Clinical trial NCT01504737: Rehabilitation in Aortic Stenosis Patients
Official title: Rehabilitation in the Form of Exercise Training in Aortic Stenosis Patients (RASP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Exercise
Physical Activity
Physiotherapy
Exercise test
Quality of Life
Aortic Valve Replacement
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2012-01-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in peak oxygen uptake
timeFrame: Before (within one week before intervention), 1 week after and 12 months after intervention
Secondary outcomes:
measure: Change in Health-related Quality of Life
timeFrame: Before (within one week before intervention), 1 week after and 12 months after intervention
measure: Change in Physical activity level
timeFrame: Before (within one week before intervention), 1 week after and 12 months after intervention
measure: Change in hs-CRP
timeFrame: Before (within one week before intervention), 1 week after and 12 months after intervention
measure: Change in NT-pro-BNP
timeFrame: Before (within one week before intervention), 1 week after and 12 months after intervention
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Heart and Medicine Center, Linköping University Hospital
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Eva Nylander, PhD
role: STUDY_DIRECTOR
References: