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临床试验/NCT03890250
NCT03890250已完成不适用

Investigation of the Effectiveness of Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis

Biruni University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年3月20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
22
试验地点
1
主要终点
Assessment of endurance capacity

研究概览

简要总结

Pulmonary rehabilitation should be initiated and lifelong at the time of diagnosis for patients with IPF. However, the symptoms of the disease and its progression limit clinical options in terms of participation and sustainability in rehabilitation programs. For this purpose, patients with IPF need physiotherapy and rehabilitation options that will not increase the symptoms associated with exercise and contribute to the program in the long term. Neuromuscular electrical stimulation (NMES) is a rehabilitation option that can be applied to specific muscle groups without the ventilator and cardiac load especially in patients who can not actively exercise or have decreased muscle strength. In adult patients with an advanced disease characterized by reduced muscle strength, the use of NMES in addition to aerobic exercise programs is recommended as part of rehabilitation programs. In the literature, no studies investigating the efficacy of NMES have been found in individuals with IPF or interstitial lung disease. NMES application in addition to aerobic exercise seems to be a reasonable option when considering the symptoms of patients with IPF and the progression of the disease. The aim of this project is to investigate the efficacy of NMES in addition to aerobic exercise in IPF patients based on evidence by objective methods.

详细描述

Idiopathic pulmonary fibrosis (IPF) is a progressive, fibrotic interstitial lung disease characterized by progressive dyspnoea, reduced exercise capacity, quality of life, and classified as a rare disease. With the increase in medical treatment options, the progression of the disease slows down. Increased time of survival has increased the need for pulmonary rehabilitation programs that have been shown to be effective in patients' exercise capacity, participation in daily living activities, and improvement in the quality of life. Patients with IPF have been shown to be able to improve dyspnoea, fatigue, exercise capacity, daily living activities and quality of life with home-based or supervised breathing, posture, strengthening and aerobic/endurance exercise programs.

Pulmonary rehabilitation should be initiated and lifelong at the time of diagnosis for patients with IPF. However, the symptoms of the disease and its progression limit clinical options in terms of participation and sustainability in rehabilitation programs. For this purpose, patients with IPF need physiotherapy and rehabilitation options that will not increase the symptoms associated with exercise and contribute to the program in the long term. Neuromuscular electrical stimulation (NMES) is a rehabilitation option that can be applied to specific muscle groups without the ventilator and cardiac load especially in patients who can not actively exercise or have decreased muscle strength. In adult patients with an advanced disease characterized by reduced muscle strength, the use of NMES in addition to aerobic exercise programs is recommended as part of rehabilitation programs. In the literature, no studies investigating the efficacy of NMES have been found in individuals with IPF or interstitial lung disease. NMES application in addition to aerobic exercise seems to be a reasonable option when considering the symptoms of patients with IPF and the progression of the disease. The aim of this project is to investigate the efficacy of NMES in addition to aerobic exercise in IPF patients based on evidence by objective methods.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The assessor will be blind to the randomization and the investigator will be blind to the results of assessments.

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A diagnosis of IPF according to current ATS / ERS guidelines has been followed by a pulmonary specialist for at least 6 months
  • Patients who are clinically stable, have no flare or infection.

排除标准

  • Orthopedic and neurological problems that may interfere with exercise training,
  • Modification of medical treatment during the study,
  • Unstable cardiac diseases,
  • Participation in another pulmonary rehabilitation program over the past 12 months,
  • Inadequate cooperation,
  • Contraindications for the application of neuromuscular electrical stimulation (risk of embolism, neoplasm, infection in the region of application, pacemaker, sensory defect).

结局指标

主要结局

Assessment of endurance capacity

时间窗: 2 months

Endurance capacity will be assessed with "Shuttle Endurance Walking test". The number of shuttles will be recorded and maximum VO2 will be calculated.

Assessment of exercise capacity

时间窗: 2 months

Exercise capacity will be assessed with 6-minutes walk test. The six minutes walking distance will be recorded in "metres".

次要结局

  • Assessment of activities of daily living(2 months)
  • Assessment of peripheral muscle strength(2 months)
  • Assessment of fatigue(2 months)
  • Assessment of quality of life: "Saint George Quality of Life Survey(2 months)

研究者

发起方
Biruni University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Buket AKINCI

Assistant Proffesor

Biruni University

研究点 (1)

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