Frail ElderlySTEPNCT02766075
A STEP for Patients Prior to Undergoing TAVR: A Pilot Study
A study testing Supervised TAVR Exercise Program in people with Frail Elderly and Aortic Valve Stenosis, run by OSF Healthcare System at 1 site in United States.
Trial summary
The aim of this pilot study is to establish whether a Supervised TAVR Exercise Program (STEP) can safely improve the frailty status in patients with symptomatic severe aortic valve stenosis prior to undergoing transcatheter aortic valve replacement (TAVR). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Frail Elderly, Aortic Valve Stenosis
- What is being tested?
- Supervised TAVR Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Feb 2018
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients scheduled to undergo first-time elective TAVR
Who cannot join
- Vulnerable populations including prisoners, pregnant females and patients less than 18 years age.
- Patients with history of unstable angina, myocardial infarction, or decompensated heart failure in the week prior to screening
- Patients with physical limitations (i.e. debilitating stroke, amputation, unable to complete initial screening frailty profile)
- Patients with advanced dementia or cognitive deficits (i.e. unable to follow instructions of initial screening frailty profile)
- Exercise-induced arrhythmias
Trial locations and contacts
1 site in 1 country.
United States1 site
OSF St. Francis Medical Center
Peoria, Illinois, 61630
About this study
Official title: A Supervised TAVR Exercise Program (STEP) for Patients Prior to Undergoing Transcatheter Aortic Valve Replacement (TAVR): A Pilot Study
The aim of this pilot study is to establish whether a Supervised TAVR Exercise Program (STEP) can safely improve the frailty status in patients with symptomatic severe aortic valve stenosis prior to undergoing transcatheter aortic valve replacement (TAVR).
Read the detailed description
TAVR is an approved alternative therapy for patients with severe aortic valve stenosis who are deemed inoperable or high-risk for surgical aortic valve replacement (SAVR). Despite a very high procedural success rate (>95%), mortality rates after TAVR at 1- and 2-year follow-up remain ≥25% and ≥34%, respectively. It is becoming increasingly evident that frailty, as a clinical syndrome, has a large impact on this long term mortality. In a study by Green, et al. frailty status was independently associated with increased 1-year mortality (OR=3.5) after TAVR. The investigators' own retrospective analysis showed that impaired mobility and malnutrition were significantly associated with a longer hospital length of stay (5 days vs. 3 days), and increased total cost (on average, an additional $10,000 per patient). Given the phenotype of frailty is characterized by reductions in muscle mass, strength, endurance and activity level, a STEP is ideally suited to counteract these impairments. This pilot study aims to establish whether a STEP can safely improve the frailty score in patients with symptomatic severe aortic valve stenosis prior to undergoing TAVR.
This single-center pilot study will be conducted in partnership between Heart Care Midwest (HCMW), OSF St. Francis Medical Center (OSF SFMC), and University of Illinois College of Medicine at Peoria (UICOMP). UICOMP Center of Outcomes Research will provide analytical support. The study will be funded by an operational research grant from OSF SFMC.
- Conditions
- Frail Elderly, Aortic Valve Stenosis
- Being tested
- Supervised TAVR Exercise Program
- Keywords
- Transcatheter Aortic Valve Disease, Supervised TAVR Exercise Program
- 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.
Supervised TAVR Exercise ProgramBehavioural
Individualized exercise program designed and implemented by licensed physical therapy clinicians in three 60-minute sessions per week for four weeks. Upon randomization, subjects in the Intervention Group will undergo an initial Dynamic Gait \& Balance Assessment by a licensed physical therapy clinician. The physical therapy clinician will use this assessment to design and implement an individualized STEP in three 60-minute sessions per week for four weeks. Subjects will proceed with their pre-TAVR testing in conjunction with the STEP sessions.
