Actively Recruiting
Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II
Led by Xuanwu Hospital, Beijing · Updated on 2026-04-28
248
Participants Needed
4
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 75 years or older at the time of screening
- Voluntarily signed informed consent
- Diagnosed with degenerative lumbar spinal disorders lasting more than 6 months
- Scheduled for elective lumbar fusion surgery (single or multi-level, open or minimally invasive)
- No severe cognitive impairment (Mini-Mental State Examination score above 9)
- Surgery planned within 6 to 8 weeks after screening to complete the 6-week prehabilitation program
You will not qualify if you...
- Scheduled for other emergency or day surgery
- Urgent medical conditions needing priority treatment before spinal surgery
- Have spinal disorders other than degenerative diseases (such as fractures, tumors, infections, ankylosing spondylitis, or scoliosis with Cobb angle over 40 degrees)
- Contraindications to exercise including severe heart failure, unstable angina, or uncontrolled high blood pressure
- Severe disability or long-term bedridden status preventing basic physical activity
- Allergy or intolerance to nutritional supplements used in the program
- Participation in another clinical trial involving prehabilitation, perioperative intervention, or spinal surgery within 3 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Xuanwu hospital, Capital Medical University
Beijing, Beijing Municipality, China, 10053
Actively Recruiting
2
Beijing Friendship Hospital of Capital Medical University
Beijing, China
Actively Recruiting
3
Department of Orthopedics, the Seventh Mecical Center of PLA General Hospital
Beijing, China
Actively Recruiting
4
Peking University First Hospital
Beijing, China
Actively Recruiting
Research Team
S
Shuaikang Wang, MD
CONTACT
S
Shibao Lu, Ph.D., MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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