Clinical Trial: Rehabilitation in Aortic Stenosis Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Rehabilitation in the Form of Exercise Training in Aortic Stenosis Patients (RASP)

Brief Summary:

SURVEY OF THE FIELD Aortic stenosis (AS) is the most common valve disease and increasing due to a growing elderly population. The therapy is aortic valve replacement (AVR). Studies on postoperative rehabilitation of AS pts are scarce. In the few studies available, a mix of valve diseases is presented without considering the differences in pathophysiology and the training regimes are not clearly described.

PURPOSE, AIMS & HYPOTHESIS The investigators purpose is to evaluate whether a supervised cardiac rehabilitation program improves the objective physical capacity and quality of life (QoL) of patients after AVR due to AS, and compare this to patients training by their own. The investigators hypothesize that supervised exercise training may be a more efficient way of rehabilitating these patients.

DESIGN This is a controlled randomized clinical trial comparing 12 weeks of supervised exercise training 3 times per week to home-based training based upon public health recommendations of minimum level of physical activity.

SIGNIFICANCE & IMPLEMENTATION Positive results would support that an organized program of exercise training improves physical capacity and QoL in AS patients following AVR with potential benefit for both patients and society.


Detailed Summary:
Sponsor: Linkoeping University

Current Primary Outcome: Change in peak oxygen uptake [ Time Frame: Before (within one week before intervention), 1 week after and 12 months after intervention ]

Physical capacity measured with cardiopulmonary exercise testing (CPET) on bicycle ergometer.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Health-related Quality of Life [ Time Frame: Before (within one week before intervention), 1 week after and 12 months after intervention ]
    Short-form 36, version 2
  • Change in Physical activity level [ Time Frame: Before (within one week before intervention), 1 week after and 12 months after intervention ]
    PAL - Physical activity level, measured with International Physical Activity Questionnary (IPAQ)
  • Change in hs-CRP [ Time Frame: Before (within one week before intervention), 1 week after and 12 months after intervention ]
  • Change in NT-pro-BNP [ Time Frame: Before (within one week before intervention), 1 week after and 12 months after intervention ]


Original Secondary Outcome: Same as current

Information By: Linkoeping University

Dates:
Date Received: January 2, 2012
Date Started: September 2011
Date Completion: June 2018
Last Updated: September 6, 2016
Last Verified: September 2016