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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorXuanwu Hospital, Beijing

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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])

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multimodal physiological reserve optimizing prehabilitation program

    Other intervention

    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

    Other intervention

    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.

Treatment groups

248 Participants
are divided into 2 treatment groups
Group A: PHYSIO-Prehab groupExperimental treatment 1 intervention
Group B: Usual care groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Barthel ADL Index from baseline to 30 days postoperatively

Primary efficacy outcome

Time frame
Within 30 days after surgery
2

30-day postoperative Comprehensive Complication Index

The proportion of participants with a Comprehensive Complication Index \> 20

Time frame
Within 30 days after surgery

Secondary outcomes

1

Change in Barthel ADL Index from baseline to 90 days postoperatively

Time frame
Within 90 days after surgery
2

90-day Barthel ADL Index postoperatively

Time frame
Within 90 days after surgery
3

30-day Barthel ADL Index postoperatively

Time frame
Within 30 days after surgery
4

30-day postoperative Comprehensive Complication Index

Time frame
Within 30 days after surgery

Other outcomes

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