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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01198288
• Other study ID #: 01
• Status: Recruiting
• Phase: Phase 3
• First received: September 7, 2010
• Last updated: January 30, 2012
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: January 2012
• Source: Associazione Riabilitatori Insufficienza Respiratoria
• Contact: Marta Lazzeri
• Email: presidenza[@]arirassociazione.org
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• domiciliary rehabilitation
a respiratory rehabilitation programme at the patient home
• Standard Care
As describe in the standard care arm

Locations

Country	Name	City	State
Italy	Unità di pneunologia, Ospedale di Busto Arsizio	Busto Arsizio	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Associazione Riabilitatori Insufficienza Respiratoria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	meters as per walking test performance		8 weeks	No
Secondary	Quality of life		8 weeks	No
Secondary	Bode index	This index is a combination of walking test result, Body Mass Index and respiratory measurement	8 weeks	No
Secondary	dyspnea		8 weeks	No
Secondary	relapses		8 weeks	No
Secondary	services utilization	visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )	8 weeks	No
Secondary	meters as per walking test performance		6 months	No
Secondary	Quality of life		6 months	No
Secondary	Bode index	This index is a combination of walking test result, Body Mass Index and respiratory measurement	6 months	No
Secondary	dyspnea		6 months	No
Secondary	relapses		6 months	No
Secondary	services utilization	visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )	6 months	No
Secondary	meters as per walking test performance		12 months	No
Secondary	Quality of life		12 months	No
Secondary	Bode index	This index is a combination of walking test result, Body Mass Index and respiratory measurement	12 months	No
Secondary	dyspnea		12 months	No
Secondary	relapses		12 months	No
Secondary	services utilization	visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )	12 months	No