Rehabilitative intervention of frailty for patients with chronic respiratory disease (REINFORCE study): research protocol for a multicentre, randomised controlled trial.

BACKGROUND

Pulmonary rehabilitation, primarily with exercise training, is well-established for patients with chronic obstructive pulmonary disease (COPD); however, rehabilitative intervention specifically targeting physical frailty in patients with chronic respiratory disease (CRD) remains unexplored. This study evaluates a rehabilitative intervention for frailty in older patients with CRDs (REINFORCE), including various lung diseases.

METHODS

This multicentre, prospective, randomised, controlled trial will enrol 184 patients with CRD. Patients will undergo a 4-week programme focused on addressing declined physical functions, as measured by the Short Physical Performance Battery (SPPB) items such as balance, walking, and/or sit-to-stand chair test. The primary outcome is the change in daily step count as a physical activity measure before and after the programme between the two groups. Secondary outcomes include changes in the SPPB score, peripheral muscle strength (handgrip and quadriceps), 6-minute walk distance (6MWD), and health-related quality of life (HRQL) scores at 4 weeks and 1 year.

DISCUSSION: The REINFORCE study is designed to be one of the first randomised trials targeting frailty in CRD and aims to explore the feasibility and potential benefit of a novel intervention to improve physical activity levels.

TRIAL REGISTRATION: This randomised controlled trial was prospectively registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) under the registration number UMIN000053979 on June 1, 2024.