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临床试验/NCT04533516
NCT04533516
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Effectiveness of 12-Weeks Inspiratory Muscle Training With Manual Therapy in Patients With COPD: Randomized Controlled Study

Istinye University1 个研究点 分布在 1 个国家目标入组 40 人2020年8月29日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Chronic Obstructive Pulmonary Disease Severe
发起方
Istinye University
入组人数
40
试验地点
1
主要终点
6 minute walk test
状态
已完成
最后更新
4年前

概览

简要总结

The benefits of inspiratory muscle training(IMT) in patients with chronic obstructive pulmonary disease(COPD) were reported.But in severe COPD patients, benefit from IMT may be limited.There is need for further research in new and complementary modalities to improve IMT efficiency in severe COPD patients.Manual therapy(MT) additional over IMT may be such a new approach that has not yet been investigated in COPD.

Aims: To investigate effects of MT additional over IMT on functional capacity,respiratory muscle strength,pulmonary function,dyspnea, fatigue and quality of life in severe COPD patients.

Methods: It was a prospective single-blind randomized trial. 40 patients with COPD in Global Initiative for Chronic Obstructive Lung Disease(GOLD) stage III-IV were included. Patients were randomly assigned to receive either MT additional over IMT at 40% of maximal inspiratory pressure(MIP)(n= 20) or only IMT(n= 20) for 12 weeks. MT group received MT during 12 weeks for 40 minutes additional to IMT. Pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, functional capacity using six minute walk test, dyspnea using Modified Medical Research Council(MMRC) dyspnea scale, fatigue using fatigue severity scale and quality of life using St. George's Respiratory Questionnaire(SGRQ) were evaluated.

注册库
clinicaltrials.gov
开始日期
2020年8月29日
结束日期
2021年4月12日
最后更新
4年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Yasemin Çırak

Physiotherapist, PhD, Associate Professor

Istinye University

入排标准

入选标准

  • Clinical diagnosis of chronic obstructive pulmonary disease
  • Being clinically stable
  • Having FEV1/FVC ratio of ≤ 50% of the predicted value after bronchodilator drugs.

排除标准

  • Having an acute bronchitis,
  • Having a pneumonia,
  • Having an exacerbation of COPD,
  • Having thoracic spinal scoliosis,
  • Having substantial chest wall deformity, or acute rib or vertebral fracture.
  • Unable to perform the pulmonary function test because of cognitive or physical impairments.

结局指标

主要结局

6 minute walk test

时间窗: 12 weeks

6 minute walk test (6MWT) was applied to measure exercise capacity. The patient's heart rate, breathing frequency, and oxygen saturation were monitored with the pulse oximeter, and the values were recorded before and after the test. The distance was expressed both as metres.

respiratory muscle strength

时间窗: 12 weeks

For respiratory muscle strength, maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) were evaluated using an electronic pressure transducer. MIP was measured at residual volume, and MEP was measured from total lung capacity.

Dyspnea perception

时间窗: 12 weeks

Dyspnea perception was assessed using the modified Medical Research Council (MMRC) dyspnea scale, Levels of dyspnea are graded 0 (absence of dyspnea during strenuous exercise), to 4 (dyspnea during daily activities).

Fatigue perception

时间窗: 12 weeks

Fatigue perception was assessed with Turkish version of Fatigue Severity Scale. A high score indicates increased fatigue intensity and the maximum score of the scale is 63.

Pulmonary Function Test

时间窗: 12 weeks

Before the pulmonary function test, all subjects rested to avoid fatigue. The lung function test including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and vital capacity (VC) was performed in a seated position using a portable spirometer according to the American Thoracic Society guidelines.

St.George Respiratory Questionnaire

时间窗: 12 weeks

Quality of life was measured using the Turkish version of St.George Respiratory Questionnaire (SGRQ). It is a specific quality of life questionnaire for respiratory diseases. SGRQ consists of three subscale and 50 items; symptoms (8 items), activities (16 items), effects of the disease (26 items). Each subscale is scored ranging from 0 to 100 points. High scores indicate that worsened the quality of life.

研究点 (1)

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