Pre-surgery preparation program for older adults having lumbar fusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.