Primary Osteoporosis clinical trials

The Effects of Mindful Exercise on Back Pain in Older Patients With Primary Osteoporosis

The goal of this randomized control trial is to determine the effects of a mindful exercise program on physical (back pain and balance) and psychological (mindfulness, kinesiophobia, anxiety and depression) consequences of primary osteoporosis in older patients. The main questions it aims to answer are: - What are the levels of pain, balance, mindfulness, kinesiophobia, anxiety and depression in older patients with primary osteoporosis? - Are there differences in pain, balance, mindfulness, kinesiophobia, anxiety and depression according to sociodemographic-clinical characteristics of the patients? - Are there differences in pain, balance, mindfulness, kinesiophobia, anxiety and depression between the intervention (mindful exercise) and control (usual care) groups of older patients with primary osteoporosis? 128 participants who meet the criteria will be recruited from the pain department of a Tertiary A level provincial Traditional Chinese Medicine hospital in Mainland China, and randomly assigned to the intervention group or control group. All patients in both groups will receive usual care, including routine medicine and nursing care. The study will last for 12 weeks (one-week training in hospital and 11-week on-line sessions at home) and 4-week follow up. Patients in the intervention group will receive a group-based mindful exercise which will be conducted 5 times per week, 30 minutes per session, and co-led by a mindfulness-trained main researcher and a professional exercise specialist for the first week (week 1) hospitalization. When they discharge, on-line sessions (week 2-12) will be conducted by the main researcher from Monday to Friday. Patients and primary caregivers will be taught how to use 'Tencent meet' software. Upon discharge, a WeChat group will be set up to notify the exercise time and send the links for the online sessions. Those in the control group will received routine medicine and nursing care as usual, and only be taught on the hospital-recommended movements (physical stretching) and encouraged to do it at home on their own. All the variables (pain, mindfulness, kinesiophobia, anxiety and depression) and the TUG test (balance) will be measured at the following time point: baseline (Time 1), week 4 (Time 2), week 8 (Time 3), week 12 (Time 4, immediately post-intervention) and week 16 (Time 5, 4 weeks after the intervention) for the two groups of patients. The study will obtain ethical clearance from the study setting, as well as written consent from the participants. Descriptive statistics will be computed for all variables. Normality and homogeneity of the variances will be tested using the Shapiro-Wilk and Levene tests, respectively. The data will be analyzed using mixed-model analysis of variance to test the main and interaction effects of group (independent factor) and time (repeated-measures factor) on the dependent variables. The findings of the study would certainly have implications for the treatment of older patients with primary osteoporosis, especially non-pharmacological treatment.