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Rehabilitation in Aortic Stenosis Patients

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01504737
Acronym
RASP
Enrollment
12
Registered
2012-01-05
Start date
2011-09-30
Completion date
2017-09-01
Last updated
2017-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

Exercise, Physical Activity, Physiotherapy, Exercise test, Quality of Life, Aortic Valve Replacement

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.

Interventions

OTHERAerobic Exercise Training

12 weeks of endurance training, 40 minutes, 3 times per week on ergometer bicycle.

Written and verbal information on minimal level of physical activity recommended.

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in peak oxygen uptakeBefore (within one week before intervention), 1 week after and 12 months after interventionPhysical capacity measured with cardiopulmonary exercise testing (CPET) on bicycle ergometer.

Secondary

MeasureTime frameDescription
Change in Health-related Quality of LifeBefore (within one week before intervention), 1 week after and 12 months after interventionShort-form 36, version 2
Change in Physical activity levelBefore (within one week before intervention), 1 week after and 12 months after interventionPAL - Physical activity level, measured with International Physical Activity Questionnary (IPAQ)
Change in hs-CRPBefore (within one week before intervention), 1 week after and 12 months after intervention
Change in NT-pro-BNPBefore (within one week before intervention), 1 week after and 12 months after intervention

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026