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Rehabilitation in Aortic Stenosis Patients (RASP)

Primary Purpose

Aortic Valve Stenosis

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Aerobic Exercise Training
Physical Activity Recommendations
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Exercise, Physical Activity, Physiotherapy, Exercise test, Quality of Life, Aortic Valve Replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Heart and Medicine Center, Linköping University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Supervised Exercise Training

Physical Activity Recommendations

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in peak oxygen uptake
Physical capacity measured with cardiopulmonary exercise testing (CPET) on bicycle ergometer.

Secondary Outcome Measures

Change in Health-related Quality of Life
Short-form 36, version 2
Change in Physical activity level
PAL - Physical activity level, measured with International Physical Activity Questionnary (IPAQ)
Change in hs-CRP
Change in NT-pro-BNP

Full Information

First Posted
January 2, 2012
Last Updated
October 16, 2017
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT01504737
Brief Title
Rehabilitation in Aortic Stenosis Patients
Acronym
RASP
Official Title
Rehabilitation in the Form of Exercise Training in Aortic Stenosis Patients (RASP)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow inclusion rate, failure to recruit a priori determined no of patients.
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Exercise, Physical Activity, Physiotherapy, Exercise test, Quality of Life, Aortic Valve Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised Exercise Training
Arm Type
Experimental
Arm Description
12 weeks of 40 min aerobic bicycle ergometer exercise 3 times per week.
Arm Title
Physical Activity Recommendations
Arm Type
Active Comparator
Arm Description
Written and verbal information on minimal level of physical activity recommended.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Training
Other Intervention Name(s)
Physiotherapy, Physical activity
Intervention Description
12 weeks of endurance training, 40 minutes, 3 times per week on ergometer bicycle.
Intervention Type
Other
Intervention Name(s)
Physical Activity Recommendations
Other Intervention Name(s)
Exercise
Intervention Description
Written and verbal information on minimal level of physical activity recommended.
Primary Outcome Measure Information:
Title
Change in peak oxygen uptake
Description
Physical capacity measured with cardiopulmonary exercise testing (CPET) on bicycle ergometer.
Time Frame
Before (within one week before intervention), 1 week after and 12 months after intervention
Secondary Outcome Measure Information:
Title
Change in Health-related Quality of Life
Description
Short-form 36, version 2
Time Frame
Before (within one week before intervention), 1 week after and 12 months after intervention
Title
Change in Physical activity level
Description
PAL - Physical activity level, measured with International Physical Activity Questionnary (IPAQ)
Time Frame
Before (within one week before intervention), 1 week after and 12 months after intervention
Title
Change in hs-CRP
Time Frame
Before (within one week before intervention), 1 week after and 12 months after intervention
Title
Change in NT-pro-BNP
Time Frame
Before (within one week before intervention), 1 week after and 12 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Nylander, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Study Director
Facility Information:
Facility Name
Heart and Medicine Center, Linköping University Hospital
City
Linköping
State/Province
Östergötland
Country
Sweden

12. IPD Sharing Statement

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Rehabilitation in Aortic Stenosis Patients

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