Effects of a Multidimensional Exercise and Mindfulness Approach Targeting Physical, Psychological, and Functional Outcomes: Protocol for the BACKFIT Randomized Controlled Trial with an Active Control Group

Introduction: Chronic primary low back pain (CPLBP) is a prevalent condition in primary care and a leading cause of disability and absenteeism worldwide. Multidimensional approaches may be necessary to achieve physical and mental health benefits in individuals with CPLBP. Objective: The BACKFIT randomized controlled trial aims to evaluate the effectiveness of a multidimensional intervention—combining supervised exercise and mindfulness—on pain, physical fitness, mental health, and functional outcomes in individuals with CPLBP. Hypothesis: Both the supervised exercise program focused on motor control and trunk muscle strength (IG1) and the multidimensional intervention combining supervised exercise with mindfulness training (IG2) are expected to produce significant health improvements in individuals with CPLBP. It is further hypothesized that IG2 will yield greater improvements compared to IG1, both immediately post-intervention and at the two-month follow-up. Design. Randomized controlled trial. Setting: Virgen de las Nieves University Hospital, Granada (Spain). Participants: 105 individuals. Inclusion criteria: Previously diagnosed with CPLBP, aged ≥18 and ≤65 years, able to read and understand the informed consent, and able to walk, move, and communicate without external assistance. Exclusion criteria: serious lumbar structural disorders, acute or terminal illness, physical injury, mental illness, and medical prescriptions that prevent participation in the study. Intervention: Individuals will be randomly assigned to a supervised physical exercise group (2 days per week, 45 min per session), a multidimensional intervention group (same as supervised physical exercise group, and mindfulness 1 day per week, 2.5 h per session) or an active control group (usual care, 2 days per week, 45 min per session). The intervention will last 8 weeks. Main Outcome Measures: Primary outcome: pain threshold, perceived acute pain, and disability due to pain. Secondary measures: body composition, muscular fitness, gait parameters, device-measured physical activity and sedentary behavior, self-reported sedentary behavior, quality of life, pain catastrophizing, mental health, sleep duration and quality, and central sensitization. The groups will undergo pre-intervention, post-intervention, and a 2-month follow-up after a detraining period. Statistical Analysis: Both per-protocol and intention-to-treat approaches (≥70% attendance) will be used. Program effects will be assessed via one-way ANCOVA for between-group changes in primary and secondary outcomes. Conclusions: Given the complex nature of CPLBP, multidimensional approaches are recommended. If effective, this intervention may provide low-cost alternatives for health professionals.