Feasibility, tolerance and effects of adding impact loading exercise to pulmonary rehabilitation in people with chronic obstructive pulmonary disease: study protocol for a pilot randomised controlled trial

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a disorder linked with a multitude of extra pulmonary manifestations (also known as treatable traits), including low bone mineral density (BMD). To date, no specific guidelines exist for the management of BMD in this population. Impact loading exercise has been identified as an intervention that improves or maintains BMD in other populations. However, the feasibility of and tolerance to impact loading exercise has not been tested in people with COPD. The aim of the proposed study will be to investigate the feasibility and tolerance of adding impact loading exercise to a standard pulmonary rehabilitation programme (PRP) in people with COPD and report its effects on bone health, balance and falls risk. METHODS: This is a protocol for a pilot feasibility and tolerance randomised controlled trial (RCT). Fifty-eight people with COPD will be randomly allocated, on a 1:1 ratio, to either the experimental or control group. Initially, participants in both groups will complete a standard 8-week (twice-weekly) PRP followed by a 32-week period of maintenance exercises. Over the initial 8-week period, participants allocated to the experimental group will also undertake targeted lower limb resistance exercises and commence a programme of impact loading exercises (e.g. bounding and drop jumps). On completion of the initial 8-week PRP, in addition to the standard maintenance exercises, participants in the experimental group will continue with home-based impact loading exercises, four times a week, for the extra 32 weeks. The primary outcome of this study is feasibility of and tolerance to impact loading exercises. Feasibility will be measured using data collected pertaining to recruitment, withdrawal and completion. Adherence to the exercises will be collected using exercise logs. Tolerance to the exercises will be determined using outcomes to assess pain, recording any adverse effects such as a fall and feedback from the participants in semi-structured interviews on completing of the trial. The effects of the 40-week experimental intervention on bone health, balance and falls risk will be reported. DISCUSSION: This pilot RCT will test the feasibility and tolerance of an intervention that has never been trialed in people with COPD. It will also provide initial information regarding the size of the effect this intervention has on outcomes such as BMD, balance and falls risk. These data will be critical when designing a definitive RCT to advance this area of research. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ANZCTR): 12620001085965 (20/10/2020)