Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study is being performed in patients who have undergone transcatheter aortic valve replacement (TAVR) for aortic stenosis. The goal is to obtain pilot and feasibility data on a novel post-procedure rehabilitation strategy, including a daily activity goal using a fitness tracking device (Fitbit Alta HR) and in-home resistance training exercises targeting muscles related to activities of daily living. We will evaluate the effect of these interventions on physical performance and several quality of life domains.
The study will be conducted in three phases. Subjects who have been treated commercially with TAVR with a SAPIEN 3 valve and are being discharged to home will be eligible for Phase 1. Once consented prior to discharge, patients will complete the KCCQ, PROMIS Questionnaires, 5m walk, chair stand, and handgrip tests. During phase 1, all subjects will have a Fitbit and answer quality of life questions on the iPad about their activities and quality of life. After 30 days, the subject will return to complete the PROMIS Questionnaires, 5m walk, chair stand, balance tests, and handgrip tests, as well as a KCCQ. If the subject has consistently provided data throughout Phase 1, they will be asked to continue on to Phases 2 and 3 and complete a 6 minute walk test at this baseline visit. For Phase 2, subjects will be randomized to one of two arms. In one arm, they will have a daily activity goal and resistance exercises; in the other arm, there will not be a daily activity goal and no resistance exercises given. After 6 weeks, the subject will return to complete the 5m walk, 6 minute walk test, chair stand, balance tests, and handgrip tests, PROMIS Questionnaires, as well as a KCCQ. Five months after enrollment into Phase 2, subjects will be given a Fitbit to track their daily activity for 1 week (Phase 3). They will also complete a KCCQ, PROMIS Questionnaires, and end of study questionnaire.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Resistance Exercise and No Activity Goal Arm | Active Comparator | Blinded use of Fitbit with no daily activity goal and no resistance exercises |
|
| Resistance Exercise and Activity Goal Arm | Experimental | Unblinded use of Fitbit with a daily activity goal (steps per day) and resistance exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily Activity Goal | Behavioral | Patients are given a tailored daily activity goal in terms of steps per day for which to aim. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Steps | Average daily steps over the intervention period | Randomization to 6 weeks |
| Short Physical Performance Battery score | Combination of gait speed, balance test, and chair-to-stand test at the end of the intervention | 6 week value, adjusted for baseline value |
| Quality of Life as measured with the KCCQ Overall Summary Score | KCCQ overall summary score | 6 week value, adjusted for baseline value |
| Measure | Description | Time Frame |
|---|---|---|
| 5 meter gait time at the end of the intervention period | 5 meter gait time at the end of the intervention period, adjusted for baseline | Randomization to 6 weeks |
| Chair Sit to Stand Test | Time to complete 5 chair stands |
Not provided
Inclusion Criteria:
Phase 1 - Starts after the TAVR procedure and prior to discharge • Patients treated commercially with TAVR with a SAPIEN 3 valve
Phases 2 and 3 - Starts at 30 day post-TAVR follow-up visit
• Patients enrolled in Phase 1
Exclusion Criteria:
Phase 1 - Starts after the TAVR procedure and prior to discharge
Phases 2 and 3 - Starts at 30 day post-TAVR follow-up visit
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian R Lindman, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dartmouth-Hitchcock Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34048509 | Background | Lindman BR, Gillam LD, Coylewright M, Welt FGP, Elmariah S, Smith SA, McKeel DA, Jackson N, Mukerjee K, Cloud H, Hanna N, Purpura J, Ellis H, Martinez V, Selberg AM, Huang S, Harrell FE Jr. Effect of a pragmatic home-based mobile health exercise intervention after transcatheter aortic valve replacement: a randomized pilot trial. Eur Heart J Digit Health. 2021 Feb 4;2(1):90-103. doi: 10.1093/ehjdh/ztab007. eCollection 2021 Mar. | |
| 33962483 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Resistance Exercises | Behavioral | Patients will instructed to perform 3 different resistance exercises targeting muscles pertinent to activities of daily living on 6 out of 7 days a week. |
|
|
| Daily Activity Recording | Behavioral | A Fitbit will be worn by all participants to record daily activity. |
|
| 6 week value, adjusted for baseline value |
| Balance Test Score at the end of the intervention period | Balance Test Score at the end of the intervention period, adjusted for baseline | Randomization to 6 weeks |
| 6 minute walk | 6 minute walk distance at the end of the intervention period | 6 week value, adjusted for baseline value |
| Handgrip | Handgrip strength | 6 week value, adjusted for baseline value |
| Average number of hours per day with 250 or more steps | Average number of hours per day with 250 or more steps over the intervention period | Randomization to 6 weeks |
| Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form | Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period | Randomization to 6 weeks |
| Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form | Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period | Randomization to 6 weeks |
| Physical Function as assessed by the NIH PROMIS computerized adaptive test | Physical Function as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline | Randomization to 6 weeks |
| Depression as assessed by the NIH PROMIS computerized adaptive test | Depression as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline | Randomization to 6 weeks |
| Fatigue as assessed by the NIH PROMIS computerized adaptive test | Fatigue as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline | Randomization to 6 weeks |
| Dyspnea as assessed by the NIH PROMIS computerized adaptive test | Dyspnea as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline | Randomization to 6 weeks |
| Daily Active Minutes (total) | Average daily active minutes (total) | Randomization to 6 weeks |
| Daily Active Minutes of Moderate to High Intensity | Average daily minutes of moderate to high intensity | Randomization to 6 weeks |
| Sedentary Minutes | Average daily sedentary minutes | Randomization to 6 weeks |
| Daily Steps | Average daily steps | 6 weeks post baseline to end of study |
| Daily Active Minutes (total) | Average daily active minutes (total) | 6 weeks post baseline to end of study |
| Daily Active Minutes of Moderate to High Intensity | Average daily active minutes of moderate to high intensity | 6 weeks post baseline to end of study |
| Daily Sedentary Minutes | Average daily sedentary minutes | 6 weeks post baseline to end of study |
| KCCQ Overall Summary Score | KCCQ overall summary score, adjusted for baseline | 6 weeks post baseline to end of study |
| Global Physical Health | Global physical health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline | 6 weeks post baseline to end of study |
| Global Mental Health | Global mental health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline | 6 weeks post baseline to end of study |
| Lebanon |
| New Hampshire |
| 03756 |
| United States |
| Atlantic Health - Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Derived |
| Abraham 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. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D001519 | Behavior |
Not provided
Not provided