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临床试验/NCT03099629
NCT03099629已完成不适用

Efficacy of Inspiratory Muscle Training on Respiratory Performance in Patients With Esophageal Cancer Receiving Combined Modality Therapy

Mackay Memorial Hospital1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
1
主要终点
Changes of diaphragmatic surface electromyography (EMGdi)

研究概览

简要总结

The purpose of this study is to investigate the effectiveness of inspiratory muscle training (IMT) on respiratory performance in patients with esophageal cancer during combined modality therapy.

详细描述

Background and Purpose: Incidence rates of esophageal cancer remain high in Eastern Asia. In 2012, esophageal cancer was the 9th leading cause of cancer deaths in Taiwan. Whether surgical resection is possible, combined modality therapy is usually required for the treatment of esophageal cancer. In clinical observation, patients underwent combined modality therapy usually demonstrated respiratory muscle dysfunction which might further impair physical activity and quality of life. The purpose of this study is to investigate the effectiveness of inspiratory muscle training (IMT) on respiratory performance in patients with esophageal cancer during combined modality therapy.

Methods: This is a prospective interventional study design. A total of 45 patients with newly diagnosed esophageal cancer will be recruited from the Mackay Memorial Hospital. All tests will be performed at baseline (prior to cancer treatment), weekly during treatment, prior to surgery, and one month after surgery. Tests will include demographic data collection, respiratory muscle performance (maximal inspiratory and expiratory pressure tests combined with diaphragmatic surface electromyography, and pulmonary functional test), dyspnea, and the functional exercise test (6-min walk test). IMT will start with an intensity of 30% of maximal inspiratory pressure, 15 times/set, 3 sets/day, 7 days/week and training will continue until surgery is scheduled or 2 weeks after the completion of treatment if surgery is not suitable. Repeated measure ANOVA will be used for analyzing difference of parameters among various time points.

Clinical relevance: The results of this study will help to better understand the clinical beneficial effects (e.g., better functional capacity) of an added inspiratory muscle training during combined modality therapy in patients with esophageal cancer.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed primary esophageal cancer, aged more than 20 years, communicate without difficulty.

排除标准

  • inability to perform inspiratory muscle training, the presence of unstable angina or myocardial infarction in recently one month, cannot cooperate with training protocols, and pregnancy.

结局指标

主要结局

Changes of diaphragmatic surface electromyography (EMGdi)

时间窗: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)

Change from baseline EMGdi at the end of each week's CCRT treatment

Changes of forced vital capacity (FVC)

时间窗: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)

Change from baseline FVC at the end of each week's CCRT treatment

Changes of maximal inspiratory pressure (MIP)

时间窗: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)

Change from baseline MIP at the end of each week's CCRT treatment

Changes of maximal expiratory pressure (MEP)

时间窗: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)

Change from baseline MEP at the end of each week's CCRT treatment

Changes of forced expiratory volume in one second (FEV1)

时间窗: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)

Change from baseline FEV1 at the end of each week's CCRT treatment

次要结局

  • Changes of dyspnea using Modified Borg Dyspnea score(Baseline and weekly during CCRT treatment (for a total of 4-5 weeks))
  • Changes of functional exercise capacity using 6-minute walking distance(Baseline and weekly during CCRT treatment (for a total of 4-5 weeks))

研究者

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

Yu-Jen Chen

VS. Division of Radiation Oncology, Department of Radiology

Mackay Memorial Hospital

研究点 (1)

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