Aortic Valve StenosisREHAB-TAVRNCT02805309
Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement
A study testing Exercise and Cognitive behavioral interventions in people with Aortic Valve Stenosis, run by Brigham and Women's Hospital at 3 sites in United States.
Trial summary
Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for older adults with severe symptomatic aortic stenosis who are considered high risk for surgical aortic valve replacement. Despite symptomatic and survival benefits, many patients experience functional decline after TAVR. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Exercise and Cognitive behavioral interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2017to 6 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- Underwent transcatheter aortic valve replacement
- Lives within 20-mile radius of the recruiting site
- Plan to be discharged home
- Able to provide informed consent
Who cannot join
- Stroke or any other medical disease that precludes participation in the exercise program
- Severe cognitive impairment (Mini-Mental State Examination < 15)
- Current enrollment in another clinical trial
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02120
Hebrew SeniorLife
Boston, Massachusetts, 02131
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement: A Pilot Study
Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for older adults with severe symptomatic aortic stenosis who are considered high risk for surgical aortic valve replacement. Despite symptomatic and survival benefits, many patients experience functional decline after TAVR. This pilot study aims to test the feasibility of a home-based exercise intervention targeting endurance, strength, and balance as well as cognitive behavioral intervention to improve physical functioning and disability after TAVR.
Read the detailed description
We hypothesize that a home-based exercise program with cognitive behavioral intervention is more effective than home-based exercise alone; home-based exercise program with and without cognitive behavioral intervention is more effective than attention control educational intervention in preventing decline in physical function and disability after TAVR.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Exercise, Cognitive behavioral interventions, Attention control education program
- Keywords
- Transcatheter Aortic Valve Replacement, Exercise, Frailty, Functional Outcomes, Cognitive Behavioral Intervention
- Medical subject headings
- Aortic Valve Stenosis, Motor Activity, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.
Cognitive behavioral interventionsBehavioural
The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.
Attention control education programBehavioural
A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Exercise & Cognitive Behavioral Int. | Experimental | A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Receives: Behavioral: Exercise; Behavioral: Cognitive behavioral interventions |
| Exercise Alone | Experimental | A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Receives: Behavioral: Exercise |
| Attention Control Education Program | Active comparator | Participants will receive telephone-based education sessions from a study health professional. Receives: Behavioral: Attention control education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Late-Life Function and Disability Instrument (LLFDI) Score
The LLFDI is a validated patient-reported outcome questionnaire that measures both functional limitations (inability to perform physical tasks - Activity Limitation Domain score, range: 0-100) and disability (inability to perform major life tasks and social roles - Participation Restriction Domain score, range: 0-100). For both scales, higher values indicate better function (lower limitation or lower disability). Two domain scores are analyzed separately.
Measured: At baseline and week 8
Secondary outcomes (4)
Change in the Short Physical Performance Battery (SPPB) Summary Score
The summary score is calculated based on chair stands, walking speed, and standing balance (range: 0-12). Higher scores indicate better physical performance.
Measured: At baseline and week 8
Change in the 2-Minute Walk Distance (Feet)
The 2-minute walk distance measures endurance. A longer distance indicates better endurance.
Measured: At baseline and week 8
Change in Dominant Hand Grip Strength (kg)
Dominant hand grip strength measures upper extremity strength.
Measured: At baseline and week 8
Number of Participants Who Experienced Adverse Events
Number of participants who experience any adverse events and serious adverse events
Measured: At week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start1 Aug 2017
- Primary completion6 May 2020
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew SeniorLife, National Institute on Aging (NIA), Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Dae Hyun Kim, MD, MPH, ScD, Brigham and Women's Hospital
- Investigators
- Dae Hyun Kim, MD, MPH, ScD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805309
- Sponsor's protocol ID
- 2017P000106
- Other IDs
- P30AG031679, P30AG048785
- Acronym
- REHAB-TAVR
- Status last verified
- Jun 2021
- First submitted
- 11 Jun 2016
- Last updated
- 21 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi SM, Rapley FA, Margulis H, Laham RJ, Guibone K, Percy E, Kaneko T, Wang KY, Kim DH. Home-Based Rehabilitation After Transcatheter Aortic Valve Replacement (REHAB-TAVR): A Pilot Randomized Controlled Trial. J Am Geriatr Soc. 2025 Jun;73(6):1836-1846. doi: 10.1111/jgs.19456. Epub 2025 Apr 2.
