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
Sponsor study identifier
interventional
35
1 country
1
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
October 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
October 12, 2011
Actual (reported)October 24, 2011
Actual (reported)June 2015
Actual (reported)October 2015
Actual (reported)Effort tolerance measured by 6-minutes Walking test
Changes from baseline in 6-minutes Walking test
After 3 weeks
Maximal Inspiratory Pressure/Maximal Expiratory Pressure
After 3 weeks
Quality of life MRF 28
After 3 weeks
Gas analysis
After 3 weeks
Effort tolerance evaluated by 6-minutes walking test
After 3 weeks
Endurance at cycloergometer test
After 3 weeks
A usual rehabilitative training will be performed in patients using nocturnal NIV, without adoption of daily NIV
Daily NIV will be adopted during the rehabilitation program in patients already using nocturnal NIV
Addition of non invasive mechanical ventilation (NIV) during daily rehabilitation in patients using nocturnal NIV
Training in patients without NIV adoption
Fondazione Salvatore Maugeri
Lumezzane, Brescia, 25065, Italy
Vitacca M, Kaymaz D, Lanini B, Vagheggini G, Ergun P, Gigliotti F, Ambrosino N, Paneroni M. Non-invasive ventilation during cycle exercise training in patients with chronic respiratory failure on long-term ventilatory support: A randomized controlled trial. Respirology. 2018 Feb;23(2):182-189. doi: 10.1111/resp.13181. Epub 2017 Sep 22.
Michele Vitacca, MD
Fondazione Salvatore Maugeri
35 participants (actual enrollment reported by the registry).
First Submitted
October 12, 2011
First Posted
October 24, 2011
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
June 2015
Actual (reported)Study Completion
October 2015
Actual (reported)Last Updated
November 13, 2015
Record last verified: 2015-11
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