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Rehabilitation in Aortic Stenosis Patients (RASP)

This study has been terminated.
(Slow inclusion rate, failure to recruit a priori determined no of patients.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01504737
First Posted: January 5, 2012
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kristofer Hedman, Linkoeping University
  Purpose

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.


Condition Intervention
Aortic Valve Stenosis Other: Aerobic Exercise Training Other: Physical Activity Recommendations

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rehabilitation in the Form of Exercise Training in Aortic Stenosis Patients (RASP)

Resource links provided by NLM:


Further study details as provided by Kristofer Hedman, Linkoeping University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: September 2011
Study Completion Date: September 1, 2017
Primary Completion Date: September 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supervised Exercise Training
12 weeks of 40 min aerobic bicycle ergometer exercise 3 times per week.
Other: Aerobic Exercise Training
12 weeks of endurance training, 40 minutes, 3 times per week on ergometer bicycle.
Other Names:
  • Physiotherapy
  • Physical activity
Active Comparator: Physical Activity Recommendations
Written and verbal information on minimal level of physical activity recommended.
Other: Physical Activity Recommendations
Written and verbal information on minimal level of physical activity recommended.
Other Name: Exercise

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective surgery with aortic valve replacement for aortic stenosis at the thoracic surgery department at Linköping University hospital, Linköping.
  • Geographical residence no further from hospital than permitting visit to Supervised Exercise Training 3 times per week

Exclusion Criteria:

  • Any concommitant heart disease
  • Other surgical intervention at time of valve replacement
  • Age under 18 years
  • Symptomatic lung disease
  • Any disability or disease hampering participation in exercise training
  • Cannot communicate with spoken Swedish
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504737


Locations
Sweden
Heart and Medicine Center, Linköping University Hospital
Linköping, Östergötland, Sweden
Sponsors and Collaborators
Linkoeping University
Investigators
Study Director: Eva Nylander, PhD Linkoeping University
  More Information

Responsible Party: Kristofer Hedman, Principal Investigator, BSc, Physiotherapist, PhD-student, Linkoeping University
ClinicalTrials.gov Identifier: NCT01504737     History of Changes
Other Study ID Numbers: RASP
First Submitted: January 2, 2012
First Posted: January 5, 2012
Last Update Posted: October 17, 2017
Last Verified: October 2017

Keywords provided by Kristofer Hedman, Linkoeping University:
Exercise
Physical Activity
Physiotherapy
Exercise test
Quality of Life
Aortic Valve Replacement

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction