NCT07623304

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Jan 2024Jun 2028

Study Start

First participant enrolled

January 1, 2024

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

May 28, 2026

Last Update Submit

May 28, 2026

Conditions

Clinical Decision Support System

Outcome Measures

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.

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

Secondary Outcomes (3)

  • RPE Score

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

  • NRS Score

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

  • SUS Score

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

Study Arms (2)

The intervention group

EXPERIMENTAL

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 fracturesBehavioral: Basic Postoperative Care

The control group

ACTIVE COMPARATOR

The control group received conventional postoperative care interventions

Behavioral: Basic Postoperative CareBehavioral: Conventional Postoperative Care

Interventions

Basic Postoperative CareBEHAVIORAL

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

The control groupThe intervention group
Conventional Postoperative CareBEHAVIORAL

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.

The control group
Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fracturesBEHAVIORAL

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.

The intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated 2 Hospital of Nantong University, Nantong, Jiangsu 0513

Nantong, Jiangsu, China

RECRUITING

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Hong GAO

CONTACT

137736433152439220393@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 3, 2026

Study Start

January 1, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)