Background:The PIPPRA (Physiotherapist-led Intervention to Promote Physical Activity in Rheumatoid Arthritis) project is a feasibility project examining the impact of a physical activity behaviour change intervention in people who have rheumatoid arthritis (RA). The PIPPRA study recruitment commenced in October 2019, with participant assessment and intervention commencing in November 2019. In the Republic of Ireland people who have RA are categorised as high risk category for Covid-19, due to immunosuppression [1], although this categorisation contrasts with EULAR’s provisional recommendations [2].Objectives:To examine the impact of the Covid-19 pandemic and public health restrictions on a pilot randomised controlled feasibility study in 2020.Methods:Participants (aged 18 years+, diagnosis of RA, independently mobile and low levels of physical activity [3]) were recruited from a rheumatology clinic at an urban hospital. Target recruitment was four participants per month for one year (N=48). Assessments were planned at baseline, eight and twenty-four weeks (N=144). Participants were randomised to intervention group or control group. The intervention group received four 1:1 sixty minute sessions with a physiotherapist (N=96). The intervention was delivered over eight weeks. Intervention and control groups received a physical activity information leaflet.Results:The Covid-19 pandemic and associated public health restrictions forced the study to be formally paused in April 2020 and the study formally resumed in August 2020. N=48 participants were recruited between October 2019 and March 2020 (six months). N=20 participants have commenced in the study, N=16 are awaiting baseline assessment, N=6 withdrew and N=6 were lost to follow-up prior to baseline. Trial protocol planned for the delivery of N=55 assessments and N=36 intervention sessions for participants who had commenced in the study. N=22 assessments and N=26 intervention sessions were delivered between November 2019 and March 2020. N=5 assessments and N=6 intervention sessions were conducted between August and October 2020. No assessment or intervention delivery occurred in November-December 2020 due to participant hesitancy in attending for assessment and/or intervention with increased public health restrictions. The impact of Covid-19 restrictions resulted in N=33 (60%) deviations from assessment protocol and N=10 (27%) deviations from intervention delivery protocol (Figure 1).Figure 1.Deviations from assessment and intervention protocol in the PIPPRA studyConclusion:The Covid-19 pandemic has had a significant impact on the delivery of the PIPPRA study. Feasibility study outcomes, including participant retention rate, and study delivery as per protocol, have been affected due to the Covid-19 pandemic. Participant reluctance to attend face-to-face sessions demonstrates the need to consider alternative methods of delivery, e.g. virtual delivery of interventions, where attending in person is not acceptable to participants [4], in future studies.References:[1]Health Service Executive. (2019). People at higher risk from COVID-19.Accessed 5th Jan 2020 https://www2.hse.ie/conditions/coronavirus/people-at-higher-risk.html.[2]Landewé RB et al (2020). EULAR provisional recommendations for the management of rheumatic and musculoskeletal diseases in the context of SARS-CoV-2. Annals of the Rheumatic Diseases 79:851-858.[3]Godin, G. (2011). The Godin-Shephard leisure-time physical activity questionnaire. The Health & Fitness Journal of Canada, 4(1):18-22.[4]Inan, OT et al. (2020). Digitizing clinical trials. npj Digit. Med. 3:10.Disclosure of Interests:None declared
Accelerometer-based assessment of physical activity within the Fun For Wellness online behavioral intervention: protocol for a feasibility study
