Skip to content

Development and Application of a Clinical Decision Support System for Exercise Rehabilitation in Patients With Osteoporotic Vertebral Compression Fractures

Development and Application of a Clinical Decision Support System for Exercise Rehabilitation in Patients With Osteoporotic Vertebral Compression Fractures

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07623304
Enrollment
60
Registered
2026-06-03
Start date
2024-01-01
Completion date
2028-06-01
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Decision Support System

Brief summary

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.

Interventions

BEHAVIORALDecision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures

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.

All participants were instructed to maintain their usual daily activities and abstain from additional treatments throughout the 6-month study period.

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.

Sponsors

Jiawei Jiang
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
IPAQ-L ScoresThe 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.

Secondary

MeasureTime frameDescription
RPE ScoreThe RPE scores were collected at baseline and at 3 months, and 6 months post-intervention.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.
NRS ScoreThe NRS scores were collected at baseline and at 3 months, and 6 months post-intervention.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.
SUS ScoreThe SUS scores were collected at baseline and at 3 months, and 6 months post-intervention.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.

Countries

China

Contacts

CONTACTHong GAO
2439220393@qq.com13773643315

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026