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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01198288

Enrollment

182

Registered

2010-09-10

Start date

2010-09-30

Completion date

2012-09-30

Last updated

2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Respiratory Physiotherapy

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.

Interventions

OTHERdomiciliary rehabilitation

a respiratory rehabilitation programme at the patient home

OTHERStandard Care

As describe in the standard care arm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
meters as per walking test performance	8 weeks

Secondary

Measure	Time frame	Description
meters as per walking test performance	6 months	—
Quality of life	8 weeks	—
Bode index	8 weeks	This index is a combination of walking test result, Body Mass Index and respiratory measurement
dyspnea	8 weeks	—
relapses	8 weeks	—
services utilization	8 weeks	visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )

Countries

Italy

Contacts

Primary ContactMarta Lazzeri

presidenza@arirassociazione.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026