Development and Application of a Clinical Decision Support System for Exercise Rehabilitation in Patients With Osteoporotic Vertebral Compression Fractures
28 maj 2026 uppdaterad av: Jiawei Jiang
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.
Studieöversikt
Status
Rekrytering
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Hong Gao
- Telefonnummer: 13773643315
- E-post: 2439220393@qq.com
Studieorter
-
-
Jiangsu
-
Nantong, Jiangsu, Kina
- Rekrytering
- Affiliated 2 Hospital of Nantong University, Nantong, Jiangsu 0513
-
Huvudutredare:
- Hongqing Xu, Dr
-
Kontakt:
- Hong Gao
- Telefonnummer: 13773643315
- E-post: 2439220393@qq.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Kontrollgruppen
Kontrollgruppen fick konventionella postoperativa vårdinsatser
|
Alla deltagare instruerades att upprätthålla sin vanliga dagliga aktiviteter och avstå från ytterligare behandlingar under 6-månaders studieperioden.
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.
|
|
Experimentell: 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.
|
Alla deltagare instruerades att upprätthålla sin vanliga dagliga aktiviteter och avstå från ytterligare behandlingar under 6-månaders studieperioden.
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
IPAQ-L Scores
Tidsram: The 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.
|
The IPAQ-L scores were collected at baseline and at 3 months, and 6 months post-intervention.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
RPE Score
Tidsram: The 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.
|
The RPE scores were collected at baseline and at 3 months, and 6 months post-intervention.
|
|
NRS Score
Tidsram: The 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.
|
The NRS scores were collected at baseline and at 3 months, and 6 months post-intervention.
|
|
SUS Score
Tidsram: The 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.
|
The SUS scores were collected at baseline and at 3 months, and 6 months post-intervention.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2024
Primärt slutförande (Beräknad)
1 januari 2028
Avslutad studie (Beräknad)
1 juni 2028
Studieregistreringsdatum
Först inskickad
28 maj 2026
Först inskickad som uppfyllde QC-kriterierna
28 maj 2026
Första postat (Faktisk)
3 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HGao
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .