A mixed-methods feasibility study of a comorbidity-adapted exercise program for low back pain in older adults (COMEBACK): a protocol

Background: The prevalence of low back pain increases with age and has a profound impact on physical and psychosocial health. With increasing age comes increasing comorbidity, and this also has pronounced health consequences. Whilst exercise is beneficial for a range of health conditions, trials of exercise for low back pain management often exclude older adults. It is currently unknown whether an exercise program for older adults with low back pain, tailored for the presence of comorbidities, is acceptable for participants and primary healthcare providers (PHCPs). Therefore, this mixed-methods study will assess the feasibility of an 8-week comorbidity-adapted exercise program for older people with low back pain and comorbid conditions. 

Methods: The 3-phased feasibility study will be performed in a primary healthcare setting. PHCPs will be trained to deliver a comorbidity-adapted exercise program for older people with low back pain and comorbidities. Healthcare-seeking adults > 65 will be screened for eligibility over telephone, with a recruitment target of 24 participants. Eligible participants will attend an initial appointment (diagnostic phase). During this initial appointment, a research assistant will collect patient demographics, self-reported outcome measurement data, and perform a physical and functional examination to determine contraindications and restrictions to an exercise program. During the development phase, PHCPs will adapt the exercise program to the individual and provide patient education. During the intervention phase, there will be two supervised exercise sessions per week, over 8 weeks (total of 16 exercise sessions). Each exercise session will be approximately 60 min in duration. A qualitative evaluation after the last exercise program session will explore the feasibility of the exercise program for participants and PHCPs. Progression criteria will determine the suitability for a fully powered randomised controlled trial. 

Discussion: This mixed-methods feasibility study will assess an exercise program for older adults with low back pain and comorbidities. Once assessed for feasibility, the exercise program may be tested for effectiveness in a larger, fully powered randomised controlled trial. This information will add to the sparse evidence base on appropriate options for managing back pain in older adults. 

Trial registration: Australian and New Zealand Clinical Trials Registry registration number: ACTRN12621000379819p (06/04/2021; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621000379819p). 

Trial sponsor: Macquarie University, Department of Chiropractic, Faculty of Medicine, Health and Human Sciences, Macquarie University, NSW 2109, Australia.