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临床试验/NCT03876834
NCT03876834已完成不适用

Influence of Respiratory Training on Functional Capacity in Patients With Leukemia

Cairo University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年3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
已完成
入组人数
40
试验地点
2
主要终点
Maximum voluntary ventilation

研究概览

简要总结

Forty male leukemic patients receiving chemotherapy were selected from National Cancer Institute, They were randomly assigned into two groups. Group (A) included 30 patients who were trained by Inspiratory muscle trainer for 4 weeks ;5 sessions/week and Group (B) included 10 patients as a control group.

The following measures were taken before and after the study period : Maximum voluntary ventilation(MVV) , 2 min walk test, FACT-G questionnaire

详细描述

Forty male leukemic patients receiving chemotherapy for at least one cycle and their mean ages 37.1 ± 4.89 years.The patients were selected from National Cancer Institute, Cairo ( inpatient ward). The study lasted from March 2018 to June 2018. Patients were randomly assigned into two groups.Group A (30 patients) who received inspiratory muscles training for 4 successive weeks, 5 sessions/week; and Group B (10 patients) acted as a control group on chemotherapy only. Data obtained from both groups regarding (MVV), 2 min walk test and Quality of life questionnaire (FACT-G) were statistically analyzed and compared

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • male patient with age ranges from 30-50 years
  • All patients were leukemic receiving chemotherapy for at least one cycle as a treatment of malignant tumor
  • All patients were hemodynamically stable
  • All patients were ambulant

排除标准

  • lung cancer
  • History of any pulmonary disease.
  • Metastasis of lungs, ribs, mediastinal structure
  • Pulmonary pathology(e.g acute respiratory distress syndrome or exacerbation of chronic obstructive pulmonary disease)
  • ruptured ear drum or any other condition of the ear
  • High peak airway pressure (barotraumas)
  • patients with marked elevated left ventricular end diastolic volume and pressure
  • patients with worsening heart failure signs and symptoms

研究组 & 干预措施

study group (group A)

Experimental

Group (A) included 30 leukemic patients receiving chemotherapy in addition to training by inspiratory muscle trainer(IMT) for 4 weeks, 5 sessions /week

干预措施: respiratory training (Other)

control group (B)

No Intervention

Group (B) included 10 leukemic patients receiving chemotherapy only

结局指标

主要结局

Maximum voluntary ventilation

时间窗: change from baseline maximum voluntary ventilation at 4 weeks

It was performed by breathing deeply and rapidly for 10 to 15 seconds using spirometer

2 min walk test

时间窗: change from baseline 2 min walk test at 4 weeks

Each patient was asked to cover as much ground as possible over 2 minutes

FACT-G questionnaire

时间窗: change from baseline FACT-G questionnaire at 4 weeks

27 questions with four domains assessing physical well being,social well being, emotional well being and functional wellbeing

次要结局

未报告次要终点

研究者

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

Heba Ahmed Ali Abdeen

Assistant professor

Cairo University

研究点 (2)

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