A clinical study on Baduanjin exercise alleviating bone pain and improving balance function in patients with primary osteoporosis

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: Patients who meet the inclusion and exclusion criteria will be randomly divided into the control group and the treatment group, with 80 patients in each group. The researchers will entrust a professional data management department to generate random numbers and control data quality. They will use SAS 9.1.2 to generate a random number grouping table according to the number of cases. This form is kept in a safe place by the data management unit. The investigators will be engaged in applying for a random number throughout the trial. According to the group designated by the random number, the clinician accurately records the patient's random number, group, and treatment measures. Before treatment, general physical examination, laboratory tests (blood), and bone mineral density detection will be conducted while the degree of pain and the ability to balance will be scored. During the treatment period, patients in the control group will be given Calcium Carbonate D3 Chewable tablets, its dosage will be 0.6 g/time, two times/day, and orally half an hour after meals. Patients in the treatment group will be given Baduanjin exercise combined with Carbonate D3 Chewable tablets. The intervention lasts 6 months. The requirements for the Baduanjin exercise will be: A) Preparatory stage (the first 2 weeks, familiar with and mastering movement stage): The patients need to concentrate on practising Baduanjin exercise three times a week. The researchers will hire professional coaches to guide and correct the movements. During the rest of the time, the researchers will distribute free videos to practice by themselves at home. B) Implementation stage (the last 22 weeks, regular exercise): CONDITION: Primary osteoporosis ; Musculoskeletal Diseases ; Osteoporosis, unspecified PRIMARY OUTCOME: ; 1. Lower back pain is measured using the visual analogue scale (VAS, 0‐10 points) at baseline, after the 6th month of enrollment, and the 6th month of follow‐up after the end of treatment.; 2. Balance ability is measured using the Berg balance scale (BBS, 0‐56 points) at baseline, after the 6th month of enrollment, and the 6th month of follow‐up after the end of treatment.; INCLUSION CRITERIA: 1. Primary osteoporosis: T‐value of bone density measurement is less than or equal to ‐2.5 2. Female aged from 45 to 70 years old and female menopause time is greater than 2 years, which are met at the same time. Male aged from 50 to 70 years old 3. Visual analogue scale (VAS) is greater than or equal to 3 points 4. Willing to participate in the study SECONDARY OUTCOME: ; 1. Bone mineral density (BMD) is measured using dual‐energy X‐ray absorptiometry (DXA) at baseline, after the 6th month of enrollment, and the 6th month of follow‐up after the end of treatment; 2. Laboratory tests (blood) using Lumine XAssay at baseline, after the 6th month of enrollment, and the 6th month of follow‐up after the end of treatment. The serological indicators include Type I Procollagen N‐terminal Propeptide (P1NP), ß‐collagen Degradation Product (ß‐CTX), Myostatin (MSTN), Fibroblast Growth Factor‐23 (FGF‐23), Neuropeptide Y (NPY).; 3. Fall risk is measured using the timed “up and go” test (TUGT) and morse fall scale (MFS, 0‐125 points) at baseline, after the 6th month of enrollment, and 6th month of follow‐up after the end of treatment; 4. Lower extremity muscle strength is measured using five‐times sit‐to‐stand test (FTSST) at baseline, after the 6th month of enrollment, and the 6th month of follow‐up after the end of treatment;
Epistemonikos ID: aa99833104f8424fb2c504c161e80d048ec8d267
First added on: Aug 25, 2024