Clinical trial NCT04722224: Home-based Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
Official title: Home-based Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Keywords: home-based pulmonary rehabilitation
exercise training
self-management
Lead sponsor: Polytechnic Institute of Porto
Sponsor class: OTHER
Collaborators: name: Nippon Gases Portugal
First posted: 2021-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline number of steps (incremental step test) at 12 weeks
timeFrame: At baseline and up to 12 weeks
Secondary outcomes:
measure: Change from baseline number of repetitions (1-minute sit-to-stand test) at 12 weeks
timeFrame: At baseline and up to 12 weeks
measure: Change from baseline score of CAT at 12 weeks
timeFrame: At baseline and up to 12 weeks
measure: Change from baseline score of dyspnea at 12 weeks
timeFrame: At baseline and up to 12 weeks
measure: Change from baseline score of fatigue at 12 weeks
timeFrame: At baseline and up to 12 weeks
measure: Change from baseline score of London Chest Activities of Daily Living at 12 weeks
timeFrame: At baseline and up to 12 weeks
measure: Change from baseline score of Hospital Anxiety and Depression Scale at 12 weeks
timeFrame: At baseline and up to 12 weeks
measure: Number of exacerbations
timeFrame: Up to 12 weeks
measure: Change from baseline score of mMRC at 12 weeks
timeFrame: At baseline and up to 12 weeks
Other outcomes:
measure: Short Form Berg Balance Scale 3 Point
timeFrame: At baseline
measure: Mini-Mental State Examination (MMSE)
timeFrame: At baseline
Locations:
city: Porto
country: Portugal
facility: Rui Vilarinho
Study officials:
affiliation: School of Health, Polytechnic Institute of Porto
name: Rui A Vilarinho, Master
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Singh D, Agusti A, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Criner GJ, Frith P, Halpin DMG, Han M, Lopez Varela MV, Martinez F, Montes de Oca M, Papi A, Pavord ID, Roche N, Sin DD, Stockley R, Vestbo J, Wedzicha JA, Vogelmeier C. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease: the GOLD science committee report 2019. Eur Respir J. 2019 May 18;53(5):1900164. doi: 10.1183/13993003.00164-2019. Print 2019 May.