Aortic Valve StenosisTAVR-PrehabNCT03107897
Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
A study testing Pre-habilitation in people with Aortic Valve Stenosis, run by WellSpan Health at 1 site in United States.
Trial summary
In this pilot study, investigators aim to identify patients undergoing TAVR who are at elevated risk for adverse clinical events due to decreased exertional capacity and physical deconditioning. Investigators aim to determine if monitored pre-procedural physical therapy is safe in these patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Pre-habilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2016to 30 Apr 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject must be ambulatory (with or without an assist device)
- Subject has severe aortic stenosis and is felt an appropriate candidate for TAVR by the Heart Team.
- Subject requires 6.0 seconds or longer to complete a 15ft walk test
- Subject must be able to move between sitting and standing without assistance from another person.
- Subject has adequate iliac and femoral arterial anatomy to allow for TAVR via transfemoral access
- Subject is 18 years of age or greater
- Subject is willing to give consent and participate in the study
Who cannot join
- Subject is incapable of following instructions
- Subject is unable to meet the minimum required physical therapy visits
- Subject has other medical conditions rendering it unsafe, in the opinion of the Principal Investigator and physical therapy staff, to perform a 6 Minute Walk Test or physical therapy conditioning prior to TAVR
- Subject has significant severe un-revascularized epicardial coronary disease.
Trial locations and contacts
1 site in 1 country.
About this study
In this pilot study, investigators aim to identify patients undergoing TAVR who are at elevated risk for adverse clinical events due to decreased exertional capacity and physical deconditioning. Investigators aim to determine if monitored pre-procedural physical therapy is safe in these patients. Lastly, investigators aim to assess the efficacy of prehabilitation
- to improve physical functioning by the time of TAVR and to sustain benefit through 30 days post-procedure; and
- to determine its effect on post-procedural length-of-stay, clinical outcomes, and quality of life.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Pre-habilitation
- Keywords
- TAVR, elevated frailty score, Transcatheter Valve Replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-habilitationOther
Eight - Twelve visits to physical therapy prior to their TAVR procedure.
| Study group | Role | What they receive |
|---|---|---|
| Pre-procedure standard of care | No intervention | No prehab prior to TAVR. |
| Prehab prior to TAVR procedure. | Active comparator | Individuals participate in prehabilitation prior to TAVR. Receives: Other: Pre-habilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity - Change in 6 Minute Walk Test (6MWT)
Measure: Does prehabilitation improve the subject's functional exercise capacity from first PT assessment to pre-procedure assessment and first PT assessment to one month post-procedure, as measured by the 6MWT?
Measured: One month post procedure
Secondary outcomes (7)
Mobility - Timed Up and Go Test (TUG)
Does prehabilitation improve the subject's mobility from first physical therapy assessment to pre-procedure assessment and first PT assessment to one month post-procedure, as measured by the TUG test?
Measured: One month
Balance - Four Square Step Test (FSST)
Does prehabilitation improve the subject's balance from first physical therapy assessment to preprocedure assessment and first PT assessment to one month post-procedure, as measured by the FSST?
Measured: One month
Discharge Disposition
Does prehabilitation make it less likely that a patient will require a higher level of care at discharge than they require prior to admission (for example, arrive from home and discharged to home)?
Measured: 24-48 hours post procedure
Length of stay in the ICU
Hours total spent in the ICU for TAVR procedure admission
Measured: TAVR procedure admission
Total hospital length of stay
Days total spent in the hospital for TAVR procedure admission
Measured: TAVR procedure admission
Change in Quality of Life (KCCQ)
Does the Kansas City Cardiomyopathy Questionnaire score change from the first physical therapy assessment to one month post-procedure?
Measured: One month
30 day readmission
Does the subject have a 30 day re-admission post-procedure?
