CClinicalTrials.gg
RecruitingNCT07623304Updated Jun 3, 2026

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

An interventional study of Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures and Basic Postoperative Care in Clinical Decision Support System, sponsored by Jiawei Jiang. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Jiawei Jiang · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Jan 2024, registered May 2026).
  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Clinical Decision Support System
03

In context

Lead sponsor

Jiawei Jiang is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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: Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures · Behavioral: Basic Postoperative Care

  • Active comparator
    The control group

    The control group received conventional postoperative care interventions

    Behavioral: Basic Postoperative Care · Behavioral: Conventional Postoperative Care

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.

  • BehavioralBasic Postoperative Care

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

  • BehavioralConventional 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: The IPAQ-L scores were collected at baseline and at 3 months, and 6 months post-intervention.

Secondary outcomes

  1. 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.

    Time frame: The RPE scores were collected at baseline and at 3 months, and 6 months post-intervention.

  2. 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.

    Time frame: The NRS scores were collected at baseline and at 3 months, and 6 months post-intervention.

  3. 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.

    Time frame: The SUS scores were collected at baseline and at 3 months, and 6 months post-intervention.

07

Study locations

1 of 1 sites recruiting
  • Affiliated 2 Hospital of Nantong University, Nantong, Jiangsu 0513
    Nantong, Jiangsu, China
    • Hong Gao · Contact · 2439220393@qq.com · 13773643315
    • Hongqing Xu, Dr · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07623304
Lead sponsor
Jiawei Jiang
Responsible party
Jiawei Jiang (Attending Physician, Affiliated 2 Hospital of Nantong University) — Sponsor-investigator
First posted
Jun 3, 2026
Start date
Jan 1, 2024
Primary completion
Jan 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Jun 3, 2026

Study contacts

Hong GAO
Contact
2439220393@qq.com
13773643315

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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