Non Invasive Mechanical Ventilation in Chronic Respiratory Insufficiency Patients During Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01458314
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : November 13, 2015
Azienda Ospedaliero, Universitaria Pisana
Ataturk Training and Research Hospital
Information provided by (Responsible Party):
Michele Vitacca, Fondazione Salvatore Maugeri

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Chronic Respiratory Insufficiency Other: Daily NIV during rehabilitation Other: Rehabilitation without NIV Not Applicable

Detailed Description:


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.


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.

Intensity: each patient will start at 50% of each individual's maximum work capacity (cycloergometer) increasing up to the maximum tolerated, according to Maltais's protocol.


Training: Facial mask with usual setting (Inspiratory Positive Airway Pressure [IPAP] 10-15; Expiratory Positive Airway Pressure [EPAP] 4-6 cmH20) with a possible adjustment in agreement with the comfort.

The adjustment of ventilation during training will be only within the first 3 sessions according to the following protocol:

COPD patients: increase up to 3 cmH2Os of EPAP and decrease up to 3 cmH2Os of IPAP.

Restricted patients: increase up to 3 cmH2Os of IPAP.

Nocturnal ventilation: mask and usual setting

The primary outcome of the study is evaluation of effort tolerance measured by 6 minutes Walking Test (6-min Walking Test). The hypothesis is to verify a percentage of variation between the two groups equal to 10% after the rehabilitative program. To get a study power of 80% and an alpha error <5% 25 patients for group had to be enrolled.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Rehabilitation without NIV
A usual rehabilitative training will be performed in patients using nocturnal NIV, without adoption of daily NIV
Other: Rehabilitation without NIV
Training in patients without NIV adoption
Other Names:
  • Group 2
  • No intervention

Experimental: Daily NIV during rehabilitation
Daily NIV will be adopted during the rehabilitation program in patients already using nocturnal NIV
Other: Daily NIV during rehabilitation
Addition of non invasive mechanical ventilation (NIV) during daily rehabilitation in patients using nocturnal NIV
Other Names:
  • Group 1
  • Intervention

Primary Outcome Measures :
  1. Effort tolerance measured by 6-minutes Walking test [ Time Frame: After 3 weeks ]
    Changes from baseline in 6-minutes Walking test

Secondary Outcome Measures :
  1. Maximal Inspiratory Pressure/Maximal Expiratory Pressure [ Time Frame: After 3 weeks ]
  2. Quality of life MRF 28 [ Time Frame: After 3 weeks ]
  3. Gas analysis [ Time Frame: After 3 weeks ]
  4. Effort tolerance evaluated by 6-minutes walking test [ Time Frame: After 3 weeks ]
    Changes in 6-minutes walking test evaluated at the end of the program

  5. Endurance at cycloergometer test [ Time Frame: After 3 weeks ]
  6. Effort tolerance measured by 6-minutes Walking test [ Time Frame: Follow up at 3 months after the end of the protocol ]
    Changes in 6-minutes Walking test evaluated 3 months after the end of the protocol

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01458314

Fondazione Salvatore Maugeri
Lumezzane, Brescia, Italy, 25065
Sponsors and Collaborators
Fondazione Salvatore Maugeri
Azienda Ospedaliero, Universitaria Pisana
Ataturk Training and Research Hospital
Principal Investigator: Michele Vitacca, MD Fondazione Salvatore Maugeri

Responsible Party: Michele Vitacca, Principal investigator, Fondazione Salvatore Maugeri Identifier: NCT01458314     History of Changes
Other Study ID Numbers: CTS/10/01
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Keywords provided by Michele Vitacca, Fondazione Salvatore Maugeri:
Physical exercise

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases