Rehabilitation in Aortic Stenosis Patients (RASP)
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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) |
- 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.
- 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:
|
|
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 |
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| Contact: Kristofer Hedman, BSc | kristofer.hedman@liu.se | |
| Contact: Sabina Borg, BSc | sabina.borg@lio.se |
| 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 | |
| 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 May 23, 2013