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

NCT01198288 | Unknown Phase 3

• 1 other identifier: 01
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Respiratory Physiotherapy

Outcome Measures

Primary Outcomes (1)

• meters as per walking test performance

  8 weeks

Secondary Outcomes (17)

• Quality of life

  8 weeks

• Bode index

  8 weeks

• dyspnea

  8 weeks

• relapses

  8 weeks

• services utilization

  8 weeks

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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

domiciliary rehabilitation

EXPERIMENTAL

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

Interventions

domiciliary rehabilitation OTHER

a respiratory rehabilitation programme at the patient home

domiciliary rehabilitation

Standard Care OTHER

As describe in the standard care arm

Standard Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Associazione Riabilitatori Insufficienza Respiratoria: lead

Study Sites (1)

Unità di pneunologia, Ospedale di Busto Arsizio

Busto Arsizio, Varese, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Marta Lazzeri

CONTACT

presidenza@arirassociazione.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 10, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

IT (1)