Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spi… (NCT07396077) | Clinical Trial Compass
RecruitingNot Applicable
Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II
China248 participantsStarted 2026-04-15
Plain-language summary
This multicenter, parallel-group, assessor-blinded randomized controlled trial will enroll 248 adults aged ≥75 years with degenerative lumbar spinal diseases scheduled for elective lumbar fusion surgery, and they will be randomized 1:1 into the intervention and usual care groups. The intervention group will receive a 6-week PHYSIO-Prehab multimodal prehabilitation program, including multicomponent exercise, nutritional intervention, comorbidity optimization, and cognitive prehabilitation with brain protection strategies. The control group will receive standard health education provided via a manual, and both groups will receive consistent perioperative Enhanced Recovery After Surgery care. The primary outcome will be the change in Barthel Index (a tool for assessing independence in activities of daily living) from baseline to 30 days postoperatively; secondary outcomes will include pain scores, disability, patient satisfaction, and the 30-day postoperative Comprehensive Complication Index. The trial will initiate recruitment in April 2026 and conclude in December 2027, aiming to evaluate the feasibility and efficacy of PHYSIO-Prehab and provide high-quality evidence for patient-centered perioperative care pathways in this population.
Who can participate
Age range75 Years
SexALL
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Inclusion criteria
✓. Aged ≥75 years at the time of screening
✓. Voluntarily sign the informed consent form
✓. Clinically diagnosed with degenerative lumbar spinal disorders with duration of symptoms \>6 months
✓. Requiring elective lumbar fusion surgery (single-level or multi-level, open or minimally invasive approach)
✓. No severe cognitive impairment (Mini-Mental State Examination score \> 9)
✓. Scheduled to undergo surgery within 6-8 weeks after screening (allowing completion of the 6-week prehabilitation program)
Exclusion criteria
✕. Scheduled to undergo other emergency surgery or day surgery
✕. Urgent medical conditions requiring priority management before spinal surgery
✕. With spinal disorders other than degenerative diseases (spinal fracture, tumor, metastasis, infection, ankylosing spondylitis, scoliosis with Cobb angle \>40°)
What they're measuring
1
Change in Barthel ADL Index from baseline to 30 days postoperatively
Timeframe: Within 30 days after surgery
2
30-day postoperative Comprehensive Complication Index
✕. With contraindications to prehabilitation exercise (New York Heart Association Class IV heart failure, unstable angina, uncontrolled hypertension \[systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg despite medication\])
✕. With severe functional disability for other disorders or long-term bedridden status unable to perform basic physical activities
✕. With allergy or intolerance to nutritional supplements used in the prehabilitation program
✕. Participating in another clinical trial involving prehabilitation, perioperative intervention, or spinal surgery within 3 months before screening