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临床试验/NCT03739879
NCT03739879已完成不适用

Effectivity of Inspiratory Muscle Trainer in the Chronic Obstructive Pulmonary Disease Rehabilitation Program

Indonesia University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年9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
15
试验地点
2
主要终点
Health status

研究概览

简要总结

This study aimed to reveal the role of inspiratory muscles exercise using Inspiratory Muscle Trainer (IMT), which is a form of weight training. The pre- and post study of this experiment were conducted in chronic obstructive pulmonary disease (COPD) outpatient clinic during the period of September 2017 until April 2018. Patients were recruited by consecutive sampling. Inclusion criteria were stable COPD patient with The Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria A-D, who has never received prior exercise for pulmonary rehabilitation, and willing to participate in the study. The exclusion criteria included any problem with extremities and cardiovascular disease. Patients underwent an interview about their medical history, tested spirometry using CareFusion®, and the inspiratory muscle strength was assessed using Micro RPM CareFusion®. The St George Respiratory Questionnaire (SGRQ) was used to assess the health status and the 6-Minute Walking Test (6MWT) was conducted to assess functional capacity. Subject exercised using inspiratory muscle trainer (Philips Respironic®) for eight weeks.

详细描述

Intervention is given using Inspiratory Muscle Trainer Philips Respironic®. Impact on inspiratory muscles strength, health status, and functional capacity are observed. Muscle strength is evaluated using Micro RPM (Respiratory Pressure Meter) Carefusion®. Health status is evaluated using St. George's Respiratory Questionnaire (SGRQ), while functional capacity is evaluated by the 6-Minute Walk Test (6MWT).

Patients were recruited by consecutive sampling. This study was granted ethical approval from the Institutional Review Board (IRB) of the Faculty of Medicine Universitas Indonesia Subjects exercised using inspiratory muscle trainer (Philips Respironic®) for 8 weeks. Inspiratory muscles strength (Maximal Inspiratory Pressure, MIP) and 6MWT were done at the beginning for basic data and were re-evaluated during the second, fourth, sixth and eighth week (last week). Questionnaire (SGRQ) was done at the initial and end of research.

Training dose with IMT was determined by inspiratory muscle strength result and adjusted in every evaluation visit. The subject was expected to do exercise twice daily for 15 minutes each session with 30-70% intensity from determined MIP score. Exercise is monitored and noted in a logbook.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • stable COPD patient with GOLD criteria A-D,
  • never got exercise for pulmonary rehabilitation before,
  • willing to participate in the study by signing the written informed consent.

排除标准

  • any problem with extremities,
  • cardiovascular disease

研究组 & 干预措施

Inspiratory muscle training (IMT)

Experimental

Subjects exercised using inspiratory muscle trainer (Philips Respironic®) for 8 weeks. Training dose with IMT was determined by inspiratory muscle strength result and adjusted in every evaluation visit. The subject was expected to do exercise twice daily for 15 minutes each session with 30-70% intensity from determined MIP score. Exercise is monitored and noted in a logbook.

干预措施: Inspiratory Muscle Trainer Philips Respironics (Device)

结局指标

主要结局

Health status

时间窗: Eighth week

Health status was evaluated using St George Respiratory Questionnaire (SGRQ) SGRQ was a questionnaire designed to measure health impairment in asthmatic and COPD patients. It consists of three parts. First part is symptom, followed by activity and impact. Every question has its own score. The least is zero and the highest is 100. Score is calculated by dividing total score with maximum score for that component and translated into percentage.

Functional capacity

时间窗: Eighth week

This outcome was determined by 6-minutes walking test

Inspiratory muscles strength

时间窗: Eighth week

This outcome was determined by maximal inspiratory pressure (MIP)

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

Fariz Nurwidya

Lecturer

Indonesia University

研究点 (2)

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