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

Condition(s) studied

Investigational drug(s) / intervention(s)

Postoperative 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.

Study 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

Primary outcome measure(s)

• Time to Adjacent Segment Degeneration (ASDeg) — From surgery date up to 2 years postoperatively (730 days).
  The number of days from the surgery date to the radiographic diagnosis of ASDeg. For participants who do not develop ASD during the study, the data will be censored at 730 days (2 years postoperatively). This measure is used to compare the intervention and control groups.

Trial sites (3)

More Xuanwu Hospital, Beijing trials in China

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