RecruitingNot ApplicableNCT07396077

Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II

Multimodal Physiological Reserve Optimizing Prehabilitation Program (PHYSIO-Prehab) in the Chinese Elderly With Spine Surgery

Sponsor

Xuanwu Hospital, Beijing

Enrollment

248 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

Prehabilitation Frail Elderly Lumbar Degenerative Disease Spine Degeneration Enhanced Recovery After Surgery (ERAS) Protocol

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.

Eligibility

Min Age: 75 Years

Inclusion Criteria6

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 Criteria7

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°)
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

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Interventions

OTHERMultimodal physiological reserve optimizing prehabilitation program

The PHYSIO-Prehab program features targeted multimodality integration, addressing the unmet need for surgery-specific preoperative interventions in elderly lumbar fusion patients. Its innovations lie in three aspects: first, it combines supervised group sessions with home-based exercise, balancing professional guidance and practical feasibility, and adjusts intensity via the Borg 10-point scale to fit individual tolerance. Second, it goes beyond conventional prehabilitation by integrating nutritional optimization, comorbidity management and cognitive prehabilitation, targeting physiological reserve deficits and frailty-related risks. Third, it is tailored to lumbar spinal disease characteristics, optimizing exercise modalities to avoid lumbar burden, which overcomes the limitations of general frailty interventions and enhances relevance to surgical recovery needs.

OTHERUsual Care

Both groups will receive consistent perioperative ERAS care implemented by the orthopedic department since January 2019, including multimodal and preemptive analgesia, inspiratory muscle training, minimal intravenous fluid administration, early urinary tube removal, avoidance of mechanical bowel preparation, no prolonged fasting, and antithrombotic prophylaxis.