Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II

NCT07396077 | Recruiting DMC

• 1 other identifier: Xuanwu_PRACTICE-2
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 4

Brief Summary

This multicenter, parallel-group, assessor-blinded randomized controlled trial will enroll 248 adults aged ≥75 years with degenerative lumbar spinal diseases scheduled for elective lumbar fusion surgery, and they will be randomized 1:1 into the intervention and usual care groups. The intervention group will receive a 6-week PHYSIO-Prehab multimodal prehabilitation program, including multicomponent exercise, nutritional intervention, comorbidity optimization, and cognitive prehabilitation with brain protection strategies. The control group will receive standard health education provided via a manual, and both groups will receive consistent perioperative Enhanced Recovery After Surgery care. The primary outcome will be the change in Barthel Index (a tool for assessing independence in activities of daily living) from baseline to 30 days postoperatively; secondary outcomes will include pain scores, disability, patient satisfaction, and the 30-day postoperative Comprehensive Complication Index. The trial will initiate recruitment in April 2026 and conclude in December 2027, aiming to evaluate the feasibility and efficacy of PHYSIO-Prehab and provide high-quality evidence for patient-centered perioperative care pathways in this population.

Conditions

Lumbar Degenerative Disease; Frail Elderly; Enhanced Recovery After Surgery (ERAS) Protocol; Prehabilitation; Spine Degeneration

Keywords

Prehabilitation; ERAS; lumbar fusion; ADL

Outcome Measures

Primary Outcomes (2)

• Change in Barthel ADL Index from baseline to 30 days postoperatively

  Primary efficacy outcome

  Within 30 days after surgery

• 30-day postoperative Comprehensive Complication Index

  The proportion of participants with a Comprehensive Complication Index \> 20

  Within 30 days after surgery

Secondary Outcomes (8)

• 30-day Barthel ADL Index postoperatively

  Within 30 days after surgery

• 30-day postoperative Comprehensive Complication Index

  Within 30 days after surgery

• Length of hospital stay

  Within 30 days after surgery

• NRS for back and leg pain on day 30 after surgery

  Within 30 days after surgery

• North American Spine Society scale of satisfaction on day 30 after surgery

  Within 30 days after surgery

Study Arms (2)

PHYSIO-Prehab group

EXPERIMENTAL

The intervention group will receive a 6-week PHYSIO-Prehab multimodal prehabilitation program care. It includes 3 biweekly supervised group sessions and home-based multicomponent exercise. Additional interventions cover nutritional optimization, comorbidity management (targeting anemia, hypertension, and diabetes), and cognitive prehabilitation with brain protection measures. Both groups will receive consistent perioperative ERAS care implemented by the orthopedic department since January 2019, including multimodal and preemptive analgesia, inspiratory muscle training, minimal intravenous fluid administration, early urinary tube removal, avoidance of mechanical bowel preparation, no prolonged fasting, and antithrombotic prophylaxis

Other: Multimodal physiological reserve optimizing prehabilitation program

Usual care group

ACTIVE COMPARATOR

Participants in the group will receive standard care per the enhanced recovery protocol for lumbar fusion in older adults, including pre-admission health education on smoking/excessive drinking cessation, optimization of severe comorbidities, and general nutritional education.

Other: Usual Care

Interventions

Multimodal physiological reserve optimizing prehabilitation program OTHER

The PHYSIO-Prehab program features targeted multimodality integration, addressing the unmet need for surgery-specific preoperative interventions in elderly lumbar fusion patients. Its innovations lie in three aspects: first, it combines supervised group sessions with home-based exercise, balancing professional guidance and practical feasibility, and adjusts intensity via the Borg 10-point scale to fit individual tolerance. Second, it goes beyond conventional prehabilitation by integrating nutritional optimization, comorbidity management and cognitive prehabilitation, targeting physiological reserve deficits and frailty-related risks. Third, it is tailored to lumbar spinal disease characteristics, optimizing exercise modalities to avoid lumbar burden, which overcomes the limitations of general frailty interventions and enhances relevance to surgical recovery needs.

