Development and Application of a Clinical Decision Support System for Exercise Rehabilitation in Patients With Osteoporotic Vertebral Compression Fractures
2026年5月28日 更新者：Jiawei Jiang
This study aims to develop a clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures, based on evidence-based recommendations for postoperative exercise rehabilitation.
The system is designed to provide individualized assessment and exercise interventions, monitor exercise behaviors, and deliver risk alerts, thereby promoting safe and standardized postoperative exercise training in OVCF patients.
The ultimate objectives are to evaluate the feasibility and effectiveness of the system in increasing physical exercise participation, reducing sedentary time, and facilitating postoperative rehabilitation, without increasing fatigue or pain.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Hong Gao
- 电话号码：13773643315
- 邮箱：2439220393@qq.com
学习地点
-
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Jiangsu
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Nantong、Jiangsu、中国
- 招聘中
- Affiliated 2 Hospital of Nantong University, Nantong, Jiangsu 0513
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首席研究员：
- Hongqing Xu, Dr
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接触：
- Hong Gao
- 电话号码：13773643315
- 邮箱：2439220393@qq.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- age between 18 and 55 years
- diagnosis of lumbar disc herniation requiring single-level lumbar fusion surgery - no previous history of lumbar surgery
- Surgical procedures performed by the same surgical team
- willingness to comply with the study protocol and restrictions
- availability of a home WiFi connection
Exclusion Criteria:
- lumbar surgery secondary to neoplasm, tuberculosis, infection, or inflammation
- postoperative infection or revision surgery
- presence of cauda equina syndrome
- diagnosis of schizophrenia, cognitive impairment, or other psychiatric disorders
- coexisting severe cardiovascular or cerebrovascular diseases, or congenital conditions precluding exercise participation.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：对照组
对照组接受了常规的术后护理干预措施
|
在整个6个月的研究期间，所有参与者都被指示维持其通常的日常活动，并戒除其他治疗方法。
Before discharge, patients received exercise rehabilitation training guidance from orthopedic specialist nurses and rehabilitation therapists and were given a rehabilitation training manual.
They were instructed to scan the QR code in the manual to watch exercise training videos.
The manual contained information including the goals, methods, frequency, intensity, and precautions of the exercise training.
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实验性的：The intervention group
The experimental group received individualized assessment and exercise rehabilitation intervention through the clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures.
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在整个6个月的研究期间，所有参与者都被指示维持其通常的日常活动，并戒除其他治疗方法。
The experimental group first developed the functional modules of the OVCF exercise rehabilitation decision support system.
Researchers were trained on participant selection, module use, and task allocation.
Participants received operation demonstrations and a QR code for video guidance, then registered accounts and entered data.
The system auto-captured baseline indicators, generated individualized exercise prescriptions, and pushed them for staff approval.
Before and after each exercise session, patients completed vital signs, pain, and fatigue assessments; the system analyzed these data, generated decision support, and recommended next steps for therapist review.
Data management included visualization, click tracking, and identification of low compliance, triggering individual online support.
A user group facilitated communication.
At follow-ups, osteoporosis clinic staff reviewed personal information and adjusted prescriptions based on exercise experience and outcomes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
IPAQ-L Scores
大体时间：The IPAQ-L scores were collected at baseline and at 3 months, and 6 months post-intervention.
|
Physical activity levels were assessed using the Chinese version of the International Physical Activity Questionnaire-Long (IPAQ-L) adapted by Qu Ningning et al.
The questionnaire comprises 27 items across six domains: work, transportation, domestic activities, exercise and recreation, sitting time, and sleep time.
Each domain includes physical activities at high, moderate, and low intensities.
Based on the number of days and accumulated time per day of activity in the past week, weekly physical activity energy expenditure was calculated and expressed in metabolic equivalents (METs).
The test-retest reliability (r=0.927) and criterion validity (r=0.821) of this questionnaire are higher than or equal to those of comparable instruments.
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The IPAQ-L scores were collected at baseline and at 3 months, and 6 months post-intervention.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
RPE Score
大体时间：The RPE scores were collected at baseline and at 3 months, and 6 months post-intervention.
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Fatigue was assessed using the Borg Rating of Perceived Exertion (RPE) , a subjective tool for evaluating exercise intensity developed by Swedish psychologist Gunnar Borg, designed to quantify an individual's perception of physical exertion during exercise.
On the scale, 6 represents no exertion at all; 7-8 indicates extremely light exertion (e.g.sitting quietly); 9-10, very light; 11-12, light exertion; 13-14, moderate exertion; 15-16, heavy exertion; 17-18, very heavy exertion; and 19-20, extremely exhausting, approaching maximal exertion.
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The RPE scores were collected at baseline and at 3 months, and 6 months post-intervention.
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NRS Score
大体时间：The NRS scores were collected at baseline and at 3 months, and 6 months post-intervention.
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Postoperative pain was assessed using the Numerical Rating Scale (NRS), with a total score ranging from 0 to 10, where 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, 7-9 indicates severe pain, and 10 indicates excruciating pain.
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The NRS scores were collected at baseline and at 3 months, and 6 months post-intervention.
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SUS Score
大体时间：The SUS scores were collected at baseline and at 3 months, and 6 months post-intervention.
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Usability was evaluated using the System Usability Scale (SUS) [15-16], which consists of 10 items rated on a 5-point Likert scale, with 1 representing "strongly disagree" and 5 representing "strongly agree."
For odd-numbered items, the item score is the response score minus 1; for even-numbered items, the item score is 5 minus the response score.
If an item is left blank, it is assigned a score of 3. The sum of the 10 item scores is multiplied by 2.5 to yield the final SUS score, which ranges from 0 to 100.
A score above 60 indicates acceptable usability, ≥70 indicates good usability, ≥80 indicates very good usability, and ≥90 indicates excellent usability.
The Cronbach's α coefficient of the scale was 0.91.
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The SUS scores were collected at baseline and at 3 months, and 6 months post-intervention.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年1月1日
初级完成 (估计的)
2028年1月1日
研究完成 (估计的)
2028年6月1日
研究注册日期
首次提交
2026年5月28日
首先提交符合 QC 标准的
2026年5月28日
首次发布 (实际的)
2026年6月3日
研究记录更新
最后更新发布 (实际的)
2026年6月3日
上次提交的符合 QC 标准的更新
2026年5月28日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.