failure; Post Cardiac Surgery

Keywords

Heart failure; robotic assisted gait therapy

Outcome Measures

Primary Outcomes (8)

• Deep sternal wound infections

  Occurence of deep sternal wound infections due to training, only in patients after cardiac surgery

  12 weeks after hospital discharge

• Changes in VO2 (maximal oxygen uptak in ml/(kg*min))

  Change in maximal oxygen uptake during spiroergometry due to training, only in heart failure patients

  After four weeks robot-assisted training with the Lokomat®

• Changes in BNP

  Change in brain natriuretic peptide due to training, measured in mg/ml. Only in heart failure patients.

  After four weeks robot-assisted training with the Lokomat®

• Changes in strength measurement of the musculus quadriceps

  isometric strength of the musculus quadriceps measured in kilopond

  After four weeks robotic assisted training with the Lokomat®. In the postcardiotomy group after one week robot-assisted training

• Changes in CRP (C- reactive protein)

  Change in C- reactive protein, due to training, measured in mg/ml. Only in heart failure patients.

  After four weeks robot-assisted training with the Lokomat®

• Changes in IL 6 (interleukin 6)

  Change in interleukin 6(measured in mg/ml), due to training. Only in heart failure patients.

  After four weeks robot-assisted training with the Lokomat®

• Changes in SF 36

  Questionaire (SF 36- short form 36 of health survey) to assess changes in quality of life due to the training. Only in heart failure patients

  After four weeks robot-assisted training with the Lokomat®

• Changes in walking distance (in meters) in 6 minute walk test (MWT)

  6 minute walk test to assess changes in walking distance after training period, only in patients after cardiac surgery

  After one week robot-assisted training with the Lokomat®

Study Arms (2)

Heart failure, robotic assisted training

EXPERIMENTAL

4 weeks robotic assisted training with the Lokomat®

Device: 4 weeks robotic assisted training with the Lokomat®

Post cardiac surgery

EXPERIMENTAL

One week robotic assisted gait training with the Lokomat®

Device: One week robotic assisted gait training with the Lokomat®

Interventions

4 weeks robotic assisted training with the Lokomat® DEVICE

During a prespecified time period (4weeks) a three times weekly robotic assisted gait training during 30-45 minutes. Strength training, interval training and endurance training are possible.

Heart failure, robotic assisted training

One week robotic assisted gait training with the Lokomat® DEVICE

During a prespecified time period (1week) a three times weekly robotic assisted gait training during 10-40 minutes. Strength training, interval training and endurance training are possible

Post cardiac surgery

Eligibility Criteria

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

You may qualify if:

• Heart failure patients:
• stable heart failure (over 3 months, NYHA 2, NYHA 3)
• Left ventricular ejection fraction less than 45% postoperative patients:
• possibility to walk at least 50m on the ground floor

You may not qualify if:

• weight \>100kg

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (2)

• Schoenrath F, Markendorf S, Brauchlin AE, Frank M, Wilhelm MJ, Saleh L, Riener R, Schmied CM, Falk V. Robot-assisted training for heart failure patients - a small pilot study. Acta Cardiol. 2015 Dec;70(6):665-71. doi: 10.2143/AC.70.6.3120178.

  PMID: 26717214 DERIVED

• Schoenrath F, Markendorf S, Brauchlin AE, Seifert B, Wilhelm MJ, Czerny M, Riener R, Falk V, Schmied CM. Robot-Assisted Training Early After Cardiac Surgery. J Card Surg. 2015 Jul;30(7):574-80. doi: 10.1111/jocs.12576. Epub 2015 May 22.

  PMID: 25998717 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Volkmar Falk, MD

  University of Zurich

  STUDY DIRECTOR

Central Study Contacts

Felix Schoenrath, MD

CONTACT

0041442553298; felix_schoenrath@gmx.de

Michael Stader

CONTACT

0041442553298; michael.stader@usz.ch

Study Design

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

Study Record Dates

• First Submitted: May 11, 2014
• First Posted: May 23, 2014
• Study Start: February 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 30, 2014

Record last verified: 2014-10

Locations

CH (1)