RecruitingNot ApplicableNCT07396051

Rehabilitation Exercise Against Complications in High-risk Elderly After Lumbar Fusion(REACH)

A Randomized Controlled Trial of Multimodal Rehabilitation Versus Standard Care on Adjacent Segment Degeneration in Frail Elderly Patients Undergoing Short-Segment Lumbar Fusion


Sponsor

Xuanwu Hospital, Beijing

Enrollment

212 participants

Start Date

Jan 25, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, randomized controlled trial aimed at evaluating whether a structured multimodal rehabilitation program can delay or reduce the occurrence of adjacent segment degeneration (ASDeg) in frail elderly patients after short-segment lumbar fusion surgery.


Eligibility

Min Age: 75 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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).

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Interventions

BEHAVIORALPostoperative Multimodal Rehabilitation Program

All subjects independently completed the training program postoperatively. During follow-up, two physical therapists were responsible for arranging and designing the training sessions for the next phase. The therapists possessed equivalent levels of clinical experience. Based on clinical experience, scientific knowledge, and personal conviction, the therapists were confident that they provided the best treatment plan for the patients. To ensure consistency in treatment implementation throughout the study, fidelity checks were conducted at the end of each treatment session and course, in accordance with the cognitive-behavioral therapy and exercise training implementation manual. After enrollment, patients did not receive other treatments (such as physical therapy or nerve block), and the use of major pharmacological agents was prohibited, except for the allowance of mild analgesics and non-steroidal anti-inflammatory drugs.


Locations(3)

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital, Beijing, Beijing 10034

Beijing, Beijing Municipality, China

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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NCT07396051


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