Multi-Component Prehabilitation Program for High-Risk Older Adults Undergoing Major Elective Surgery: A Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of the Prehabilitation Program
研究概览
简要总结
The purpose of this pilot study is to assess the feasibility of delivering a multicomponent prehabilitation and measuring patient-centered outcomes in older adults undergoing major surgery.
详细描述
We will assess the feasibility of delivering a multicomponent prehabilitation, which consists of exercise (supervised by physical therapist), nutritional intervention (nutritional supplement and group education), meditation (group class), and cognitive behavioral intervention over 3-4 weeks before major elective abdominal, gynecological oncologic, urologic surgery, and cardiovascular procedures. We will also measure patient-centered outcomes (Patient-Reported Outcomes Measurement Information System) at 30 and 90 days after surgery. The target enrollment is 30 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient is scheduled to have a gastrointestinal, gynecological oncologic, urologic, and cardiovascular procedure
- •Age 70 years+
- •Age 65 years+ AND high risk per surgeon's clinical judgment
- •Patient provides an informed e-consent or remote consent
排除标准
- •Surgery is scheduled less than 21 days
- •Patient is considered an inappropriate candidate per the surgeon's assessment
- •Non-English speaking
- •Major cognitive impairment
- •Patients with chronic kidney disease stage 3 or higher will be excluded from receiving protein supplement of the prehabilitation program
研究组 & 干预措施
Prehabilitation
This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.
干预措施: Exercise (Behavioral)
Prehabilitation
This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.
干预措施: Nutrition (Behavioral)
Prehabilitation
This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.
干预措施: Meditation (Behavioral)
Prehabilitation
This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.
干预措施: Cognitive Behavioral Intervention (Behavioral)
结局指标
主要结局
Feasibility of the Prehabilitation Program
时间窗: Post-intervention (up to 4 weeks)
Measurement: Percentage of patients to whom we can deliver an adequate dose (≥50% of the planned sessions) of the 3 core interventions: physical therapy (≥4/8 sessions), nutrition (≥2/3-4 sessions), and meditation (≥2/3-4 sessions). Range: 0-100% (higher values indicate higher feasibility).
次要结局
- Change in 5-chair Stand Test Time(Between pre-intervention baseline and post-intervention (up to 4 weeks))
- Change in Dominant Handgrip Strength(Between pre-intervention baseline and post-intervention (up to 4 weeks))
- Adherence to Exercise(Post-intervention (up to 4 weeks))
- Adherence to Nutrition(Post-intervention (up to 4 weeks))
- Adherence to Meditation(Post-intervention (up to 4 weeks))
- Adverse Events(Between pre-intervention baseline and post-intervention (up to 4 weeks))
研究者
Dae Hyun Kim
Associate Professor of Medicine
Beth Israel Deaconess Medical Center