PubMed 40171799Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
PubMed 33962483
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement: A Pilot Study
- ClinicalTrials.gov ID
- NCT02805309
- Acronym / sponsor ID
- REHAB-TAVR / 2017P000106
- Conditions
- Aortic Valve Stenosis
- Keywords
- Transcatheter Aortic Valve Replacement, Exercise, Frailty, Functional Outcomes, Cognitive Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Hebrew SeniorLife, National Institute on Aging (NIA), Beth Israel Deaconess Medical Center
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Posted 21 Jul 2021
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 minimally invasive procedure for older adults with severe symptomatic aortic stenosis who are considered high risk for surgical aortic valve replacement. Despite symptomatic and survival benefits, many patients experience functional decline after TAVR. This pilot study aims to test the feasibility of a home-based exercise intervention targeting endurance, strength, and balance as well as cognitive behavioral intervention to improve physical functioning and disability after TAVR.
Detailed description
We hypothesize that a home-based exercise program with cognitive behavioral intervention is more effective than home-based exercise alone; home-based exercise program with and without cognitive behavioral intervention is more effective than attention control educational intervention in preventing decline in physical function and disability after TAVR.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise & Cognitive Behavioral Int. | Experimental | Behavioral: Exercise, Behavioral: Cognitive behavioral interventionsA physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. |
| Exercise Alone | Experimental | Behavioral: ExerciseA physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. |
| Attention Control Education Program | Active comparator | Behavioral: Attention control education programParticipants will receive telephone-based education sessions from a study health professional. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 65 years
- Underwent transcatheter aortic valve replacement
- Lives within 20-mile radius of the recruiting site
- Plan to be discharged home
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Stroke or any other medical disease that precludes participation in the exercise program
- Severe cognitive impairment (Mini-Mental State Examination < 15)
- Current enrollment in another clinical trial
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 |
|---|---|---|
| ExerciseExercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. | Behavioural | Exercise & Cognitive Behavioral Int., Exercise Alone |
| Cognitive behavioral interventionsThe following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins. | Behavioural | Exercise & Cognitive Behavioral Int. |
| Attention control education programA health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes. | Behavioural | Attention Control Education Program |
Primary outcome
Change in the Late-Life Function and Disability Instrument (LLFDI) Score
Time frame: At baseline and week 8
The LLFDI is a validated patient-reported outcome questionnaire that measures both functional limitations (inability to perform physical tasks - Activity Limitation Domain score, range: 0-100) and disability (inability to perform major life tasks and social roles - Participation Restriction Domain score, range: 0-100). For both scales, higher values indicate better function (lower limitation or lower disability). Two domain scores are analyzed separately.
4 secondary outcomes
Change in the Short Physical Performance Battery (SPPB) Summary Score
Time frame: At baseline and week 8
Change in the 2-Minute Walk Distance (Feet)
Time frame: At baseline and week 8
Change in Dominant Hand Grip Strength (kg)
Time frame: At baseline and week 8
Number of Participants Who Experienced Adverse Events
Time frame: At week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40171799Shi SM, Rapley FA, Margulis H, Laham RJ, Guibone K, Percy E, Kaneko T, Wang KY, Kim DH. Home-Based Rehabilitation After Transcatheter Aortic Valve Replacement (REHAB-TAVR): A Pilot Randomized Controlled Trial. J Am Geriatr Soc. 2025 Jun;73(6):1836-1846. doi: 10.1111/jgs.19456. Epub 2025 Apr 2.
- Derived from this study: PubMed 33962483Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
- 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.
Dae Hyun Kim, MD, MPH, ScD principal investigator
Beth Israel Deaconess Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Cognitive behavioral interventions in people with Aortic Valve Stenosis, run by Brigham and Women's Hospital at 3 sites 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 3 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 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 21 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 the Late-Life Function and Disability Instrument (LLFDI) Score (time frame: At baseline and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02805309, which also lists 2 linked publications.
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 21 Jul 2021.