S McKenna1, L Comber1, A Donnelly2, A Fraser3, B Appel Esbensen4, N Kennedy5
1University of Limerick, School of Allied Health, Limerick, Ireland, 2University of Limerick, Department of Physical Education and Sport Sciences, Limerick, Ireland, 3University Hospitals Limerick, Department of Rheumatology, Limerick, Ireland, 4Copenhagen Center for Arthritis Research, Rigshospitalet, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, 5University of Limerick, Office of the Vice President of Research, Limerick, Ireland
Background: Poor sleep quality and reduced sleep duration are prevalent complaints in people with RA. These in turn may further deteriorate functional ability and reduce their levels of exercise. Current rheumatology guidelines recommend exercise as a key component in the management of people with RA however, what is lacking is research looking at its impact on sleep.
Purpose: The purpose of this pilot randomised controlled trial was to obtain reliable estimates regarding recruitment rates; participant retention; protocol adherence and possible adverse events, in addition to producing estimates of the potential effect sizes of the intervention on changes in outcomes of sleep duration; sleep quality and disturbances; pain; depression; anxiety; functional limitation; disease activity and fatigue.
Methods: Participants were recruited in person at weekly rheumatology clinics at a University Hospital and through self-selected social networking. They were randomised to either a walking based exercise intervention consisting of 28 walking sessions, with 1 per week being supervised by a trained chartered physiotherapist, spread over 8 weeks (2-5 times/week), or a control group who received advice on the benefits of exercise for people with RA. Ethical approval was received. Descriptive statistics and t-tests were used to analyse the data with SPSS v22.
Results: One hundred and one (101) people were identified through the rheumatology clinics, with 36 contacting the primary investigator through social networking. Of these, 24 met the eligibility criteria, with 20 being randomised (18% recruitment; 100% female; mean age 57 (SD 7.3 years). Ten exercise participants (100%) and 8 controls (80%) completed final assessments, with both groups being equivalent for all variables at baseline. Exercise participants completed 87.5% of supervised sessions and 93% of unsupervised sessions. No serious adverse events were related to the intervention and through semi-structured interviews the intervention was highly acceptable to exercise participants. Pittsburgh Sleep Quality Index (PSQI) global score showed a significant mean improvement between the exercise group -6.6 (SD 3.3) compared to control -0.25 (SD 1.1) (p=0.012); PSQI subcomponent sleep duration showed a significant improvement in mean hours between the exercise group 1.65 (SD 0.39) hours and control 0.56 (SD 0.46) hours (p=0.021); PSQI subcomponent sleep quality indicated those in the exercise group improved their sleep quality from fairly bad/poor to fairly good/very good, while those in control reported no change at fairly bad/poor. Global rating of change indicated exercise participants reporting their sleep was minimally/much improved, while control participants reported no change/minimally worse, post intervention.
Conclusion(s): The walking based exercise intervention designed to improve sleep quality and sleep duration was found to be feasible, safe and highly acceptable to study participants, with those participants in the exercise group reporting improvements in sleep duration and sleep quality compared to the control group. Adverse events were predominantly mild.
Implications: This pilot provides a framework for larger intervention studies and based on these findings a fully powered trial of walking as an exercise based intervention is recommended, preceded by focus groups to investigate methods to improve recruitment of males.
Funding, acknowledgements: Sean McKenna reports a competitive postgraduate scholarship awarded by the Irish Research Council (IRC) (GOIPG/2016/58).
Keywords: Inflammatory arthritis, Sleep, Exercise
Topic: Rheumatology
Did this work require ethics approval? Yes
Institution: University Hospital Limerick, Ireland
Committee: Research Ethics Committee
Ethics number: REC ref: 60/17
All authors, affiliations and abstracts have been published as submitted.