| Study group | Role | What they receive |
|---|---|---|
| Supervised TAVR Exercise Program (STEP) | Experimental | Subjects in the experimental arm will participate in an individualized 4-week STEP prior to undergoing TAVR. All subjects will undergo serial frailty assessments by a blinded research assistant at baseline, pre-TAVR, and 30-days post-TAVR. Receives: Behavioral: Supervised TAVR Exercise Program |
| Standard of Care | No intervention | Subjects in the no intervention arm will proceed with their TAVR after a minimum 4 weeks without an exercise intervention. All subjects will undergo serial frailty assessments by a blinded research assistant at baseline, pre-TAVR, and 30-days post-TAVR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Frailty Score from Baseline to post-STEP
Measured: Baseline, 6-weeks
Secondary outcomes (9)
Adverse Events
Measured: 6-weeks
Change in Frailty Score from Baseline to 30-days post-TAVR
Measured: Baseline, 30-days post-TAVR
Change in Gait Speed (5-Meter Walk Test) from Baseline to post-STEP
Measured: Baseline, 6-weeks
Change in Gait Speed (5-Meter Walk Test) from Baseline to 30-days post-TAVR
Measured: Baseline, 30-days post-TAVR
Change in Grip Strength (Dynamometer) from Baseline to post-STEP
Measured: Baseline, 6-weeks
Change in Grip Strength (Dynamometer) from Baseline to 30-days post-TAVR
Measured: Baseline, 30-days post-TAVR
Change in Independent Activity (Katz Activities of Daily Living Survey) from Baseline to post-STEP
Measured: Baseline, 6-weeks
Change in Independent Activity (Katz Activities of Daily Living Survey) from Baseline to to 30-days post-TAVR
Measured: Baseline, 30-days post-TAVR
Change in Malnutrition (Serum Albumin Level) from Baseline to 30-days post-TAVR
Measured: Baseline, 30-days post-TAVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startMay 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Collaborators
- HeartCare Midwest, University of Illinois College of Medicine at Peoria
- Responsible party
- Sponsor
- Investigators
- Jay N Patel, MD, Principal investigator, OSF Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766075
- Sponsor's protocol ID
- 837484
- Acronym
- STEP
- Status last verified
- Apr 2017
- First submitted
- 28 Apr 2016
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Supervised TAVR Exercise Program (STEP) for Patients Prior to Undergoing Transcatheter Aortic Valve Replacement (TAVR): A Pilot Study
- ClinicalTrials.gov ID
- NCT02766075
- Acronym / sponsor ID
- STEP / 837484
- Conditions
- Frail Elderly, Aortic Valve Stenosis
- Keywords
- Transcatheter Aortic Valve Disease, Supervised TAVR Exercise Program
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Collaborators
- HeartCare Midwest, University of Illinois College of Medicine at Peoria
- Study start
- May 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 9 May 2016 (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.
The aim of this pilot study is to establish whether a Supervised TAVR Exercise Program (STEP) can safely improve the frailty status in patients with symptomatic severe aortic valve stenosis prior to undergoing transcatheter aortic valve replacement (TAVR).
Detailed description
TAVR is an approved alternative therapy for patients with severe aortic valve stenosis who are deemed inoperable or high-risk for surgical aortic valve replacement (SAVR). Despite a very high procedural success rate (>95%), mortality rates after TAVR at 1- and 2-year follow-up remain ≥25% and ≥34%, respectively. It is becoming increasingly evident that frailty, as a clinical syndrome, has a large impact on this long term mortality. In a study by Green, et al. frailty status was independently associated with increased 1-year mortality (OR=3.5) after TAVR. The investigators' own retrospective analysis showed that impaired mobility and malnutrition were significantly associated with a longer hospital length of stay (5 days vs. 3 days), and increased total cost (on average, an additional $10,000 per patient). Given the phenotype of frailty is characterized by reductions in muscle mass, strength, endurance and activity level, a STEP is ideally suited to counteract these impairments. This pilot study aims to establish whether a STEP can safely improve the frailty score in patients with symptomatic severe aortic valve stenosis prior to undergoing TAVR.
