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More info
You can access this
clinical trial
if you have
Chronic Respiratory Insufficiency
and you are
between 40 and 79
years old
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Other: Daily NIV during rehabilitation
  • Other: Rehabilitation without NIV

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01458314. The sponsor of the trial is Fondazione Salvatore Maugeri and it is looking for 35 volunteers for the current phase.
Official trial title:
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