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

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.

Study Overview

• Status: Recruiting
• Conditions: Clinical Decision Support System
• Intervention / Treatment: Behavioral: Basic Postoperative Care; Behavioral: Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures; Behavioral: Conventional Postoperative Care

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hong Gao; Phone Number: 13773643315; Email: 2439220393@qq.com

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China
      • Recruiting
      • Affiliated 2 Hospital of Nantong University, Nantong, Jiangsu 0513
      • Principal Investigator: Hongqing Xu, Dr
      • Contact: Hong Gao; Phone Number: 13773643315; Email: 2439220393@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The control group; The control group received conventional postoperative care interventions	Behavioral: Basic Postoperative Care; All participants were instructed to maintain their usual daily activities and abstain from additional treatments throughout the 6-month study period.; Behavioral: Conventional Postoperative Care; 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.
Experimental: 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.	Behavioral: Basic Postoperative Care; All participants were instructed to maintain their usual daily activities and abstain from additional treatments throughout the 6-month study period.; Behavioral: Decision 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPAQ-L Scores	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.	The IPAQ-L scores were collected at baseline and at 3 months, and 6 months post-intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RPE Score	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.	The RPE scores were collected at baseline and at 3 months, and 6 months post-intervention.
NRS Score	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.	The NRS scores were collected at baseline and at 3 months, and 6 months post-intervention.
SUS Score	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.	The SUS scores were collected at baseline and at 3 months, and 6 months post-intervention.

Collaborators and Investigators

• Sponsor: Jiawei Jiang

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Exercise Therapy
• Other Study ID Numbers: HGao

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No