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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: domiciliary rehabilitation
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br>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<br>* As describe in the standard care arm<br>|
| Experimental: domiciliary rehabilitation<br>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<br>* a respiratory rehabilitation programme at the patient home<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Quality of life |  | 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 | 
| Quality of life |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Respiratory Physiotherapy