Brief Title
Rehabilitation in Aortic Stenosis Patients
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.
Study Type
Interventional
Primary Outcome
Change in peak oxygen uptake
Secondary Outcome
Change in Health-related Quality of Life
Condition
Aortic Valve Stenosis
Intervention
Aerobic Exercise Training
Study Arms / Comparison Groups
Supervised Exercise Training
Description: 12 weeks of 40 min aerobic bicycle ergometer exercise 3 times per week.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
12
Start Date
September 2011
Completion Date
September 1, 2017
Primary Completion Date
September 1, 2017
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Eva Nylander, PhD, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT01504737
Organization ID
RASP
Responsible Party
Principal Investigator
Study Sponsor
Linkoeping University
Study Sponsor
Eva Nylander, PhD, Study Director, Linkoeping University
Verification Date
October 2017