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临床试验/NCT03064711
NCT03064711已完成不适用

Comparison of Activity and Fatigue of the Respiratory Muscles and Pulmonary Characteristics Between Post-Polio Patients and Healthy Controls: A Pilot Study

Hadassah Medical Organization2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年1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
24
试验地点
2
主要终点
Median frequency of electromyography

研究概览

简要总结

Background: Early diagnosis of respiratory impairment in Post-Polio (PPS) patients may delay respiratory decline and future need of invasive respiratory aids.

Objectives: To compare pulmonary function measures, maximal respiratory pressure and activity levels and fatigue of respiratory muscles between patients with PPS and healthy controls.

Design: Cross-sectional study. Setting: Hadassah physical medicine and rehabilitation department, Jerusalem. Patients: Patients with PPS (N=12; 6 males; age 62.1±11.6 years) able to walk for 6 minutes without human assistance; age-matched healthy subjects (N=12; 4 males; age 62.2±6.5 years).

Intervention: None. Measurements: A body plethysmograph was used to quantify forced expiratory volume in the first second of a forced expiratory maneuver, vital capacity, slow vital capacity, Residual Volume (RV), Total Lung Capacity (TLC), and Thoracic Gas Volume (TGV). Also, RV to TLC ratio is calculated. A manometer was used to measure Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP). A spirometer was used to measure Maximal Voluntary Ventilation (MVV). Surface electromyography (sEMG) recorded diaphragmatic muscle activity during rest and while performing MVV.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Diagnosed with post-polio syndrome
  • Able to walk for 6 minutes, with or without walking aids and orthotics but without human assistance

排除标准

  • Any neurological or orthopedic condition, unrelated to post-polio syndrome

结局指标

主要结局

Median frequency of electromyography

时间窗: Two hours

measure related to fatigue measured during maximal voluntary ventilation

次要结局

  • Pulmonary function(Two hours)
  • maximal inspiratory/expiratory pressures(Two hours)

研究者

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

Isabella Shvartz

MD

Hadassah Medical Organization

研究点 (2)

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