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临床试验/NCT05665257
NCT05665257已完成不适用

Preoperative Inspiratory Muscle Training for Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - a Feasibility Study

Uppsala University0 个研究点目标入组 30 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
主要终点
Feasibility of preoperative inspiratory muscle training

研究概览

简要总结

The goal of this randomized controlled feasibility study was to evaluate the feasibility of preoperative inspiratory muscle training in patients undergoing surgery because of peritoneal metastases.

The main questions it aimed to answer was how feasible the intervention is regarding process and scientific feasibility as defined by Thabane et al 2010.

Participants in the intervention group were using a handheld device to increase their inspiratory muscle strength prior to surgery and researchers compared this group to a control group who were offered a sham treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

排除标准

  • Surgery scheduled less than two weeks from the date of inclusion
  • Inability to speak and understand Swedish

结局指标

主要结局

Feasibility of preoperative inspiratory muscle training

时间窗: The different outcome measures are assessed continuously during a period from inclusion until discharge from the hospital. This period varied in length (3 weeks-3 months) depending on when participants were scheduled for surgery.

Feasibility will be assessed using two domains: process and scientific feasibility. These domains include several parts such as recruitment rates, time available for training, intervention adherence, patient acceptability, pre-and postoperative respiratory muscle and lung function assessments, reproducibility of assessments, preliminary treatment effect, incidence of PPCs, and adverse events.

次要结局

未报告次要终点

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

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