Rehabilitation in Aortic Stenosis Patients (RASP)

Linköping University (LiU)

Status: Terminated

Conditions: Aortic Valve Stenosis

Treatments: Other: Physical Activity Recommendations; Other: Aerobic Exercise Training

Study type: Interventional

Funder types: Other

Identifiers

NCT01504737

RASP

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Supervised Exercise Training

Experimental group

Description:

12 weeks of 40 min aerobic bicycle ergometer exercise 3 times per week.

Treatment:

Other: Aerobic Exercise Training

Physical Activity Recommendations

Active Comparator group

Description:

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

Treatment:

Other: Physical Activity Recommendations