Effectiveness of a home-based pulmonary rehabilitation maintenance programme: the Rehab2Life study protocol.

Abstract

Pulmonary rehabilitation (PR) is the bedrock of non-pharmacological treatment for people with COPD. Nonetheless, it is well described in the literature that unless the patient changes his behaviour, the benefits of PR programmes will decline in six to twelve months after finishing the programme. Therefore, maintenance programmes can address the problem of PR programmes' effect loss over time.Community care units can provide multidisciplinary care in the current Portuguese primary health care context. These units have an interdisciplinary team that aims to develop competencies in COPD patients to self-manage the disease.This study aims to test the effectiveness of a 12-month home-based PR programme (Rehab2Life) compared to usual care through a single-blind randomised controlled trial with two parallel groups. The Rehab2Life programme includes two distinct phases. The first is an 8-week PR programme delivered to both groups, and the second is a PR maintenance programme delivered to the intervention group after the initial eight weeks. The control group receive the usual care and regular appointments. The primary outcome is functional capacity, and secondary outcomes are dyspnea, Health-Related Quality of Life (HRQoL), number of exacerbations, symptoms burden, anxiety and depression symptoms, and physical activity.We expect to observe that the home-based PR programme brings clinically relevant benefits to the participants at the end of the first eight weeks and that, at 12 months after the maintenance phase of the programme, benefits are less dissipated than in the control group. We expect to identify the characteristics of the patients who benefit the most from home-based programmes.The trial was registered on 7 April 2022 at ClinicalTrials.gov (NCT05315505).