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Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II
Sponsor: Xuanwu Hospital, Beijing
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.
Official title: Multimodal Physiological Reserve Optimizing Prehabilitation Program (PHYSIO-Prehab) in the Chinese Elderly With Spine Surgery
Key Details
Gender
All
Age Range
75 Years - Any
Study Type
INTERVENTIONAL
Enrollment
248
Start Date
2026-04-25
Completion Date
2027-12-30
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
Multimodal 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.
Usual 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.