RT journal article
T1 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
A1 Donoso, Belén
A1 Tsiarleston, Gavriella
A1 Castellote-Caballero, Yolanda
A1 Villegas-Fuentes, Alba
A1 Gil-Gutiérrez, Yolanda María
A1 Fernández-Álvarez, José Enrique
A1 Montes, Santiago
A1 Delgado Fernández, Manuel
A1 Mesa-Ruíz, Antonio Manuel
A1 Molina-Garcia, Pablo
A1 Pozuelo-Calvo, Rocío
A1 Membrilla-Mesa, Miguel David
A1 Segura Jiménez, Víctor
A2 Didáctica de la Educación FísicaPlástica y Musical
K1 physical fitness
K1 impairment
K1 mindfulness
K1 non-specific chronic low back pain
K1 exercise
K1 resistance training
K1 randomized controlled trial
AB 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.
PB MDPI
SN 2227-9032
YR 2025
FD 2025-08-20
LK http://hdl.handle.net/10498/37857
UL http://hdl.handle.net/10498/37857
LA eng
DS Repositorio Institucional de la Universidad de Cádiz
RD 21-sep-2026