Aortic StenosisTAVR-FRAILTYNCT02597985
Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis
A study testing Prehabilitation in people with Aortic Stenosis, run by Mayo Clinic at 1 site in United States.
Trial summary
Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients undergoing TAVR exhibit frailty, a syndrome associated with poor survival. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 10 Sep 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility for TAVR
- SPPB<9
- Able to exercise
- Able to come for follow-up visits
- Able to give informed consent
Who cannot join
- New York Heart Association (NYHA) Class III/IV congestive heart failure (CHF)
- Presyncope or syncope as presentation
- Acute coronary syndrome
- Unable to exercise
- Dementia
- Sustained ventricular arrhythmia
Show all 9Show fewer
- Stroke with neurological deficit
- Advanced Parkinson's
- Participated in an exercise program
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Prehabilitation to Improve Functional and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: TAVR-FRAILTY Trial
Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients undergoing TAVR exhibit frailty, a syndrome associated with poor survival. It is unknown whether interventions to improve frailty before TAVR (prehabilitation) will improve outcomes after TAVR. This study plans to evaluate whether simple cardiac exercise interventions to improve physical performance before TAVR improves outcomes after TAVR.
- Conditions
- Aortic Stenosis
- Being tested
- Prehabilitation, Usual Care
- Keywords
- Frailty
- Medical subject headings
- Aortic Valve Stenosis, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
Supervised exercise training intervention will include three sessions per week for four weeks at a Mayo Clinic system cardiac rehabilitation facility. The Rochester, Minnesota Cardiac Rehabilitation Program will provide guidance and oversight. Modes of aerobic exercise will include treadmill walking (the primary mode of training) supplemented with non-weight-bearing activities such as stationary cycling and combination arm/leg recumbent exercise (NuStep device), as needed. Intensity will be set using Borg Perceived Exertion Scale (RPE) ratings of 12-14 (somewhat hard), keeping patients below the threshold for more than mild angina.
Usual CareOther
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Active comparator | Will receive 4 weeks of supervised exercised prescription before they undergo TAVR and will monitor and record, improvement if any, in the short-term physical performance battery score Receives: Other: Prehabilitation |
| Usual care | Placebo comparator | Will receive usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Score on short physical performance battery (SPPB) test
Measured: Baseline, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startOct 2015
- Primary completion17 Jun 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandeep Singh, Mayo Clinic
- Investigators
- Mandeep Singh, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597985
- Sponsor's protocol ID
- 15-004180
- Acronym
- TAVR-FRAILTY
- Status last verified
- Dec 2021
- First submitted
- 26 Oct 2015
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation to Improve Functional and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: TAVR-FRAILTY Trial
- ClinicalTrials.gov ID
- NCT02597985
- Acronym / sponsor ID
- TAVR-FRAILTY / 15-004180
- Conditions
- Aortic Stenosis
- Keywords
- Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 5 Nov 2015 (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.
Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients undergoing TAVR exhibit frailty, a syndrome associated with poor survival. It is unknown whether interventions to improve frailty before TAVR (prehabilitation) will improve outcomes after TAVR. This study plans to evaluate whether simple cardiac exercise interventions to improve physical performance before TAVR improves outcomes after TAVR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Active comparator | Other: PrehabilitationWill receive 4 weeks of supervised exercised prescription before they undergo TAVR and will monitor and record, improvement if any, in the short-term physical performance battery score |
| Usual care | Placebo comparator | Other: Usual CareWill receive usual care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligibility for TAVR
- SPPB<9
- Able to exercise
- Able to come for follow-up visits
- Able to give informed consent
Key exclusion criteria (9 listed)
- New York Heart Association (NYHA) Class III/IV congestive heart failure (CHF)
- Presyncope or syncope as presentation
- Acute coronary syndrome
- Unable to exercise
- Dementia
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 |
|---|---|---|
| PrehabilitationSupervised exercise training intervention will include three sessions per week for four weeks at a Mayo Clinic system cardiac rehabilitation facility. The Rochester, Minnesota Cardiac Rehabilitation Program will provide guidance and oversight. Modes of aerobic exercise will include treadmill walking (the primary mode of training) supplemented with non-weight-bearing activities such as stationary cycling and combination arm/leg recumbent exercise (NuStep device), as needed. Intensity will be set using Borg Perceived Exertion Scale (RPE) ratings of 12-14 (somewhat hard), keeping patients below the threshold for more than mild angina. | Other | Prehabilitation |
| Usual Care | Other | Usual care |
Primary outcome
Change in Score on short physical performance battery (SPPB) test
Time frame: Baseline, approximately 1 year
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 23 Dec 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Human Experimental Models of Pain (HEMP)
Acute Pain
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Mandeep Singh, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Aortic Stenosis, run by Mayo Clinic 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 5 inclusion and 9 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 23 Dec 2021. 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. Some participants in this study may receive a placebo. 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?
Change in Score on short physical performance battery (SPPB) test (time frame: Baseline, approximately 1 year). 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 23 Dec 2021.