Aortic Valve StenosisRASPNCT01504737
Rehabilitation in Aortic Stenosis Patients
A study testing Aerobic Exercise Training and Physical Activity Recommendations in people with Aortic Valve Stenosis, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Aerobic Exercise Training and Physical Activity Recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2011to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Heart and Medicine Center, Linköping University Hospital
Linköping, Östergötland County
About this study
Official title: 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.
Read more
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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Aerobic Exercise Training, Physical Activity Recommendations
- Keywords
- Exercise, Physical Activity, Physiotherapy, Exercise test, Quality of Life, Aortic Valve Replacement
- Medical subject headings
- Aortic Valve Stenosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingOther
Also called Physiotherapy, Physical activity
12 weeks of endurance training, 40 minutes, 3 times per week on ergometer bicycle.
Physical Activity RecommendationsOther
Also called Exercise
Written and verbal information on minimal level of physical activity recommended.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Training | Experimental | 12 weeks of 40 min aerobic bicycle ergometer exercise 3 times per week. Receives: Other: Aerobic Exercise Training |
| Physical Activity Recommendations | Active comparator | Written and verbal information on minimal level of physical activity recommended. Receives: Other: Physical Activity Recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen uptake
Physical capacity measured with cardiopulmonary exercise testing (CPET) on bicycle ergometer.
Measured: Before (within one week before intervention), 1 week after and 12 months after intervention
Secondary outcomes (4)
Change in Health-related Quality of Life
Short-form 36, version 2
Measured: 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)
Measured: Before (within one week before intervention), 1 week after and 12 months after intervention
Change in hs-CRP
Measured: Before (within one week before intervention), 1 week after and 12 months after intervention
Change in NT-pro-BNP
Measured: Before (within one week before intervention), 1 week after and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startSep 2011
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Why it stopped: Slow inclusion rate, failure to recruit a priori determined no of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kristofer Hedman, Linkoeping University
- Investigators
- Eva Nylander, PhD, Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504737
- Sponsor's protocol ID
- RASP
- Acronym
- RASP
- Status last verified
- Oct 2017
- First submitted
- 2 Jan 2012
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation in the Form of Exercise Training in Aortic Stenosis Patients (RASP)
- ClinicalTrials.gov ID
- NCT01504737
- Acronym / sponsor ID
- RASP / RASP
- Conditions
- Aortic Valve Stenosis
- Keywords
- Exercise, Physical Activity, Physiotherapy, Exercise test, Quality of Life, Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow inclusion rate, failure to recruit a priori determined no of patients.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Sep 2011
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 5 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Training | Experimental | Other: Aerobic Exercise Training12 weeks of 40 min aerobic bicycle ergometer exercise 3 times per week. |
| Physical Activity Recommendations | Active comparator | Other: Physical Activity RecommendationsWritten and verbal information on minimal level of physical activity recommended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise TrainingAlso: Physiotherapy, Physical activity12 weeks of endurance training, 40 minutes, 3 times per week on ergometer bicycle. | Other | Supervised Exercise Training |
| Physical Activity RecommendationsAlso: ExerciseWritten and verbal information on minimal level of physical activity recommended. | Other | Physical Activity Recommendations |
Primary outcome
Change in peak oxygen uptake
Time frame: 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.
4 secondary outcomes
Change in Health-related Quality of Life
Time frame: Before (within one week before intervention), 1 week after and 12 months after intervention
Change in Physical activity level
Time frame: Before (within one week before intervention), 1 week after and 12 months after intervention
Change in hs-CRP
Time frame: Before (within one week before intervention), 1 week after and 12 months after intervention
Change in NT-pro-BNP
Time frame: Before (within one week before intervention), 1 week after and 12 months after intervention
Results and safety
The study was stopped early (reason given: Slow inclusion rate, failure to recruit a priori determined no of patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Nylander, PhD study director
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Training and Physical Activity Recommendations in people with Aortic Valve Stenosis, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow inclusion rate, failure to recruit a priori determined no of patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak oxygen uptake (time frame: Before (within one week before intervention), 1 week after and 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.