CClinicalTrials.gg
TerminatedNCT01504737RASPUpdated Oct 17, 2017

Rehabilitation in Aortic Stenosis Patients

An interventional study of Aerobic Exercise Training and Physical Activity Recommendations in Aortic Valve Stenosis, sponsored by Linkoeping University. Terminated at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-17.

Sponsored by Linkoeping University · Not applicable, Interventional, and Treatment

Why this study was terminated
Slow inclusion rate, failure to recruit a priori determined no of patients.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aortic Valve Stenosis

Keywords

  • Exercise
  • Physical Activity
  • Physiotherapy
  • Exercise test
  • Quality of Life
  • Aortic Valve Replacement
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 12 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Linkoeping University is the lead sponsor of 189 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Supervised Exercise Training

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

    Other: Aerobic Exercise Training

  • Active comparator
    Physical Activity Recommendations

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

    Other: Physical Activity Recommendations

Interventions

  • OtherAerobic Exercise Training

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

    Also known as: Physiotherapy, Physical activity

  • OtherPhysical Activity Recommendations

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

    Also known as: Exercise

06

What researchers measure

Primary outcomes

  1. Change in peak oxygen uptake

    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 outcomes

  1. Change in Health-related Quality of Life

    Short-form 36, version 2

    Time frame: Before (within one week before intervention), 1 week after and 12 months after intervention

  2. Change in Physical activity level

    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

  3. Change in hs-CRP

    Time frame: Before (within one week before intervention), 1 week after and 12 months after intervention

  4. Change in NT-pro-BNP

    Time frame: Before (within one week before intervention), 1 week after and 12 months after intervention

07

Study locations

1 site
  • Heart and Medicine Center, Linköping University Hospital
    Linköping, Östergötland, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01504737
Lead sponsor
Linkoeping University
Responsible party
Kristofer Hedman (Principal Investigator, BSc, Physiotherapist, PhD-student, Linkoeping University) — Principal investigator
First posted
Jan 5, 2012
Start date
Sep 2011
Primary completion
Sep 1, 2017
Completion
Sep 1, 2017
Last update
Oct 17, 2017

Study contacts

Eva Nylander, PhD
study director · Linkoeping University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion