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临床试验/NCT01458314
NCT01458314已完成不适用

Evaluation of the Additional Effect of Non Invasive Mechanical Ventilation During a Rehabilitative Program With Cycloergometer in Patients With Chronic Respiratory Insufficiency Using Nocturnal Home Ventilation

Fondazione Salvatore Maugeri2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2011年3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
35
试验地点
2
主要终点
Effort tolerance measured by 6-minutes Walking test

研究概览

简要总结

Patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic respiratory insufficiency (CRI) have severe dyspnoea during exercise at low load. Physiological studies performed in these patients during a unique session of training have shown a positive effect on exercise tolerance if non-invasive mechanical ventilation (NIV) was added during incremental effort test or endurance. Menadue and coworkers (2009) have shown in CRI patients with hypercapnia, secondary to COPD or cifoscoliosis, that combination of NIV during arm effort test improved ability to perform the exercise. Similar result was not reached using NIV during walking. Further studies have underlined a positive effect of the ventilation therapy during exercise within specific programs of pulmonary rehabilitation (Corner 2009). Moreover, the addition of NIV to an exercise training (ET) program in COPD patients may produce greater benefits in exercise tolerance and quality of life than exercise training alone (Garrod 2000).

A great improvement in health-related quality of life, functional status and gas exchange in COPD patients with chronic hypercapnic respiratory failure with nocturnal NIV compared with patients in pulmonary rehabilitation alone has been also shown by Duieverman (2008). However, in the same study Duieverman did not show any significant difference between groups in terms of tolerance to effort test.

Aim of the study is to evaluate if application of daily NIV during physical training may increase the benefits of rehabilitation in CRI patients with nocturnal NIV compared with patients with nocturnal NIV performing training under spontaneous breathing.

详细描述

INTERVENTION

Group 1 (NIV during training + nocturnal NIV): This group of patients will use the usual NIV during night and will perform a rehabilitative program of at least 20 sessions of training at cycloergometer under NIV.

NO INTERVENTION

Group 2 (training in Spontaneous Breathing [SB] + nocturnal NIV): This group of patients will use the usual NIV during night and will be trained in a rehabilitative daily program without NIV. This group will be considered the "control" group.

Sessions: 30 minutes/session, 2 times/day, 4-5 times a week for a total of 20-25 session in 3 weeks.

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
40 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A total of 50 patients aging 40-79 years will be enrolled ( 8 out of 50 will be from FSM in Lumezzane)
  • Patients with chronic respiratory insufficiency (CRI) in treatment with nocturnal NIV from at least six months;
  • Clinical stability (absence of disease re-exacerbations from at least 4 weeks before the study).

排除标准

  • Cardiac diseases: unstable and/or exercise angina, congestive heart failure cardiac, uncontrolled cardiac arrhythmias, sinus tachycardia at rest (HR >120 bpm), hypertension at rest and/or during effort not adequately checked by therapy
  • Orthopaedic and/or neuromuscular illnesses.

结局指标

主要结局

Effort tolerance measured by 6-minutes Walking test

时间窗: After 3 weeks

Changes from baseline in 6-minutes Walking test

次要结局

  • Gas analysis(After 3 weeks)
  • Effort tolerance evaluated by 6-minutes walking test(After 3 weeks)
  • Endurance at cycloergometer test(After 3 weeks)
  • Effort tolerance measured by 6-minutes Walking test(Follow up at 3 months after the end of the protocol)
  • Quality of life MRF 28(After 3 weeks)
  • Maximal Inspiratory Pressure/Maximal Expiratory Pressure(After 3 weeks)

研究者

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

Michele Vitacca

Principal investigator

Fondazione Salvatore Maugeri

研究点 (2)

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