Rehabilitation in Aortic Stenosis Patients (RASP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Linkoeping University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kristofer Hedman, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01504737
First received: January 2, 2012
Last updated: January 3, 2012
Last verified: January 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in NT-pro-BNP [ Time Frame: Before (within one week before intervention), 1 week after and 12 months after intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504737

Contacts
Contact: Kristofer Hedman, BSc kristofer.hedman@liu.se
Contact: Sabina Borg, BSc sabina.borg@lio.se

Locations
Sweden
Heart and Medicine Center, Linköping University Hospital Recruiting
Linköping, Östergötland, Sweden
Contact: Kristofer Hedman, PhD-student       kristofer.hedman@liu.se   
Principal Investigator: Kristofer Hedman, BSc         
Principal Investigator: Sabina Borg, BSc         
Sponsors and Collaborators
Linkoeping University
Investigators
Study Director: Eva Nylander, PhD Linkoeping University
  More Information

No publications provided

Responsible Party: Kristofer Hedman, Principal Investigator, BSc, Physiotherapist, PhD-student, Linkoeping University
ClinicalTrials.gov Identifier: NCT01504737     History of Changes
Other Study ID Numbers: RASP
Study First Received: January 2, 2012
Last Updated: January 3, 2012
Health Authority: Sweden: The National Board of Health and Welfare

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

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

ClinicalTrials.gov processed this record on April 22, 2014