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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Standard Care; Other: domiciliary rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 182
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Marta Lazzeri; Email: presidenza@arirassociazione.org

Study Locations

• Italy
  • Varese
    • Busto Arsizio, Varese, Italy
      • Recruiting
      • Unità di pneunologia, Ospedale di Busto Arsizio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: Standard Care; As describe in the standard care arm
Experimental: 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.	Other: domiciliary rehabilitation; a respiratory rehabilitation programme at the patient home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
meters as per walking test performance	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life		6 months
Quality of life		12 months
Quality of life		8 weeks
Bode index	This index is a combination of walking test result, Body Mass Index and respiratory measurement	8 weeks
dyspnea		8 weeks
relapses		8 weeks
services utilization	visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )	8 weeks
meters as per walking test performance		6 months
Bode index	This index is a combination of walking test result, Body Mass Index and respiratory measurement	6 months
dyspnea		6 months
relapses		6 months
services utilization	visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )	6 months
meters as per walking test performance		12 months
Bode index	This index is a combination of walking test result, Body Mass Index and respiratory measurement	12 months
dyspnea		12 months
relapses		12 months
services utilization	visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )	12 months

Collaborators and Investigators

• Sponsor: Associazione Riabilitatori Insufficienza Respiratoria

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: September 7, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Estimate): January 31, 2012
• Last Update Submitted That Met QC Criteria: January 30, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: COPD; Respiratory Physiotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 01 (Miami VAHS)