Bronchiectasis - Exercise as Therapy (BREATH): Rationale and Study Protocol for a Multi-center Randomized Controlled Trial

Abstract Background: Globally, bronchiectasis (BE) unrelated to cystic fibrosis (CF) is recognized as a major cause of respiratory morbidity, mortality and health-care utilization. Children with BE regularly experience exacerbations of their condition resulting in frequent hospitalizations and decreased health related quality of life (HRQoL). Guidelines for the treatment and management of BE call for regular exercise as it may reduce the incidence of acute exacerbations. To date, the short and long-term health benefits resulting from therapeutic exercise have not been investigated in children with BE. We aim to determine if a therapeutic exercise program is effective in reducing the proportion of children with BE who experience any exacerbation in a 12-month period. The secondary aims are to determine the cost-effectiveness of the intervention, and assess the program’s impact on aerobic fitness, fundamental movement skill (FMS) proficiency, habitual physical activity, HRQoL, and lung function.Methods: This multi-center, observer-blinded, parallel group (1:1 allocation), randomized controlled trial (RCT) will be conducted at three sites. One hundred and seventy-four children aged six to under 13 years with BE will be randomized to a developmentally appropriate, play-based therapeutic exercise program (eight, 60-minute weekly sessions, supplemented by a home-based program) or usual care. Randomization will be stratified by site. Outcome measures (aerobic fitness, fundamental movement skill proficiency, habitual physical activity, HRQoL, and lung function) will be assessed at baseline, 9 weeks, 6 and 12-months. Monthly, parental contact and medical review will document acute respiratory exacerbations and parameters for cost-effectiveness outcomes. Discussion: Results from this study will test the effects of the therapeutic exercise program to prevent acute exacerbations and improve FMS proficiency, fitness, and HRQoL in children with BE. The program could be readily translated with low cost equipment and flexible delivery and have the potential for a major paradigm shift in the way in which therapeutic exercise is prescribed and implemented in children with chronic respiratory conditions. This RCT is required because it will provide long overdue Level 1 evidence regarding the efficacy and cost-effectiveness of tailored therapeutic exercise programs for children with BE.Trial registration: Australian and New Zealand Clinical Trials Register (ANZCTR) number ACTRN12619001008112.