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

RecruitingNAAges 75 Years - anyAllXuanwu Hospital, Beijing
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In plain words

What the trial is, and whether it could suit you

This multicenter, parallel-group, assessor-blinded randomized controlled trial will enroll 248 adults aged โ‰ฅ75 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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Aged โ‰ฅ75 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 \>40ยฐ) 4. With contraindications to prehabilitation exercise (New York Heart Association Class IV heart failure, unstable angina, uncontrolled hypertension \[systolic BP โ‰ฅ180 mmHg or diastolic BP โ‰ฅ110 mmHg despite medication\]) 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
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What it tests

  • Multimodal physiological reserve optimizing prehabilitation program
  • Usual Care
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Where

4 sites
Xuanwu hospital, Capital Medical University
Beijing, China
Beijing Friendship Hospital of Capital Medical University
Beijing, China
Department of Orthopedics, the Seventh Mecical Center of PLA General Hospital
Beijing, China
Peking University First Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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