BACKGROUND: Exercise has shown being effective for managing chronic pain and preventing frailty status in older adults but the effect of an exercise program in the quality of life of pre-frail older adults with chronic pain remains unclear. Our objective was to evaluate the effectiveness of multicomponent structured physical exercise program for pre-frail adults aged 65 years or more with chronic pain to improve their perceived health related quality of life, compared with usual care. METHODS: Open label randomized controlled trial. Participants were community-dwelling pre-frail older adults aged 65 years or older with chronic pain and non-dependent for basic activities of daily living attending a Primary Healthcare Centre. Forty-four participants were randomly allocated to a control group (n = 20) that received usual care or an intervention group (n = 24) that received an 8-week physical activity and education program. Frailty status (SHARE Frailty Index), quality of life (EuroQol-5D-5L), pain intensity (visual analogue scale), physical performance (Short Physical Performance Battery) and depression (Yessavage) were assessed at baseline, after the intervention and after 3 months follow-up. The effect of the intervention was analysed by mean differences between the intervention and control groups. RESULTS: The follow-up period (3 months) was completed by 32 patients (73%), 17 in the control group and 15 in the intervention group. Most participants were women (78.1%) with a mean age (standard deviation) of 77.2 (5.9) years and a mean pain intensity of 48.1 (24.4) mm. No relevant differences were found between groups at baseline. After the intervention, mean differences in the EuroQol index value between control and intervention groups were significant (-0.19, 95% CI -0.33 to -0.04) and remained after 3 months follow-up (-0.21, 95% CI -0.37 to -0.05). Participants in the exercise group showed better results in pain intensity and frailty after the intervention, and an improvement in physical performance after the intervention and after 3 months. CONCLUSIONS: An eight-week physical activity and education program for pre-frail older adults with chronic pain, compared with usual care, could be effective to improve quality of life after the intervention and after three-months follow-up. STUDY REGISTRATION DETAILS: This study was retrospectively registered in ClinicalTrials.gov with the identifier NCT04045535.

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