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

Associazione Riabilitatori Insufficienza Respiratoria

Status and phase: Unknown; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: domiciliary rehabilitation; Other: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01198288

01

Details and patient eligibility

About

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.

Enrollment: 182 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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182 participants in 2 patient groups

Standard Care

Active Comparator group

Description:

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

Treatment:

Other: Standard Care

domiciliary rehabilitation

Experimental group

Description:

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.

Treatment:

Other: domiciliary rehabilitation