Status:
UNKNOWN
Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Associazione Riabilitatori Insufficienza Respiratoria
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
This study will investigate if adding a domiciliary respiratory physiotherapy treatment to standard care in patients with chronic obstructive pulmonary disease (COPD) can improve physical function (wa...
Eligibility Criteria
Inclusion
- Severe COPD (FEV1/FVC \< 70% and FEV1 \< 50% pred.) associated to hypoxaemic chronic respiratory insufficiency (PaO2 \< 60mmHg) or
- Very severe COPD (FEV1/FVC \< 70% and FEV1 \< 30% pred.)
- With the following characteristics:
- no signs of lung restriction (TLC≥80%)
- clinically stable for at least the last four weeks
- MRC ≥ 2
- no participation to PR programmes in the last year
- FEV1= Forced expiratory volume in the 1st second FVC= Forced vital capacity TLC= Total Lung Capacity PaO2= Partial pressure of arterial oxygen
Exclusion
- \- Muscular-skeletal impairment that could limit the patient's participation to the exercise programme;
- Cognitive impairment that could limit the patient's participation to the activities of education and exercise, as assessed by the Mini Mental State (MMS) test \<26;
- Malignancies
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT01198288
Start Date
September 1 2010
End Date
September 1 2012
Last Update
January 31 2012
Active Locations (1)
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1
Unità di pneunologia, Ospedale di Busto Arsizio
Busto Arsizio, Varese, Italy