Rehabilitation in Aortic Stenosis Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Other: Aerobic Exercise Training
* Other: Physical Activity Recommendations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised Exercise Training<br>12 weeks of 40 min aerobic bicycle ergometer exercise 3 times per week. | Other: Aerobic Exercise Training<br>* 12 weeks of endurance training, 40 minutes, 3 times per week on ergometer bicycle.<br>* Other names: Physical activity;|
| Active Comparator: Physical Activity Recommendations<br>Written and verbal information on minimal level of physical activity recommended. | Other: Physical Activity Recommendations<br>* Written and verbal information on minimal level of physical activity recommended.<br>* Other names: Exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Change in hs-CRP |  | Before (within one week before intervention), 1 week after and 12 months after intervention | 
| Change in NT-pro-BNP |  | Before (within one week before intervention), 1 week after and 12 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Physical Activity, Physiotherapy, Exercise test, Quality of Life, Aortic Valve Replacement