Title: The co-creation of personalised, multifaceted balance training delivered alongside pulmonary rehabilitation to reduce falls risk for people with Chronic Obstructive Pulmonary Disease
Funder: Department of Health and Social Care

Abstract: Background A greater proportion of people with COPD fall than healthy age-matched adults (40-55% v 30%) due to balance impairment, as a consequence of more pronounced deficits in the proprioceptive system and motor response. Balance strategies adopted by healthy older adults are inhibited by symptoms and inactivity. Physiological mechanisms partly explain falls but social deprivation is also important. Pulmonary rehabilitation is standard care to decrease breathless but balance training is required to reduce falls risk. I am the UK principal investigator on an international trial investigating the effect of pulmonary rehabilitation with balance training on 12-month falls rate. Although ongoing, this trial raises fundamental questions regarding: 1. MechanismsThis information will enable balance training to be personalised according to the needs of people with COPD by attending to deficits in neuromuscular function. Discussions with investigators from the international trial indicate that people in Middleborough, an area of high deprivation, fall 8 times more so social/environmental context also needs to be understood. 2. Activate engagementAdherence to pulmonary rehabilitation is poor (42%) and behavior-change needs to be supported. 3. Promote sustainabilityBenefits of pulmonary rehabilitation diminish after 12-weeks without maintenance. Balance training needs to be embedded into peoples' everyday lives. Research questions1. How can balance training be personlised for people with COPD?2. How can active engagement be encouraged?3. How can balance training be embedded into people's everyday lives? Methods Stage 1 (1-21m). Behavioural component: Update a systematic review extracting the active ingredients of interventions (e.g. behaviour-change techniques and treatment fidelity) to improve balance and quantify the individual intervention response heterogeneity. Physiological component: Twenty people with COPD and 20 healthy age-matched adults will complete neuromuscular and balance tests. I will investigate the relationship between tests and between-group differences to identify a variable(s) assessing neuromuscular function. Psychosocial component: Observe 10 patients/carers in their homes and have informal discussions to understand the lived experience of people with COPD. Stage 2 (22-24m). Synthesise findings to co-create personalised, multifaceted balance training for people with COPD and a clinician-training package (beta protocol). Two stakeholder/clinician/patient workshops will refine balance training (alpha protocol). Stage 3 (25-63m). All elements of a definitive trial will be piloted. Forty people with COPD will be randomised to 7-weeks of pulmonary rehabilitation with or without balance training, before a 6-month supported home programme. I will investigate any improvements in balance and if these relate to neuromuscular function. Monthly phone calls will monitor falls and treatment adherence. Support needs to sustain balance training will be identified using an ethnographic approach, consisting of time-series home-based observations and rapid-informal interviews (total n=24 observations) with patient/carer dyads assigned to balance training. A fidelity assessment and economic evaluation will run alongside the pilot-RCT. Anticipated impact and dissemination Eight pulmonary rehabilitation roadshows targeted at socially deprived areas of the UK will deliver training based on the clinician-training package. One show will be recorded for web-based dissemination. Experts in digital design and ideation will support innovative ways to disseminate findings publically. Findings will be published in scientific journals.

Lay abstract: Background COPD affects 1.2million people in the UK. Patients are breathless and often live in the poorest communities. They are four times more likely to fall than healthy adults of the same age because balance is worse. As we age muscles become weaker and slower to react to unsteadiness. Symptoms and inactivity mean this happens quicker in people with COPD. Physical changes are only one reason people fall, social and environmental factors are also important. For example, people caring for grandchildren, because childcare is not affordable, and living in small houses are more likely to fall over toys. Pulmonary rehabilitation is usual treatment for COPD, including 6-8 weeks of exercise and disease education, to reduce breathlessness. Balance training is not included but is needed to reduce falls risk. I am leading the UK part of an international research study testing if pulmonary rehabilitation with balance training reduces falls. Although ongoing, this research raises interesting questions: Can balance training be personalised? Balance training can be improved if it meets the physical needs of people with COPD. Discussions with other international investigators indicate that people recruited in Middlesbrough (an area with poor communities) fall 8 times more than those from other countries. This may be due to social and environmental situations that we need to understand better. Can we encourage attendance? Only 42% of people with COPD complete pulmonary rehabilitation. Can balance training be continued at home? Most benefits of exercise disappear after 12-weeks if discontinued.Aims 1. Personalise pulmonary rehabilitation with balance training for people with COPD, 2. Encourage attendance 3. Fit balance training into patients' everyday lives. Design and methods Stage 1 (1-21m). Behavioural component: Review research to identify what aspects of exercise training improve balance in people with COPD. Physical component: Investigate if poor balance is due to weaker muscles and slower reactions by comparing associations in 20 people with COPD to 20 healthy older adults. Psychosocial component: Observe 10 people with COPD (and carers) in their homes and have discussions to understand their experience of living with COPD. Stage 2 (22-24m). Draw together findings from stage 1 to develop balance training for people with COPD and a training package for clinicians to deliver it. Stakeholders, clinicians, patients and carers will help improve balance training. Stage 3 (25-63m). Forty people with COPD will receive pulmonary rehabilitation with or without balance training consisting of twice weekly sessions at hospital and one at home, followed by a 6-month supported home programme. Monthly phone calls will enquire about falls and home exercise/balance training. Balance and muscle testing will take place before and after pulmonary rehabilitation and 6-months later. I will also observe and interview 8 people with COPD receiving balance training in their homes, sometimes with their carers, at these time-points to uncover what support is needed to continue balance training. I will assess if balance training was delivered as intended and the cost of delivery. This information will inform a future trial. Patient and public involvement Six patients enrolled in pulmonary rehabilitation, seven Breathe Easy support group members and a PPI consumer panel supported the development of the research programme (e.g. to include monthly phone calls). Three meetings a year will be held with 10-20 Breathe Easy members and the research team will include two patients. Dissemination I will deliver 8 pulmonary rehabilitation roadshows, based on the clinician-training package, in the poorest communities to patients, carers and clinicians. One show will be video-recorded for use online. People from creative arts and games industries will help develop exciting ways to disseminate results to the public. Findings will be published in scientific journals.

Research activity codes: 6.7 PHYSICAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: RESPIRATORY