A four-arm randomized controlled trial comparing different weekly frequencies of Baduanjin exercise versus usual daily activities on balance, bone mineral density and quality of life in patients with primary osteoporosis
Primary osteoporosis
This is a four-arm, parallel-group, randomised, single-blind assessor-blinded controlled trial. A total of 168 participants with primary osteoporosis will be randomly allocated in a 1:1:1:1 ratio to one of four groups: (1) high-frequency Baduanjin group: supervised Baduanjin exercise 5 sessions per week, at least 60 minutes per session; (2) medium-frequency Baduanjin group: supervised Baduanjin exercise 3 sessions per week, at least 60 minutes per session; (3) low-frequency Baduanjin group: supervised Baduanjin exercise 1 session per week, at least 60 minutes per session; (4) control group: usual daily activities without structured Baduanjin exercise. The randomisation sequence will be generated by an independent statistician using R software, version 4.5.1. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared according to the randomisation sequence. The envelopes will be opened only after completion of baseline assessment and confirmation of participant eligibility. Outcome assessors will remain blinded to group allocation. Participants in the Baduanjin groups will practise the official “Health Qigong · Baduanjin” programme issued by the General Administration of Sport of China. The sessions will be delivered as supervised group-based exercise sessions at the participating study centres by certified Baduanjin/Health Qigong instructors. Each session will include a 5-10 minute warm-up, 30-45 minutes of main Baduanjin practice, and a 5-10 minute cool-down. Exercise intensity will be controlled at a Borg Rating of Perceived Exertion of 11-13. The intervention will last for 6 months, followed by a 3-month follow-up period. Attendance at each supervised session will be recorded using a Baduanjin exercise log, and adherence will be calculated as the number of completed sessions divided by the number of planned sessions. Adverse events will be recorded throughout the study by active questioning and spontaneous reporting.
1. Diagnosis of primary osteoporosis (DXA T-score ≤ -2.5 at lumbar spine, total hip or femoral neck, or presence of a hip/vertebral fragility fracture) 2. Aged 50–79 years, any sex 3. Berg Balance Scale score between 22 and 51 4. Able to give informed consent and voluntarily participate
1. Secondary osteoporosis (e.g., due to hyperparathyroidism, long-term glucocorticoid use, rheumatoid arthritis, etc.) 2. Use of anti-osteoporosis prescription medication (bisphosphonates, denosumab, teriparatide, selective estrogen receptor modulators, etc.) within 6 months prior to enrolment 3. Severe or unstable cardiovascular, respiratory or neurological disease (e.g., uncontrolled hypertension ≥ 160/100 mmHg, heart failure, stroke sequelae) 4. Severe knee, hip or spinal conditions that prevent standing or slow walking (e.g., severe osteoarthritis, acute lumbar disc herniation, spinal deformity) 5. Fragility fracture or orthopaedic surgery within the last 3 months 6. Pregnancy, breastfeeding, or planning to become pregnant within the next year 7. Currently engaged in regular exercise (moderate-intensity or above, ≥3 times per week, ≥30 minutes each session, including Baduanjin, Tai Chi, brisk walking, jogging, etc.) 8. Concurrent participation in another clinical trial that may affect balance or bone metabolism, or participation in another interventional clinical trial within the last 3 months 9. Unable to use a smartphone (if required for follow-up reminders or questionnaires) 10. Any factors that may limit adherence to follow-up, such as plan to leave the local area for a long time, alcohol or substance abuse, dementia or cognitive impairment