跳至主要内容
临床试验/NCT04566172
NCT04566172撤回不适用

Preoperative Optimization to Improve Functional Status

Johns Hopkins University1 个研究点 分布在 1 个国家开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Overall Inspiratory muscle training compliance as assessed by daily logs

研究概览

简要总结

This is a pilot study to obtain preliminary information on the usability and efficacy of a pre-habilitation program. The investigators will recruit up to 100 patients.

The two specific aims of this study are to conduct an initial pilot study with the following goals:

  1. To obtain information on feasibility and utilization of the program
  2. To determine whether participation in the program improves a patient's Maximal Inspiratory Pressure

详细描述

Participants will engage in a pre-habilitation program prior to surgery at home, that includes using an inspiratory muscle training (IMT) device that will strengthen the muscles of breathing. Participants will keep a log of training. The Maximum Inspiratory Pressure will be measured at baseline and prior to surgery.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Undergoing thoracic or upper abdominal surgery with an estimated date of surgery between 2-10 weeks after enrollment
  • •Age>65 y/o

排除标准

  • •Impaired cognition that would limit participation in the program
  • •History of spontaneous pneumothorax
  • •Any other physician judgement

研究组 & 干预措施

Prehabilitation program

Experimental

Patient undergoing thoracic or upper abdominal surgery as part of their regular medical care will be approached. Participants will receive a prehabilitation program that includes an inspiratory muscle training that they will do leading up to the day of their surgery.

干预措施: Inspiratory Muscle Training (IMT) (Behavioral)

结局指标

主要结局

Overall Inspiratory muscle training compliance as assessed by daily logs

时间窗: Up to 10 Weeks

The primary outcome variable will be compliance with \>70% of inspiratory muscle training. Patients will be instructed to follow the prescribed program daily from the day consent is obtained until the day of surgery. Patients will complete a daily log of breathing exercises.

次要结局

  • Change in maximum inspiratory pressure(Baseline and on the day of surgery, up to 10 weeks from enrollment)
  • Overall Satisfaction with the Program as assessed by a likert scale(Day of Surgery, up to 10 weeks from enrollment)
  • Number of attempted inspiratory muscle training as assessed by percent days the program was attempted(Up to 10 Weeks)
  • Number of completed inspiratory muscle training as assessed by percent days with full compliance(Up to 10 Weeks)
  • Interest in Using Program for Future Surgeries as assessed by a likert scale(Day of Surgery, up to 10 weeks from enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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