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Slow inclusion rate, failure to recruit a priori determined no of patients.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised Exercise Training | Experimental | 12 weeks of 40 min aerobic bicycle ergometer exercise 3 times per week. |
|
| Physical Activity Recommendations | Active Comparator | Written and verbal information on minimal level of physical activity recommended. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise Training | Other | 12 weeks of endurance training, 40 minutes, 3 times per week on ergometer bicycle. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Nylander, PhD | Linkoeping University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart and Medicine Center, Linköping University Hospital | Linköping | Östergötland County | Sweden |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D009043 | Motor Activity |
| D009068 | Movement |
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| Physical Activity Recommendations | Other | Written and verbal information on minimal level of physical activity recommended. |
|
|
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 |
| D014694 |
| Ventricular Outflow Obstruction |
| D001519 | Behavior |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |