Home-based Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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This project aims to assess the short-term effectiveness and responsiveness of a home-based pulmonary rehabilitation (PR) program (reabilitAR) in patients with chronic obstructive pulmonary disease (COPD). It is also an aim to establish the minimal clinically important differences for PR in patients with COPD for a novel incremental step test (exercise capacity outcome measure). Patients will be recruited at hospitals. Sociodemographic, anthropometric, and comorbidities; vital signs and peripheral oxygen saturation; symptoms (dyspnea, fatigue); lung function; functional capacity; exercise capacity; the impact of the disease, balance, and cognitive function will be collected before the reabilitAR program. Additionally, health care utilization will be registered. Then, patients will be entered into the reabilitAR program (12 weeks). The intervention consists in a strategic mixture of home visits and phone calls. The program includes exercise training and the self-management educational program Living Well with COPD. After 12 weeks all outcome measures will be reassessed. It is expected that the home-based approach will express benefits and reflect the concerns to provide appropriate responses to the patient's needs by increasing access to PR.

Detailed Description
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The World Health Organization (WHO) indicates that hundreds of millions of people worldwide are affected by chronic respiratory diseases (CRD), including chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation (PR) is an essential component in the management of CRD with the aim to improve patients' exercise and functional capacity and psychological condition with long-term adherence to health-enhancing behaviors, including exercise training and self-management skills. However, despite the well-known evidence, this service is mostly underutilized due to poor accessibility, with only 1% of worldwide availability of PR services for COPD patients. Thus, is important to undertake actions that improve access to and delivery of PR services for suitable patients. One of the strategies in the international guidelines is the creation of new models of programs, where a home-based approach is indicated. The aim of this project is to assess the short-term effectiveness and responsiveness of a home-based pulmonary rehabilitation program (reabilitAR) in patients with COPD. It is also an aim to establish the minimal clinically important differences for PR in patients with COPD for a novel incremental step test (exercise capacity outcome measure). The plan is to recruit the maximum of patients with COPD via clinicians at hospitals. This study will enroll adult patients with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. Patients will be referred by pulmonologists, from medical consultation in hospitals and clinics in Portugal. With the referral, it is expected that the medical doctor explains the goal and benefits of PR. Eligible patients will be contacted by the reabilitAR team, for additional questions and to begin the integration process. Sociodemographic, anthropometric, and comorbidities; vital signs and peripheral oxygen saturation; symptoms (dyspnea, fatigue); lung function; functional capacity; exercise capacity; the impact of the disease, balance, and cognitive function will be collected before the reabilitAR program. Additionally, health care utilization will be registered. The program consists in home visits for the exercise training and the self-management sessions, and motivational phone-calls including the follow-up of the clinical condition, the progression of exercise training, including a total of 14 home visits, with more visits in the first two weeks of the program (4 visits). From the third week, one visit will be replaced by a phone call, for a total of 10 phone calls. After 12 weeks all outcome measures will be reassessed.

Official Title
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Home-based Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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COPD

Intervention / Treatment
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* Other: Home-based pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of COPD based on the GOLD criteria - postbronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <70%; Electrocardiogram (ECG) record at rest; Written informed consent form; Exclusion Criteria: Presence of any clinical condition that does not allow the participants to a home-based PR program, such as, significant cardiovascular (e.g. symptomatic ischaemic cardiac disease), neurological (e.g. neuromuscular dystrophy disease), or presence of musculoskeletal disease; Signs of cognitive impairment (e.g. dementia).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Home-based pulmonary rehabilitation<br>Patients will be treated for 12 weeks. The intervention consists in a strategic mixture of home visits and phone calls. The program includes exercise training and the self-management educational program Living Well with COPD. | Other: Home-based pulmonary rehabilitation<br>* The reabilitAR program includes the self-management educational program Living Well with COPD. The exercise training will include endurance, resistance/strength, flexibility and balance training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline number of steps (incremental step test) at 12 weeks | The incremental step test will be used to assess exercise capacity | At baseline and up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline number of repetitions (1-minute sit-to-stand test) at 12 weeks | The 1-minute sit-to-stand test will be used to assess functional capacity | At baseline and up to 12 weeks | 
| Change from baseline score of CAT at 12 weeks | COPD Assessment Test (CAT) will be used to assess impact of the disease. The individual score of each item is added to provide a total score that can range from 0 to 40. Total scores inferior to 10 are considered as reduced impact, from 10-20 as medium impact, from 21- 30 as high impact and above 30 as very high impact. | At baseline and up to 12 weeks | 
| Change from baseline score of dyspnea at 12 weeks | Modified Borg scale will be used to assess patients' level of dyspnea. 0-10 scale is used to measure perceived dyspnea where 0 is not at all and 10 is maximal | At baseline and up to 12 weeks | 
| Change from baseline score of fatigue at 12 weeks | Modified Borg Scale will be used to assess patients' level of fatigue. 0-10 scale is used to measure perceived fatigue where 0 is not at all and 10 is maximal | At baseline and up to 12 weeks | 
| Change from baseline score of London Chest Activities of Daily Living at 12 weeks | London Chest Activities of Daily Living will be used to assess patients' level of dyspnea performing activities of daily living. The individual score of each item is added to provide a total score that can range from 0 to 75 where maximal score represents a higher level of dyspnea. | At baseline and up to 12 weeks | 
| Change from baseline score of Hospital Anxiety and Depression Scale at 12 weeks | Hospital Anxiety and Depression Scale will be used to assess patients' emotional status. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression symptoms. | At baseline and up to 12 weeks | 
| Number of exacerbations | Patients' number of hospitalizations in the previous year and during the rehabilitation will be assessed by asking the patient to self-report it. | Up to 12 weeks | 
| Change from baseline score of mMRC at 12 weeks | Modified British Medical Research Council (mMRC) questionnaire will be used to assess patients' level of dyspnea.This questionnaire comprises five grades in a scale from 0 to 4, with higher grades indicating greater perceived respiratory limitation. | At baseline and up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home-based pulmonary rehabilitation, exercise training, self-management