PHYSIO-Prehab group

Usual Care OTHER

Both groups will receive consistent perioperative ERAS care implemented by the orthopedic department since January 2019, including multimodal and preemptive analgesia, inspiratory muscle training, minimal intravenous fluid administration, early urinary tube removal, avoidance of mechanical bowel preparation, no prolonged fasting, and antithrombotic prophylaxis.

Usual care group

Eligibility Criteria

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

You may qualify if:

• Aged ≥75 years at the time of screening
• Voluntarily sign the informed consent form
• Clinically diagnosed with degenerative lumbar spinal disorders with duration of symptoms \>6 months
• Requiring elective lumbar fusion surgery (single-level or multi-level, open or minimally invasive approach)
• No severe cognitive impairment (Mini-Mental State Examination score \> 9)
• Scheduled to undergo surgery within 6-8 weeks after screening (allowing completion of the 6-week prehabilitation program)

You may not qualify if:

• Scheduled to undergo other emergency surgery or day surgery
• Urgent medical conditions requiring priority management before spinal surgery
• With spinal disorders other than degenerative diseases (spinal fracture, tumor, metastasis, infection, ankylosing spondylitis, scoliosis with Cobb angle \>40°)
• With contraindications to prehabilitation exercise (New York Heart Association Class IV heart failure, unstable angina, uncontrolled hypertension \[systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg despite medication\])
• With severe functional disability for other disorders or long-term bedridden status unable to perform basic physical activities
• With allergy or intolerance to nutritional supplements used in the prehabilitation program
• Participating in another clinical trial involving prehabilitation, perioperative intervention, or spinal surgery within 3 months before screening

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (4)

Xuanwu hospital, Capital Medical University

Beijing, Beijing Municipality, 10053, China

RECRUITING

Beijing Friendship Hospital of Capital Medical University

Beijing, China

RECRUITING

Department of Orthopedics, the Seventh Mecical Center of PLA General Hospital

Beijing, China

RECRUITING

Peking University First Hospital

Beijing, China

RECRUITING

Related Publications (5)

• 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

• Debono B, Wainwright TW, Wang MY, Sigmundsson FG, Yang MMH, Smid-Nanninga H, Bonnal A, Le Huec JC, Fawcett WJ, Ljungqvist O, Lonjon G, de Boer HD. Consensus statement for perioperative care in lumbar spinal fusion: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Spine J. 2021 May;21(5):729-752. doi: 10.1016/j.spinee.2021.01.001. Epub 2021 Jan 12.

  PMID: 33444664 BACKGROUND

• Veronesi F, Borsari V, Martini L, Visani A, Gasbarrini A, Brodano GB, Fini M. The Impact of Frailty on Spine Surgery: Systematic Review on 10 years Clinical Studies. Aging Dis. 2021 Apr 1;12(2):625-645. doi: 10.14336/AD.2020.0904. eCollection 2021 Apr.

  PMID: 33815887 BACKGROUND

• O'Lynnger TM, Zuckerman SL, Morone PJ, Dewan MC, Vasquez-Castellanos RA, Cheng JS. Trends for Spine Surgery for the Elderly: Implications for Access to Healthcare in North America. Neurosurgery. 2015 Oct;77 Suppl 4:S136-41. doi: 10.1227/NEU.0000000000000945.

  PMID: 26378351 BACKGROUND

• Katz JN, Zimmerman ZE, Mass H, Makhni MC. Diagnosis and Management of Lumbar Spinal Stenosis: A Review. JAMA. 2022 May 3;327(17):1688-1699. doi: 10.1001/jama.2022.5921.

  PMID: 35503342 BACKGROUND

Central Study Contacts

Shuaikang Wang, MD

CONTACT

15804084262; jackwangDR@163.com

Shibao Lu, Ph.D., MD

CONTACT

18301680586; 2984335856@163.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: April 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)