Status:
COMPLETED
Non Invasive Mechanical Ventilation in Chronic Respiratory Insufficiency Patients During Rehabilitation
Lead Sponsor:
Fondazione Salvatore Maugeri
Collaborating Sponsors:
Azienda Ospedaliero, Universitaria Pisana
Ataturk Training and Research Hospital
Conditions:
Chronic Respiratory Insufficiency
Eligibility:
All Genders
40-79 years
Phase:
NA
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 patien...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01458314
Start Date
March 1 2011
End Date
October 1 2015
Last Update
November 13 2015
Active Locations (1)
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1
Fondazione Salvatore Maugeri
Lumezzane, Brescia, Italy, 25065