Abstract
BackgroundChronic 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.MethodsThis 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.DiscussionThis 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 registrationAustralian and New Zealand Clinical Trials Registry (ANZCTR): 12620001085965 (20/10/2020)
Highlights
Chronic obstructive pulmonary disease (COPD) is a disorder linked with a multitude of extra pulmo‐ nary manifestations, including low bone mineral density (BMD)
The deterioration of bone health in people with COPD is of concern given that it is often undiagnosed until bone fractures occur
Recent studies have mainly focused on investigating the prevalence and risk factors for low BMD in people with COPD rather than developing strategies to ameliorate this problematic extrapulmonary manifestation of COPD
Summary
Chronic obstructive pulmonary disease (COPD) is a disorder linked with a multitude of extra pulmo‐ nary manifestations ( known as treatable traits), including low bone mineral density (BMD). Chronic obstructive pulmonary disease (COPD) of moderate severity affects 1 in 10 adults over the age of 40 years and is projected to be the third leading cause of death globally by 2030 [1]. This disease is characterised by airflow limitation that is not fully reversible and results in persistent respiratory symptoms such as dyspnea [2]. People with COPD die with their disease, not from their disease and comorbidities, and extrapulmonary manifestations are known to impact prognosis [3]. Comorbidities and extrapulmonary manifestations in people with COPD have been badged as “treatable traits” [5]
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