INSIGHTS FROM A RANDOMIZED CONTROLLED TRIAL OF PULMONARY REHABILITATION WITH BALANCE TRAINING FOR FALL REDUCTION IN COPD

A. Newman¹, M. Beauchamp^1,2, C. Ellerton², R. Goldstein^3,4,5,6, J. Alison^7,8, G. Dechman^9,10, K. Haines¹¹, S. Harrison¹², A. Holland^13,14,15, A. Lee^15,16, A. Marques¹⁷, L. Spencer^7,18, M. Stickland^19,20, E. Skinner^11,16, D. Brooks^2,1,4,5,6

¹McMaster University, School of Rehabilitation Science, Hamilton, Canada, ²West Park Healthcare Centre, Department of Respiratory Medicine, Toronto, Canada, ³West Park Healthcare Centre, Respiratory Medicine, Toronto, Canada, ⁴University of Toronto, Department of Physical Therapy, Toronto, Canada, ⁵University of Toronto, Rehabilitation Sciences Institute, Toronto, Canada, ⁶University of Toronto, Department of Medicine, Toronto, Canada, ⁷University of Sydney, School of Health Sciences, Sydney, Australia, ⁸Sydney Local Health District, Allied Health, Sydney, Australia, ⁹Dalhousie University and Nova Scotia Health Authority, Department of Medicine, Halifax, Canada, ¹⁰Dalhousie University, School of Physiotherapy, Halifax, Canada, ¹¹University of Melbourne, Department of Critical Care, Melbourne, Australia, ¹²Teesside University, School of Health and Life Sciences, Middlesbrough, United Kingdom, ¹³Alfred Health, Department of Physiotherapy, Melbourne, Australia, ¹⁴Monash University, Respiratory Research, Melbourne, Australia, ¹⁵Institute for Breathing and Sleep, Melbourne, Australia, ¹⁶Monash University, Department of Physiotherapy, Melbourne, Australia, ¹⁷University of Aveiro, Lab3R-Respiratory Research and Rehabilitation Laboratory, Aveiro, Portugal, ¹⁸Royal Prince Alfred Hospital, Department of Physiotherapy, Camperdown, Australia, ¹⁹University of Alberta, Division of Pulmonary Medicine, Edmonton, Canada, ²⁰Covenant Health, G.F. MacDonald Centre for Lung Health, Edmonton, Canada

Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. People with COPD are at an increased risk of falls due to secondary impairments including decreased muscle strength, reduced exercise capacity, and deficits in balance control. Falls are also associated with increased morbidity and mortality. Pulmonary rehabilitation (PR) is fundamental for the management of COPD and is accepted as standard care. Effects of adding a falls prevention component to PR is underexplored and this component is not currently included in international PR guidelines.
To date, many randomized controlled trials (RCT) in PR have had relatively small sample sizes. Conducting multi-centered RCTs can increase the likelihood of obtaining a sufficient sample size when answering important clinical questions. Therefore, an international, multi-centred RCT was conducted to determine if adding balance training to PR would reduce falls risk in people with COPD.
While RCTs are considered one of the highest levels of evidence for guiding clinical practice, they often involve significant human and financial resources to design, conduct, and complete successfully. Many RCTs, even if multi-centred, fail to meet recruitment targets within original study timelines due to a lack of standardized trial management strategies. Standardized management phases and guidelines have been suggested to improve RCT design, implementation, and subsequent success at answering important clinical questions.

Purpose: The purpose of this study was to report on the RCT design, implementation, and execution. The secondary purpose was to highlight lessons learned while conducting an international multi-centered rehabilitation RCT.

Methods: This was a retrospective review of the planning, preparation, timelines, and personnel training involved in the execution of this study using four of the five project management phases described by Farrell et al in 2010:
(1) Initiation,
(2) Planning,
(3) Execution, and
(4) Monitoring and Controlling.
We report descriptive statistics as percentages and counts and summarize the lessons learned.

Results: Nine outpatient PR programs (Canada, United Kingdom, Australia, and Portugal) participated in the trial. Forty-five personnel worked on the trial - central research coordinators (provided training), local study staff, balance trainers, and outcome assessors. Enrolment began in January 2017 and was suspended in March 2020 due to the COVID-19 pandemic. Two sites withdrew due to staffing issues. Approximately 1275 patients were screened; 458 (36%) were eligible; 258 (56%) consented and 150 (61%) completed the full protocol. Insights gained through our experience included:
(1) Initiation: Implications of in-person versus remote training;
(2) Planning: Flexibility with budgetary planning;
(3) Execution: Staffing challenges;
(4) Monitoring and Controlling: Impact of study commitment for patients with complex chronic health conditions, and strategies to maximize patient and personnel engagement.

Conclusions: Conducting a large, international, multi-centered RCT of PR in people with COPD requires rigorous planning, preparation, and monitoring along with significant personnel resources to be successful.

Implications: The results summarize the key management phases of an international multi-centred RCT that can be used to guide future rehabilitation research. The lessons learned can inform future researchers on key strategies that may increase the likelihood of trial management success.

Funding acknowledgements: Funding for this study was provided by the Canadian Institute for Health Research (CIHR) and the Canadian Respiratory Research Network.

Keywords:
Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Rehabilitation
Balance Training

Topics:
Cardiorespiratory
Disability & rehabilitation
Community based rehabilitation

Did this work require ethics approval? Yes

Institution: West Park Healthcare Centre/Toronto Central Community Care Access Centre

Committee: University of Toronto

Ethics number: 33891