Baduanjin With Resistance Training Program for Elderly Patients With Osteoporosis and Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in Quality of life measured by the Oswestry Disability Index (ODI)
研究概览
简要总结
The purpose of this study is to improve symptoms of Lumbar Disc Herniation (LDH) and Osteoporosis (OP) by implementing an evidence-based Baduanjin exercise to reduce pain and increase muscle strength and quality of life in Chinese patients. This study will provide new sights of exercise of elderly patients with LDH and OP for elderly patients.
详细描述
Participants in the control group will continue with their conventional post surgery treatment as follows: comprehensive post-operative care and educational handouts that include guidelines for lumbar and back exercises to improve recovery and promote spinal health. In addition, participants will receive three interactive Q&A sessions before discharge (pre-operation, post-operation, and on the day of discharge). During these sessions, patients can discuss their concerns and ask questions about their recovery.
Participants in the experimental group will continue to receive their conventional post surgery treatment in addition to BDJ as follows: Individual session training (admission to week 1 post-surgery), no training week 2, Group session I (week 3 and 4), Group session 2 (week 5-12) and perform independent exercises during which participants will have to keep an exercise diary (week 13-24).
Data collection will be conducted through in-person visits at baseline and Week 1, followed by phone calls at Week 12 and Week 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with LDH and OP based on the chart and clinical diagnostic criteria.
- •Age of female patients ≥ 45 years，age of male patients ≥ 50 years.
- •Visual analogue scale (VAS) ≥ 3 points.
- •Surgical operation will be performed during the 7-day admission period.
- •Mandarin speakers.
排除标准
- •Severe primary diseases: ulcerative colitis, gastrointestinal bleeding, pancreatitis, lung cancer, pneumonia, acute respiratory distress syndrome or psychosis, depression, anxiety or substance abuse, identified by diagnosis and interview.
- •Current engagement in regular physical activity routines over the past 3 months: aerobic exercises for at least 30 minutes, at least 3 times per week.
- •Taken drugs within 3 months before enrollment: bisphosphonates, glucocorticoids, calcitonin, anticonvulsant drugs, heparin, etc.
研究组 & 干预措施
Control Group
Participants will receive conventional (usual) treatment: continue with their original treatment, medication, and diet habits. After spinal surgery, two nurses trained according to this study protocol will teach participants standard guidance for lumbar and back exercises, which will include exercise suggestions and health education.
BDJ with resistance training
BDJ exercise combined with resistance training and conventional (usual) treatment in the experimental group. Two nurses will provide training to ensure that participants can perform the movements skillfully and coherently.
干预措施: Baduanjin with Resistance Training Program (Behavioral)
结局指标
主要结局
Change in Quality of life measured by the Oswestry Disability Index (ODI)
时间窗: Weeks 0, 1, 12, and 24
ODI is the most widely accepted scales for assessing quality of life and the severity of disability caused by back pain. It assesses the impact of back pain on various daily activities. The ODI is a questionnaire containing 10 items covering disability caused by low back pain. Each item is assessed on a six-level ordinal scale with "0" describing "no limitation" and "5" describing "extreme limitation or an inability to function", with higher values representing a greater extent of disability. The total score is converted to a percentage to determine the severity of disability. Scores are interpreted as follows: 0-20% (minimal disability), 21-40% (moderate disability), 41-60% (severe disability), 61-80% (crippled), and 81-100% (bed-bound or exaggerating symptoms). The Cronbach's alpha of this scale was 0.89.
Change in Muscle strength by the Five Times Sit-to-Stand Test (FTSS)
时间窗: Weeks 0, 1, 12, and 24
The researchers need to record the total time spent going from sit to stand. At last, the test will be performed three times, and the final average in seconds is taken. Each patient was given 2 minutes intervals for rest. The time it takes to complete the five times sit-to-stand test (FTSST) varies by age and gender. Healthy adults complete the test in ≤ 10 seconds; times ≥15 seconds indicate increased fall risk and mobility impairments. The Cronbach alpha 0.99, and the reliability was 0.97.
Change in physical activity level by the International Physical Activity Questionnaire (IPAQ).
时间窗: Weeks 0, 1, 12, and 24
The IPAQ-LC is a widely used tool for assessing physical activity levels in various populations. This scale requires participants to complete 31 questions across four activity domains (transportation, work, household, and leisure time), and includes sections on walking, moderate and vigorous activity, and sedentary behaviors (sitting and lying awake\]. The exercises recorded must last at least 10 minutes each time. To calculate a total activity score, the reported activity is assigned a Metabolic Equivalents (MET) value based on its intensity. (1) Low Activity Level: \<600 MET minutes/ a week; (2) Moderate Activity Level: 600\~3000 MET minutes/ a week; (3) \> 3000 MET minutes/ a week. The Cronbach's alpha of this scale was 0.88.
次要结局
- Change in Exercise self-efficacy by the Self-Efficacy for Exercise Scale (SEE)(Weeks 0, 1, 12, and 24)
- Change in exercise benefit by the Exercise Benefits and Barriers Scale (EBBS)(Weeks 0, 1, 12, and 24)
- Incidence of complications after surgery(Week 1)