A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement (ACTIVE AFTER TAVR): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 10
- 主要终点
- Average Daily Steps
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Phase 1 - Starts after the TAVR procedure and prior to discharge
- •Stroke during or immediately after the TAVR procedure prior to discharge
- •Inability to walk
- •Non-English speaking (because the mobile app and CAT questionnaires are only in English)
- •Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments. These limitations may include, but are not limited to: blindness, neuropathy, severe tremor or disabling motor deficit, cognitive impairment (documentation of dementia in the medical record), or illiteracy.
- •Unwillingness or inability of the subject to provide informed consent for Phase 1 (no LARs allowed)
- •Planned discharge from hospital to skilled nursing or rehabilitation facility
- •Phases 2 and 3 - Starts at 30 day post-TAVR follow-up visit
- •All exclusion criteria from Phase 1 apply
- •Stroke during Phase 1
- •Residing in a skilled nursing facility at the 30 day post-TAVR follow-up visit
- •Patients with unreliable use of the iPad mobile app or Fitbit during Phase 1 (e.g. not wearing the Fitbit at least 10 waking hours a day for at least 5 days a week)
- •Unwillingness or inability of the subject to provide informed consent for Phases 2/3 (no LARs allowed)
结局指标
主要结局
Average Daily Steps
时间窗: Randomization to 6 weeks
Average daily steps over the intervention period
Short Physical Performance Battery score
时间窗: 6 week value, adjusted for baseline value
Combination of gait speed, balance test, and chair-to-stand test at the end of the intervention
Quality of Life as measured with the KCCQ Overall Summary Score
时间窗: 6 week value, adjusted for baseline value
KCCQ overall summary score
次要结局
- Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form(Randomization to 6 weeks)
- Daily Active Minutes of Moderate to High Intensity(6 weeks post baseline to end of study)
- Global Physical Health(6 weeks post baseline to end of study)
- Average number of hours per day with 250 or more steps(Randomization to 6 weeks)
- 5 meter gait time at the end of the intervention period(Randomization to 6 weeks)
- Chair Sit to Stand Test(6 week value, adjusted for baseline value)
- Balance Test Score at the end of the intervention period(Randomization to 6 weeks)
- 6 minute walk(6 week value, adjusted for baseline value)
- Handgrip(6 week value, adjusted for baseline value)
- Dyspnea as assessed by the NIH PROMIS computerized adaptive test(Randomization to 6 weeks)
- KCCQ Overall Summary Score(6 weeks post baseline to end of study)
- Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form(Randomization to 6 weeks)
- Physical Function as assessed by the NIH PROMIS computerized adaptive test(Randomization to 6 weeks)
- Depression as assessed by the NIH PROMIS computerized adaptive test(Randomization to 6 weeks)
- Fatigue as assessed by the NIH PROMIS computerized adaptive test(Randomization to 6 weeks)
- Daily Active Minutes (total)(6 weeks post baseline to end of study)
- Daily Steps(6 weeks post baseline to end of study)
- Daily Sedentary Minutes(6 weeks post baseline to end of study)
- Sedentary Minutes(Randomization to 6 weeks)
- Global Mental Health(6 weeks post baseline to end of study)
研究者
Brian Lindman
Associate Professor
Vanderbilt University Medical Center