Integração de programa de atividade física e tecnologia móvel para redução da dor e incapacidade em idosos com dor lombar na atenção primária: estudo de viabilidade de ensaio clínico aleatorizado

Abstract

Low back pain (LBP) is more disabling in older people. Although its impact on functioning is large, the management of LBP in the older adults has been little studied. Strategies that integrate exercise, education and mobile technologies can reduce the impact of LBP in the older population. Understanding that interventions like this have not yet been investigated in the Brazilian primary care, a feasibility study is necessary for the future conduct of a study. Thus, the aim was to evaluate the feasibility of a randomized controlled trial investigating the effectiveness of program of physical exercise and pain education, supported by low-cost mobile technology (PAT-Back), compared to best practice advice, on pain, disability, and functional capacity in older adults with chronic LBP in primary care. Protocol and feasibility study of a clinical trial were developed. Primary outcomes were: recruitment rate, adherence and retention rates, difficulty in understanding of the education, safety and difficulty in perform to exercise, perception of messages and adverse events. Secondary outcomes were: pain, LBP-related disability, functional capacity, physical activity, depressive symptoms, selfefficacy for pain and concomitant care seeking. Participants were randomized to two groups. The intervention group (IG) consists of eight group trainings. Each training had an educational block followed by a physical exercise block supervised by a physical therapist. In addition, motivational text messages were sent to adhere to the exercises. The control group (CG) received an educational booklet in a single consultation. Feasibility rates were described in percentages and absolute numbers. The criteria were defined a priori to set the feasibility. Our results show that 248 older people were recruited, 46 were eligible and 40 were randomized, indicating adequate rates of recruitment and consent. The rate of adherence to the intervention was 60% and partially met the adherence criterion. The rate of adherence to unsupervised exercises was adequate (75%). The retention rate was high in both groups (100% in the IG and 95% in the CG). Regarding the interventions, both the difficulty of understanding the educational component and the difficulty of performing the exercises were small in both groups. Safety to perform exercises was partially met in the IG (70%) and fully met in the CG (94.7%). In addition, 95% of the older adults in the IG reported that text messages motivated them to perform the exercises. Six participants reported adverse events in each group. Positive changes in secondary outcomes reinforce the use of specific measures for older people in clinical trials. Most of the feasibility criteria were fully met. Adherence to the program and the safety to perform the exercises in the IG partially met the feasibility criteria, indicating the need for minor adjustments in the intervention logistics and orientation of the exercises at home. This feasibility study supports the conduct of a full study investigating the effect of the large-scale program on Primary Care. This study is the first step towards making interventions for older people with LBP available in primary care.