NCT07396077 Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II
| NCT ID | NCT07396077 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Spine Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 248 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 248 participants in total. It began in 2026-04-15 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07396077 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Spine Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07396077 currently recruiting?
Yes, NCT07396077 is actively recruiting participants. Contact the research team at jackwangDR@163.com for enrollment information.
Where is the NCT07396077 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Beijing, China.
Who is sponsoring the NCT07396077 clinical trial?
NCT07396077 is sponsored by Xuanwu Hospital, Beijing. The trial plans to enroll 248 participants.