Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Change in the Late-Life Function and Disability Instrument (LLFDI) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Exercise & Cognitive Behavioral Int.
A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.
干预措施: Exercise (Behavioral)
Exercise & Cognitive Behavioral Int.
A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.
干预措施: Cognitive behavioral interventions (Behavioral)
Exercise Alone
A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions.
干预措施: Exercise (Behavioral)
Attention Control Education Program
Participants will receive telephone-based education sessions from a study health professional.
干预措施: Attention control education program (Behavioral)
结局指标
主要结局
Change in the Late-Life Function and Disability Instrument (LLFDI) Score
时间窗: 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.
次要结局
- Change in the Short Physical Performance Battery (SPPB) Summary Score(At baseline and week 8)
- Number of Participants Who Experienced Adverse Events(At week 8)
- Change in Dominant Hand Grip Strength (kg)(At baseline and week 8)
- Change in the 2-Minute Walk Distance (Feet)(At baseline and week 8)
研究者
Dae Hyun Kim, MD, MPH, ScD
Associate Physician
Brigham and Women's Hospital