Aortic Valve Stenosis Clinical Trial
— RASPOfficial title:
Rehabilitation in the Form of Exercise Training in Aortic Stenosis Patients (RASP)
Verified date | October 2017 |
Source | Linkoeping University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 12 |
Est. completion date | September 1, 2017 |
Est. primary completion date | September 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Heart and Medicine Center, Linköping University Hospital | Linköping | Östergötland |
Lead Sponsor | Collaborator |
---|---|
Linkoeping University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in peak oxygen uptake | Physical capacity measured with cardiopulmonary exercise testing (CPET) on bicycle ergometer. | Before (within one week before intervention), 1 week after and 12 months after intervention | |
Secondary | Change in Health-related Quality of Life | Short-form 36, version 2 | Before (within one week before intervention), 1 week after and 12 months after intervention | |
Secondary | Change in Physical activity level | PAL - Physical activity level, measured with International Physical Activity Questionnary (IPAQ) | Before (within one week before intervention), 1 week after and 12 months after intervention | |
Secondary | Change in hs-CRP | Before (within one week before intervention), 1 week after and 12 months after intervention | ||
Secondary | Change in NT-pro-BNP | Before (within one week before intervention), 1 week after and 12 months after intervention |
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