Rehabilitation in Aortic Stenosis Patients (RASP)

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

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.

Study Overview

• Status: Terminated
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Other: Aerobic Exercise Training; Other: Physical Activity Recommendations

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Östergötland
    • Linköping, Östergötland, Sweden
      • Heart and Medicine Center, Linköping University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Physical activity; Physiotherapy
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 Names: Exercise

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Study Director: Eva Nylander, PhD, Linkoeping University

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): September 1, 2017

Study Registration Dates

• First Submitted: January 2, 2012
• First Submitted That Met QC Criteria: January 3, 2012
• First Posted (ESTIMATE): January 5, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Quality of Life; Aortic Valve Replacement; Physiotherapy; Exercise test
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: RASP