Randomised Controlled Trial on the Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe COPD

Associazione Riabilitatori Insufficienza Respiratoria1 site in 1 country182 target enrollmentSeptember 2010

ConditionsChronic Obstructive Pulmonary Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Associazione Riabilitatori Insufficienza Respiratoria
Enrollment: 182
Locations: 1
Primary Endpoint: meters as per walking test performance
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 (walking test) and quality of life.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

September 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Associazione Riabilitatori Insufficienza Respiratoria

Responsible Party

Principal Investigator

Marta Lazzeri

Associazione Riabilitatori Insufficienza Respiratoria

Eligibility Criteria

Inclusion Criteria

•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
•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 Criteria

•- 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