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start17 Aug 2016
- Primary completion9 Aug 2020
- Study completion30 Apr 2021
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparing individuals who have prehabilitation prior to their TAVR procedure with those that do not.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Harvey, WellSpan Health
- Investigators
- James Harvey, MD, Principal investigator, Wellspan York Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107897
- Sponsor's protocol ID
- TAVR Prehab
- Acronym
- TAVR-Prehab
- Status last verified
- Jun 2023
- First submitted
- 7 Mar 2017
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data defined in the protocol will be collected during trial participation and entered in a secured Electronic Data Capturing System. All data shared or copied shared will only occur after complete deidentification. Participant data will be made available for Annual Data Safety Management Board (DSMB) committee review. The Study Protocol, Informed Consent Form, and applicable Case Report Forms will be available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT03107897
- Acronym / sponsor ID
- TAVR-Prehab / TAVR Prehab
- Conditions
- Aortic Valve Stenosis
- Keywords
- TAVR, elevated frailty score, Transcatheter Valve Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Study start
- 17 Aug 2016 (actual)
- Primary completion
- 9 Aug 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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.
In this pilot study, investigators aim to identify patients undergoing TAVR who are at elevated risk for adverse clinical events due to decreased exertional capacity and physical deconditioning. Investigators aim to determine if monitored pre-procedural physical therapy is safe in these patients. Lastly, investigators aim to assess the efficacy of prehabilitation
- to improve physical functioning by the time of TAVR and to sustain benefit through 30 days post-procedure; and
- to determine its effect on post-procedural length-of-stay, clinical outcomes, and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparing individuals who have prehabilitation prior to their TAVR procedure with those that do not.
| Arm | Type | Receives |
|---|---|---|
| Pre-procedure standard of care | No intervention | –No prehab prior to TAVR. |
| Prehab prior to TAVR procedure. | Active comparator | Other: Pre-habilitationIndividuals participate in prehabilitation prior to TAVR. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must be ambulatory (with or without an assist device)
- Subject has severe aortic stenosis and is felt an appropriate candidate for TAVR by the Heart Team.
- Subject requires 6.0 seconds or longer to complete a 15ft walk test
- Subject must be able to move between sitting and standing without assistance from another person.
- Subject has adequate iliac and femoral arterial anatomy to allow for TAVR via transfemoral access
Key exclusion criteria (4 listed)
- Subject is incapable of following instructions
- Subject is unable to meet the minimum required physical therapy visits
- Subject has other medical conditions rendering it unsafe, in the opinion of the Principal Investigator and physical therapy staff, to perform a 6 Minute Walk Test or physical therapy conditioning prior to TAVR
- Subject has significant severe un-revascularized epicardial coronary disease.
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 |
|---|---|---|
| Pre-habilitationEight - Twelve visits to physical therapy prior to their TAVR procedure. | Other | Prehab prior to TAVR procedure. |
Primary outcome
Functional exercise capacity - Change in 6 Minute Walk Test (6MWT)
Time frame: One month post procedure
Measure: Does prehabilitation improve the subject's functional exercise capacity from first PT assessment to pre-procedure assessment and first PT assessment to one month post-procedure, as measured by the 6MWT?
7 secondary outcomes
Mobility - Timed Up and Go Test (TUG)
Time frame: One month
Balance - Four Square Step Test (FSST)
Time frame: One month
Discharge Disposition
Time frame: 24-48 hours post procedure
Length of stay in the ICU
Time frame: TAVR procedure admission
Total hospital length of stay
Time frame: TAVR procedure admission
Change in Quality of Life (KCCQ)
Time frame: One month
30 day readmission
Time frame: 30 days post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: Yes. All individual participant data defined in the protocol will be collected during trial participation and entered in a secured Electronic Data Capturing System. All data shared or copied shared will only occur after complete deidentification. Participant data will be made available for Annual Data Safety Management Board (DSMB) committee review. The Study Protocol, Informed Consent Form, and applicable Case Report Forms will be available.
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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.
James Harvey, MD principal investigator
Wellspan York Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-habilitation in people with Aortic Valve Stenosis, run by WellSpan Health at 1 site in United States.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 9 Jun 2023. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional exercise capacity - Change in 6 Minute Walk Test (6MWT) (time frame: One month post procedure). 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 9 Jun 2023.