Pre-surgery preparation program for older adults having lumbar fusion
Multimodal Physiological Reserve Optimizing Prehabilitation Program (PHYSIO-Prehab) in the Chinese Elderly With Spine Surgery
This trial will try a 6-week multimodal prehabilitation program to help people aged 75 and older having elective lumbar fusion recover independence and reduce complications after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 4 sites (Beijing, Beijing Municipality and 3 other locations) |
| Trial ID | NCT07396077 on ClinicalTrials.gov |
What this trial studies
PRACTICE-2 is a multicenter, parallel-group, assessor-blinded randomized trial enrolling 248 adults aged 75 and older scheduled for elective lumbar fusion for degenerative lumbar disease. Participants are randomized 1:1 to a 6-week PHYSIO-Prehab multimodal program—comprising multicomponent exercise, nutritional support, comorbidity optimization, and cognitive prehabilitation—or to usual care with standard health education, and all participants receive the same perioperative ERAS pathway. The primary outcome is change in Barthel Index from baseline to 30 days after surgery; secondary outcomes include pain, disability, patient satisfaction, and 30-day complications. The trial tests whether improving physiological reserve before surgery speeds recovery of activities of daily living in frail elderly surgical candidates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 75 or older with degenerative lumbar spinal disease scheduled for elective single- or multi-level lumbar fusion who can complete a 6-week prehabilitation program and have no severe cognitive impairment.
Not a fit: Patients with urgent surgical needs, non-degenerative spinal conditions, severe cardiac contraindications to exercise, or who cannot complete the 6-week program are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could help frail older patients regain independence faster and lower early postoperative complications after lumbar fusion.
How similar studies have performed: Enhanced Recovery After Surgery approaches have reduced complications in many surgical fields and prehabilitation shows promise, but high-quality randomized trials specifically in elderly lumbar fusion patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged ≥75 years at the time of screening 2. Voluntarily sign the informed consent form 3. Clinically diagnosed with degenerative lumbar spinal disorders with duration of symptoms \>6 months 4. Requiring elective lumbar fusion surgery (single-level or multi-level, open or minimally invasive approach) 5. No severe cognitive impairment (Mini-Mental State Examination score \> 9) 6. Scheduled to undergo surgery within 6-8 weeks after screening (allowing completion of the 6-week prehabilitation program) Exclusion Criteria: 1. Scheduled to undergo other emergency surgery or day surgery 2. Urgent medical conditions requiring priority management before spinal surgery 3. With spinal disorders other than degenerative diseases (spinal fracture, tumor, metastasis, infection, ankylosing spondylitis, scoliosis with Cobb angle \>40°) 4. With contraindications to prehabilitation exercise (New York Heart Association Class IV heart failure, unstable angina, uncontrolled hypertension \[systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg despite medication\]) 5. With severe functional disability for other disorders or long-term bedridden status unable to perform basic physical activities 6. With allergy or intolerance to nutritional supplements used in the prehabilitation program 7. Participating in another clinical trial involving prehabilitation, perioperative intervention, or spinal surgery within 3 months before screening
Where this trial is running
Beijing, Beijing Municipality and 3 other locations
- Xuanwu hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
- Beijing Friendship Hospital of Capital Medical University — Beijing, China (Recruiting)
- Department of Orthopedics, the Seventh Mecical Center of PLA General Hospital — Beijing, China (Recruiting)
- Peking University First Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Shuaikang Wang, MD
- Email: jackwangDR@163.com
- Phone: 15804084262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.