Effects of Tailored Mindful Exercise on Back Pain, Balance, Kinesiophobia, Anxiety and Depression in Older Patients with Primary Osteoporosis: A Randomized Controlled Trial

Exercise has known benefits for bone, physical, and mental health. This study aimed to determine the effects of a tailored mindful exercise program on back pain, balance, kinesiophobia, mindfulness, anxiety, and depression in older patients with primary osteoporosis. A two-arm randomized controlled trial (RCT) was conducted in a hospital setting in Kunming, China. Eligible patients were recruited and randomized to either an intervention group (Mindful Exercise) or a control group (Usual Care). Outcomes—back pain (Global Pain Scale, GPS), balance (Timed Up and Go test, TUG), mindfulness (Five Facet Mindfulness Questionnaire-Short Form, FFMQ-SF), kinesiophobia (Tampa Kinesiophobia-11 Scale, TSK-11), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) were assessed at baseline (pre-intervention), Week 4 (in-process), Week 8 (in-process), Week 12 (immediately post-intervention) and Week 16 (4 weeks post-intervention). Data were analyzed using the generalized estimating equation (GEE) model. Immediately post-intervention (Week 12), the intervention group showed statistically significant improvement in pain [B = -1.782, 95% CI (-2.128, -1.436), Cohen's d = -0.47] and feeling [B = -2.864, 95% CI (-3.228, -2.500), Cohen's d = -0.36] dimensions of the GPS, balance [B = -0.936, 95% CI (-1.611, -0.260), Cohen's d = -0.37], mindfulness [B = 4.293, 95% CI (3.506, 5.079), Cohen's d = 0.89], kinesiophobia [B = -3.863, 95% CI (-4.300, -3.425), Cohen's d = -0.40], anxiety [B = -1.774, 95% CI (-2.136, -1.411), Cohen's d = -0.43] and depression [B = -1.331, 95% CI (-1.581, -1.081), Cohen's d = -0.40] compared with the control group. The tailored mindful exercise program reduced pain severity and a wide array of psychological symptoms and improved mindfulness levels among older patients with primary osteoporosis. These significant improvements underscore the program's potential as a valuable clinical intervention for this population. https://www.clinicaltrials.gov ; Unique Identifier: NCT05606510.