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Rehabilitation in Aortic Stenosis Patients

NCT ID: NCT01504737

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2017-09-01

Brief Summary

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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

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Conditions

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Aortic Valve Stenosis

Keywords

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Exercise Physical Activity Physiotherapy Exercise test Quality of Life Aortic Valve Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supervised Exercise Training

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

Group Type EXPERIMENTAL

Aerobic Exercise Training

Intervention Type OTHER

12 weeks of endurance training, 40 minutes, 3 times per week on ergometer bicycle.

Physical Activity Recommendations

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

Group Type ACTIVE_COMPARATOR

Physical Activity Recommendations

Intervention Type OTHER

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

Interventions

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Aerobic Exercise Training

12 weeks of endurance training, 40 minutes, 3 times per week on ergometer bicycle.

Intervention Type OTHER

Physical Activity Recommendations

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

Intervention Type OTHER

Other Intervention Names

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Physiotherapy Physical activity Exercise

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kristofer Hedman

Principal Investigator, BSc, Physiotherapist, PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Nylander, PhD

Role: STUDY_DIRECTOR

Linkoeping University

Locations

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Heart and Medicine Center, Linköping University Hospital

Linköping, Östergötland County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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RASP

Identifier Type: -

Identifier Source: org_study_id