This single-center pilot study will be conducted in partnership between Heart Care Midwest (HCMW), OSF St. Francis Medical Center (OSF SFMC), and University of Illinois College of Medicine at Peoria (UICOMP). UICOMP Center of Outcomes Research will provide analytical support. The study will be funded by an operational research grant from OSF SFMC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised TAVR Exercise Program (STEP) | Experimental | Behavioral: Supervised TAVR Exercise ProgramSubjects in the experimental arm will participate in an individualized 4-week STEP prior to undergoing TAVR. All subjects will undergo serial frailty assessments by a blinded research assistant at baseline, pre-TAVR, and 30-days post-TAVR. |
| Standard of Care | No intervention | –Subjects in the no intervention arm will proceed with their TAVR after a minimum 4 weeks without an exercise intervention. All subjects will undergo serial frailty assessments by a blinded research assistant at baseline, pre-TAVR, and 30-days post-TAVR. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients scheduled to undergo first-time elective TAVR
Key exclusion criteria (5 listed)
- Vulnerable populations including prisoners, pregnant females and patients less than 18 years age.
- Patients with history of unstable angina, myocardial infarction, or decompensated heart failure in the week prior to screening
- Patients with physical limitations (i.e. debilitating stroke, amputation, unable to complete initial screening frailty profile)
- Patients with advanced dementia or cognitive deficits (i.e. unable to follow instructions of initial screening frailty profile)
- Exercise-induced arrhythmias
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 |
|---|---|---|
| Supervised TAVR Exercise ProgramIndividualized exercise program designed and implemented by licensed physical therapy clinicians in three 60-minute sessions per week for four weeks. Upon randomization, subjects in the Intervention Group will undergo an initial Dynamic Gait \& Balance Assessment by a licensed physical therapy clinician. The physical therapy clinician will use this assessment to design and implement an individualized STEP in three 60-minute sessions per week for four weeks. Subjects will proceed with their pre-TAVR testing in conjunction with the STEP sessions. | Behavioural | Supervised TAVR Exercise Program (STEP) |
Primary outcome
Change in Frailty Score from Baseline to post-STEP
Time frame: Baseline, 6-weeks
9 secondary outcomes
Adverse Events
Time frame: 6-weeks
Change in Frailty Score from Baseline to 30-days post-TAVR
Time frame: Baseline, 30-days post-TAVR
Change in Gait Speed (5-Meter Walk Test) from Baseline to post-STEP
Time frame: Baseline, 6-weeks
Change in Gait Speed (5-Meter Walk Test) from Baseline to 30-days post-TAVR
Time frame: Baseline, 30-days post-TAVR
Change in Grip Strength (Dynamometer) from Baseline to post-STEP
Time frame: Baseline, 6-weeks
Change in Grip Strength (Dynamometer) from Baseline to 30-days post-TAVR
Time frame: Baseline, 30-days post-TAVR
Change in Independent Activity (Katz Activities of Daily Living Survey) from Baseline to post-STEP
Time frame: Baseline, 6-weeks
Change in Independent Activity (Katz Activities of Daily Living Survey) from Baseline to to 30-days post-TAVR
Time frame: Baseline, 30-days post-TAVR
Change in Malnutrition (Serum Albumin Level) from Baseline to 30-days post-TAVR
Time frame: Baseline, 30-days post-TAVR
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Jay N Patel, MD principal investigator
OSF Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised TAVR Exercise Program in people with Frail Elderly and Aortic Valve Stenosis, run by OSF Healthcare System 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 1 inclusion and 5 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 12 Apr 2018. 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 was stopped early (reason given: Low enrollment). 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 Frailty Score from Baseline to post-STEP (time frame: Baseline, 6-weeks). 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 12 Apr 2018.