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

NCT07396051 | Recruiting

• 1 other identifier: Xuanwu-REACH
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Adjacent Segment Degeneration; Multimodal Rehabilitation; Lumber Fusion

Outcome Measures

Primary Outcomes (1)

• Time to Adjacent Segment Degeneration (ASDeg)

  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 Outcomes (4)

• Comprehensive Complication Index

  Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.

• Oswestry disability index

  Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.

• Leg Pain Visual Analog Scale (VAS) Score

  Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.

• Japanese Orthopaedic Association (JOA) Score for Low Back Pain

  Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.

Study Arms (2)

Routine Care Group

NO INTERVENTION

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.

Multimodal Rehabilitation Group

EXPERIMENTAL

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

Interventions

Postoperative Multimodal Rehabilitation Program BEHAVIORAL

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.

Multimodal Rehabilitation Group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (3)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 10053, China

RECRUITING

Peking University First Hospital, Beijing, Beijing 10034

Beijing, Beijing Municipality, 10053, China

RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 10053, China

RECRUITING

Related Publications (8)

• Gillis C, Ljungqvist O, Carli F. Prehabilitation, enhanced recovery after surgery, or both? A narrative review. Br J Anaesth. 2022 Mar;128(3):434-448. doi: 10.1016/j.bja.2021.12.007. Epub 2022 Jan 7.

  PMID: 35012741 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Parker SG, McCue P, Phelps K, McCleod A, Arora S, Nockels K, Kennedy S, Roberts H, Conroy S. What is Comprehensive Geriatric Assessment (CGA)? An umbrella review. Age Ageing. 2018 Jan 1;47(1):149-155. doi: 10.1093/ageing/afx166.

  PMID: 29206906 BACKGROUND

• Whittle AK, Kalsi T, Babic-Illman G, Wang Y, Fields P, Ross PJ, Maisey NR, Hughes S, Kwan W, Harari D. A comprehensive geriatric assessment screening questionnaire (CGA-GOLD) for older people undergoing treatment for cancer. Eur J Cancer Care (Engl). 2017 Sep;26(5). doi: 10.1111/ecc.12509. Epub 2016 May 1.

  PMID: 27132979 BACKGROUND

• Karsy M, Chan AK, Mummaneni PV, Virk MS, Bydon M, Glassman SD, Foley KT, Potts EA, Shaffrey CI, Shaffrey ME, Coric D, Asher AL, Knightly JJ, Park P, Fu KM, Slotkin JR, Haid RW, Wang M, Bisson EF. Outcomes and Complications With Age in Spondylolisthesis: An Evaluation of the Elderly From the Quality Outcomes Database. Spine (Phila Pa 1976). 2020 Jul 15;45(14):1000-1008. doi: 10.1097/BRS.0000000000003441.

  PMID: 32097272 BACKGROUND

• Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.

  PMID: 30074971 BACKGROUND

• Rivier C, Shen GH. In the rat, endogenous nitric oxide modulates the response of the hypothalamic-pituitary-adrenal axis to interleukin-1 beta, vasopressin, and oxytocin. J Neurosci. 1994 Apr;14(4):1985-93. doi: 10.1523/JNEUROSCI.14-04-01985.1994.

  PMID: 8158253 BACKGROUND

• Kassebaum DG, Judkins MP, Griswold HE. Stress electrocardiography in the evaluation of surgical revascularization of the heart. Circulation. 1969 Sep;40(3):297-313. doi: 10.1161/01.cir.40.3.297. No abstract available.

  PMID: 5810888 BACKGROUND

Central Study Contacts

Lu Shibao, MD.

CONTACT

18310031517; 1831327488@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: January 25, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)