Rehabilitation in Aortic Stenosis Patients

Not Applicable

Terminated

• Conditions: Aortic Valve Stenosis
• Interventions: Other: Aerobic Exercise Training; Other: Physical Activity Recommendations

• Registration Number: NCT01504737
• Lead Sponsor: Linkoeping University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-05
• Primary Completion: 2017-09-01
• Study Completion: 2017-09-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised Exercise Training	Aerobic Exercise Training	12 weeks of 40 min aerobic bicycle ergometer exercise 3 times per week.
Physical Activity Recommendations	Physical Activity Recommendations	Written and verbal information on minimal level of physical activity recommended.

Primary Outcome Measures

Name	Time	Method
Change in peak oxygen uptake	Before (within one week before intervention), 1 week after and 12 months after intervention	Physical capacity measured with cardiopulmonary exercise testing (CPET) on bicycle ergometer.

Secondary Outcome Measures

Name	Time	Method
Change in Health-related Quality of Life	Before (within one week before intervention), 1 week after and 12 months after intervention	Short-form 36, version 2
Change in Physical activity level	Before (within one week before intervention), 1 week after and 12 months after intervention	PAL - Physical activity level, measured with International Physical Activity Questionnary (IPAQ)
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

Trial Locations

Locations (1)

Heart and Medicine Center, Linköping University Hospital; 🇸🇪 Linköping, Östergötland, Sweden