NCT07396077

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Degenerative lumbar spinal diseases are a leading cause of pain, disability, and reduced quality of life among older adults. As the global population ages rapidly, the volume of elderly patients undergoing elective lumbar fusion surgery will rise significantly. However, this cohort will face elevated risks of postoperative complications and delayed recovery of independence in activities of daily living, due to age-related decline in physiological reserve and multiple comorbidities. Enhanced Recovery After Surgery programs have shown value in reducing complications and accelerating recovery, but most focus on intraoperative and postoperative care, lacking targeted preoperative interventions for older adults with frailty or impaired physical function. Prehabilitation, a proactive preoperative strategy to enhance functional capacity and resilience to surgical stress, holds potential for improving postoperative outcomes, yet high-quality randomized trials in lumbar spinal surgery remain scarce. The PRACTICE-2 trial will address this evidence gap by evaluating a tailored multimodal prehabilitation program (PHYSIO-Prehab) for this specific population. This multicenter, parallel-group, assessor-blinded randomized controlled trial will enroll 248 adults aged ≥75 years with degenerative lumbar spinal diseases who are scheduled for elective lumbar fusion surgery. Eligible patients will be randomized at a 1:1 ratio into the intervention group and the usual care group via stratified block randomization, with stratification by frailty status (frail vs. prefrail/non-frail) and participating center to balance key prognostic factors. The intervention group will receive a 6-week PHYSIO-Prehab program, consisting of 3 biweekly supervised group sessions (90 minutes each, including 60 minutes of lectures and 30 minutes of group discussion), plus home-based multicomponent exercise (resistance, balance, aerobic, and stretching training; 3 non-consecutive full sessions per week, with low-intensity walking on other days, adjusted based on the Borg 10-point scale). Additional interventions will include nutritional optimization (based on Mini Nutritional Assessment scores), comorbidity management (targeting anemia, hypertension, and diabetes), and cognitive prehabilitation with brain protection measures. The control group will receive standard health education provided via a manual, and both groups will receive consistent perioperative Enhanced Recovery After Surgery care as implemented by the participating hospitals. The primary efficacy outcome will be the change in Barthel Index of Activities of Daily Living (0-20 points, with higher scores indicating better independence in basic daily activities such as feeding, dressing, and mobility) from baseline to 30 days postoperatively. Secondary efficacy outcomes will include the proportion of patients achieving full independence in activities of daily living (Barthel Index of Activities of Daily Living = 20) at 30 days postoperatively, Numeric Rating Scale scores for back and leg pain, Oswestry Disability Index, and patient satisfaction assessed via the 4-point North American Spine Society scale. The primary safety outcome will be the occurrence of severe or multiple complications, defined as a Comprehensive Complication Index greater than 20 within 30 days postoperatively. Secondary safety outcomes will include primary and total hospital length of stay, non-home discharge, and unplanned readmissions within 30 days postoperatively. The trial will initiate recruitment in April 2026, conclude in December 2027, and use R software for statistical analysis under a modified intention-to-treat principle, aiming to provide high-quality evidence for optimizing patient-centered perioperative care pathways for older adults undergoing lumbar fusion surgery.

Conditions

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

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2026-04-25
• Primary completion: 2027-12-01
• Completion: 2027-12-30
• First posted: 2026-02-09
• Last updated: 2026-02-09