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Recruiting NCT07623304

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

No phase Interventional Clinical Decision Support System

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures, Basic Postoperative Care, Conventional Postoperative Care.
Who it may be relevant to
Registry conditions: Clinical Decision Support System. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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
  • 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.

Primary outcome measures

  • IPAQ-L Scores [Time frame: The IPAQ-L scores were collected at baseline and at 3 months, and 6 months post-intervention.]
Secondary outcome measures (3)
  • RPE Score [Time frame: The RPE scores were collected at baseline and at 3 months, and 6 months post-intervention.]
  • NRS Score [Time frame: The NRS scores were collected at baseline and at 3 months, and 6 months post-intervention.]
  • SUS Score [Time frame: The SUS scores were collected at baseline and at 3 months, and 6 months post-intervention.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Affiliated 2 Hospital of Nantong University, Nantong, Jiangsu 0513 — Nantong

Identifiers

NCT: NCT07623304 · HGao

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