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临床试验/NCT06998498
NCT06998498进行中(未招募)不适用

Prehabilitation for Aortic Aneurysm Surgery: Proof-of-concept Trial

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年10月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
10
试验地点
1
主要终点
Intervention feasibility

研究概览

简要总结

This is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the Ready for Recovery program, a 6-week collaborative care intervention to help prepare individuals for repair of aortic aneurysms.

详细描述

This is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the Ready for Recovery program. Ready for Recovery is a 6-week collaborative care program to prepare individuals for surgical procedures to repair an aortic aneurysm. Participants will speak with a study trainer on the phone each week and will set goals related to physical activity, a healthy diet, and inspiratory muscle training. They also will be given resources to reduce stress, treat anxiety and depression (if present), and stop smoking, and the study team will make recommendations regarding medication adjustments to reduce complications after surgery. The primary outcome is feasibility (measured by percentage of phone sessions completed). Secondary outcomes include acceptability (measured by weekly 0-10 utility ratings) and preliminary impact on functional, psychological, and health behavior outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • •Adults undergoing elective aortic aneurysm repair (open or endovascular)

排除标准

  • •Cognitive disturbance
  • •Current pregnancy or plan to become pregnant prior to surgery
  • •Inability to write/speak fluently in English

研究组 & 干预措施

Ready for Recovery

Experimental

Participants in this arm will receive the Ready for Recovery intervention.

干预措施: Ready for Recovery (Behavioral)

结局指标

主要结局

Intervention feasibility

时间窗: Weekly over 6 weeks

Percentage of intervention phone sessions completed

次要结局

  • Feasibility of data collection(Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge)
  • Utility of the Ready for Recovery program(6 weeks)
  • Change in physical function (PROMIS PF-20)(Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Celano

Associate Director, Cardiac Psychiatry Research Program

Massachusetts General Hospital

研究点 (1)

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