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
• Interventions: Other: Standard Care; Other: domiciliary rehabilitation

• 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

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	Drugs for COPD (as prescribed), oxygen therapy if needed\*, check-up by the general practitioner and/or respirologist as usual. Educational leaflet regarding optimization of oxygen therapy and drugs; Benefits of physical activity and proposal of a programme of exercise training; Energy conservation techniques; Nutritional counselling; Activity of daily Living (ADL) diary; Prevention and management of acute exacerbation Monthly phone call with the aim of verifying: * the patients' clinical conditions; * the patient's adherence to the pharmacological treatments prescribed * the patient's compliance in filling out the clinical diary and the ADL diary
domiciliary rehabilitation	domiciliary rehabilitation	Same as the standard care group plus 10 (ten) home-based visits supervised by a specifically trained respiratory therapist (education+exercise training) Autonomous home-based programme: The patients will be given instructions and training in order to continue the exercise training programme on the days the respiratory therapist is not visiting them. Counselling addressed at the outdoor activities.

Primary Outcome Measures

Name	Time	Method
meters as per walking test performance	8 weeks

Secondary Outcome Measures

Name	Time	Method
services utilization	12 months	visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )
Quality of life	12 months
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