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

February 11, 2026 updated by: Xuanwu Hospital, Beijing

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Rationale and Scientific Background Adjacent segment degeneration (ASDeg) represents a major determinant of long-term clinical success after lumbar fusion. In frail older adults (≥75 years, Fried phenotype), the risk is theorized to be amplified due to age-related sarcopenia, osteopenia, diminished healing capacity, and compensatory biomechanical overload. While Enhanced Recovery After Surgery (ERAS) protocols address acute perioperative stress, they do not provide a targeted, long-term strategy to modify the underlying biological and biomechanical progression toward ASD. This trial is grounded on the hypothesis that a structured, multimodal rehabilitation program, initiated after the initial bone-soft tissue healing phase (12 weeks), can enhance paraspinal muscular endurance, improve global sagittal alignment, increase bone density, and mitigate systemic frailty. This multisystem approach aims to decelerate the degenerative cascade at adjacent segments compared to standard care alone.

  2. Intervention Design and Theoretical Framework Timing Rationale: The intervention commencement at 12 weeks postoperatively is deliberately chosen to avoid interference with initial osseous fusion and wound healing, while capitalizing on the phase of maximal functional plasticity and patient engagement in recovery.

    Multimodal Components: The program integrates three evidence-based components supervised by a physiotherapist:

    Progressive Resistance & Stabilization Training: Targets deep spinal stabilizers and global movers to restore functional strength and reduce segmental strain.

    Neuromotor & Balance Re-education: Addresses age-related proprioceptive decline to improve movement efficiency and reduce fall risk.

    Pain Neuroscience Education & Activity Pacing: Aims to modify maladaptive pain behaviors and fear-avoidance beliefs, promoting sustained engagement.

    Adherence Strategy & Measurement: Adherence is not merely recorded but is actively managed as a modifiable process variable. The weekly Likert-scale tracking (via phone/app) serves as both a measurement tool and a behavioral prompt. The >70% adherence threshold (cumulative score >135/196) is based on prior rehabilitation efficacy studies, defining a minimum "dose" for expected biological effect. Illustrated manuals and periodic in-person sessions ensure correct technique and gradual progression, addressing a key limitation of unsupervised home exercise.

  3. Outcome Selection and Measurement Rationale Primary Outcome Justification: Time to ASD (in days) was selected over a simple binary incidence rate because it is a time-to-event measure that captures both the occurrence and the timing of degeneration, providing greater statistical power and clinical relevance regarding the delay of disease.

    Secondary Outcome Triangulation: The combination of patient-reported outcomes (VAS, ODI), physician-assessed function (JOA), objective physiological measures (BMD, Fried score), and radiographic biomechanics (PI-LL, SVA) allows for a comprehensive evaluation of treatment effect across the domains of symptoms, function, biology, and structure. This aligns with the multifactorial nature of both frailty and ASD.

  4. Methodological Rigor and Design Considerations Randomization & Blinding: 1:1 block randomization will be performed by an independent statistician using sealed envelopes. While participants and treating therapists cannot be blinded to group assignment, all outcome assessors (radiologists evaluating ASD, researchers collecting PROs) will remain blinded to minimize assessment bias.

    Handling Expected Challenges in a Frail Population: The protocol includes explicit strategies for managing common issues: 1) Flexible follow-up modes (clinic, phone, app) to reduce dropout; 2) LOCF imputation for missing data specified a priori in the statistical plan; and 3) Adverse event monitoring specifically for rehabilitation-related musculoskeletal complaints.

    Sample Size Consideration: The 20% inflation for attrition is conservative but justified for this older, frail population over a 2-year follow-up. Sensitivity analyses (e.g., per-protocol, complier-average causal effect models) are pre-planned to assess the robustness of findings to deviations from the protocol and variable adherence.

  5. Anticipated Impact and Mechanistic Exploration This trial is designed to establish not only whether the intervention works (efficacy) but also to generate hypotheses on how it works. By correlating changes in muscular performance (via functional tests), frailty status, and sagittal alignment with the primary ASD outcome, the study aims to explore potential mediators of treatment effect. The findings are expected to inform the development of a standardized, reproducible rehabilitation protocol tailored to the high-risk frail elderly spine surgery population.

Study Type

Interventional

Enrollment (Estimated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 10053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing Municipality, China, 10053
        • Recruiting
        • Beijing Friendship Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 10053
        • Recruiting
        • Peking University First Hospital, Beijing, Beijing 10034
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine Care Group
All patients in this group undergo standard Enhanced Recovery After Surgery (ERAS) protocols tailored for frail individuals, which encompass optimization of nutrition, pain management, early mobilization, and other evidence-based perioperative measures.
Experimental: Multimodal Rehabilitation Group
This group receives a supervised, structured, and progressive multimodal rehabilitation program in addition to the standard perioperative Enhanced Recovery After Surgery (ERAS) care and initial home exercise guidance.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Adjacent Segment Degeneration (ASDeg)
Time Frame: 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.
From surgery date up to 2 years postoperatively (730 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive Complication Index
Time Frame: Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
The Comprehensive Complication Index (CCI) is based on the complication grading by the Clavien-Dindo Classification and captures every complication that occurred after an intervention. Postoperative complications were recorded to 90-day after surgery (definitions provided in supplementary table 1) and scored by severity using the Clavien-Dindo classification. The CCI was derived from these scores using the CCI calculator available online (http://www.assessurgery.com). Previous studies have validated the CCI as a measure of postoperative morbidity, suggesting that it offers a more comprehensive and sensitive endpoint for surgical research compared to traditional morbidity measures, such as the overall rate of complications or the rate of severe complications.
Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
Oswestry disability index
Time Frame: Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
Oswestry disability index (0 - 100 points, a higher total score reflects higher disability) for lumbar surgery.
Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
Leg Pain Visual Analog Scale (VAS) Score
Time Frame: Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
Patient-reported intensity of leg pain (radicular pain) measured on Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "worst imaginable pain".
Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
Japanese Orthopaedic Association (JOA) Score for Low Back Pain
Time Frame: Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.
Clinician-assessed lumbar spine function measured by the Japanese Orthopaedic Association (JOA) score. Higher scores indicate better function.
Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 25, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Xuanwu-REACH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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