Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Phase 3

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01198288
• Lead Sponsor: Associazione Riabilitatori Insufficienza Respiratoria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-30
• Last Update Posted: 2012-01-31
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 182

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
• 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
meters as per walking test performance	8 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life	12 months
services utilization	12 months	visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )
Bode index	12 months	This index is a combination of walking test result, Body Mass Index and respiratory measurement
dyspnea	12 months
relapses	12 months
meters as per walking test performance	12 months

Trial Locations

Locations (1)

Unità di pneunologia, Ospedale di Busto Arsizio; 🇮🇹 Busto Arsizio, Varese, Italy