Rehabilitation to prevent nearby spine degeneration after lumbar fusion in high-risk older adults
A Randomized Controlled Trial of Multimodal Rehabilitation Versus Standard Care on Adjacent Segment Degeneration in Frail Elderly Patients Undergoing Short-Segment Lumbar Fusion
We will see if a structured multimodal rehab program started 12 weeks after short-segment lumbar fusion helps delay or reduce adjacent segment degeneration in frail people aged 75 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 3 sites (Beijing, Beijing Municipality and 2 other locations) |
| Trial ID | NCT07396051 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized controlled trial enrolling frail patients aged 75 and older undergoing first-time posterior short-segment (1–2 level) lumbar instrumented fusion. Participants are randomized to a supervised multimodal rehabilitation program begun 12 weeks after surgery or to standard postoperative care, with interventions targeting paraspinal muscle endurance, global alignment, bone health, and overall frailty. The rehab program combines progressive resistance and stabilization training, bone-loading and balance exercises, and optimization of nutrition/osteoporosis management under physiotherapist supervision. Outcomes focus on imaging and clinical measures of adjacent segment degeneration and functional status over a two-year follow-up.
Who should consider this trial
Good fit: Ideal candidates are frail adults aged 75 or older scheduled for first-time posterior short-segment (1–2 level) lumbar instrumented fusion who can give informed consent and commit to supervised rehab and two years of follow-up.
Not a fit: Patients with prior lumbar surgery, lumbar disease from tumor/trauma/infection/congenital deformity, or severe comorbidities (for example advanced dementia or severe cardiopulmonary disease) that prevent participation are unlikely to benefit from this rehabilitation program.
Why it matters
Potential benefit: If successful, the program could slow degeneration at levels next to the fusion, reduce pain and disability, and lower the likelihood of needing additional spine surgery.
How similar studies have performed: While components like resistance training and bone-loading exercises have shown benefit for muscle strength and bone density in older adults, a targeted multimodal program specifically designed to prevent adjacent segment degeneration after fusion is novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 75 years. * Classified as "frail" according to the Fried frailty phenotype. * Scheduled for first-time, posterior short-segment (1-2 levels) lumbar instrumented fusion surgery. * Willing and able to provide written informed consent and complete the 2-year follow-up. Exclusion Criteria: * History of previous lumbar spine surgery. * Lumbar pathology due to tumor, trauma, infection, or congenital deformity. * Comorbidities with a severe impact on prognosis or ability to participate in rehabilitation (e.g., severe cardiopulmonary disease, advanced dementia).
Where this trial is running
Beijing, Beijing Municipality and 2 other locations
- Beijing Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Peking University First Hospital, Beijing, Beijing 10034 — Beijing, Beijing Municipality, China (Recruiting)
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Lu Shibao, MD.
- Email: 1831327488@qq.com
- Phone: 18310031517
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.