Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery (PRACTICE)

September 18, 2025 updated by: Xuanwu Hospital, Beijing

Prehabilitation Combined With Enhanced Recovery After Surgery (PREERAS) in the Chinese Elderly With Spine Surgery

With the extended life expectancy of the Chinese population and improvements in surgery and anesthesia techniques, the number of aged patients undergoing surgery has been increasing annually. However, safety, effectiveness, and quality of life of aged patients undergoing surgery are facing major challenges. This prospective, multi-center, randomized, controlled study aims to construct a prehabilitation combined with enhanced recovery after surgery program which includes pre-operative risk assessment and targeted intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

According to the United Nations 2022 Revision of World Population Prospects, the proportion of people over 65 years of age is expected to increase from approximately 9.7% in 2022 to 16.4% in 2050. The burden of spine disorders has increased substantially with the unprecedented aging population and the increase in life expectancy. Recent studies using multicenter data have showed that the increase in spinal fusions for spinal degenerative diseases was highest among patients over 75 years. Despite improved quality-adjusted life years and symptomatic benefits with spinal fusion surgery, there is an observed excess of adverse postoperative outcomes in older patients (aged 75 years and older) compared with younger patients. Enhanced Recovery After Surgery (ERAS) involves multidisciplinary perioperative measures to reduce surgical stress responses and improve perioperative outcomes and postoperative recovery. However, ERAS does not include preoperative comprehensive interventions to address or optimize the comorbidities, malnutrition, decreased functional capacity that are commonly present in older patients. In addition to the comorbid risk factors that older patients share with younger ones, older patients may also have malnutrition and cognitive or functional impairment. In older patients, the accumulation of geriatric frailty and various geriatric syndromes leads to decreased physiological reserves, resulting in a challenging recovery process after spine surgery. A possible way to overcome this variability and therefore to identify the patients at risk of adverse events (AEs) is to use specific tools developed by geriatricians and included in the so-called Comprehensive Geriatric Assessment (CGA).

CGA is a multi-dimensional diagnostic process designed to evaluate an elderly patient's medical, psychosocial, functional, and environmental resources and links them with an overall plan of treatment and follow-up. Guidelines and recommendations have addressed the importance of combined geriatric assessment and operational risks as an alternative to traditional preoperative assessment in elderly patients. The value of CGA in predicting long-term quality-of-life and functional decline has been demonstrated in previous studies on cancer surgery and hip fracture surgery; however, few studies on spine surgery included CGA in their analyses. Although some items in CGA, such as frailty and depression, have been shown to be associated with postoperative complications after spinal surgery, few studies have performed a complete evaluation of CGA in older patients. The reluctance of site leads and participants to use the comprehensive tool may reflect the volume of information it included, which may have made it difficult for clinicians to identify and use relevant sections. Most older people who have spinal disorders are frail, have comorbidities, and show a functional deterioration, which adversely affects quality of life and delays postoperative rehabilitation. Prehabilitation programs aim to strengthen patients physically and mentally before surgery by addressing modifiable risk factors during the preoperative period while they are waiting for surgery thereby filling this existing gap. Emerging evidence suggests a benefit of prehabilitation before major abdominal and cardiothoracic surgery. However, high-level evidence supporting the integration of CGA-based prehabilitation into ERAS program is still limited, particularly within the context of spine surgery.

The overall aim of this work is to examine the effect of multimodal prehabilitation combined with perioperative ERAS care (PREERAS) compared to only-ERAS in older patients (aged 75 years and older) scheduled for spinal fusion surgery. The study hypothesizes that the PRE-ERAS program will be more effective than only-ERAS care in improving postoperative clinical outcomes and patients-reported outcomes (PRO).

Study design and setting This study is a prospective, multicenter, parallel, randomized, controlled study. This study will be carried out in three tertiary teaching hospitals, including Xuanwu Hospital, Peking University First Hospital, and Beijing Friendship Hospital. The patients of control group will receive the established perioperative ERAS care. Pre-admission intervention include education on smoking and excessive drinking cessation, available counseling services, optimization of chronic disease, and nutritional assessment and support (only through nutritional education). Participants randomized to the intervention group will receive PREERAS management. PREERAS mainly consists of geriatric assessment, Vivifrail multicomponent exercise, nutritional intervention, cognitive prehabilitation and brain protection. The study will start in April 2024. The recruitment period will be 20 months, with a follow-up of 90 days. The results of the study will be expected in December 2025.

Primary outcomes: The primary outcome is the Comprehensive Complication Index (CCI; scores range from 0 to 100, with a score of 100 being death as a result of complications) which integrates all complications with their respective severities on a continuous scale ranging from 0 (no burden due to complications) to 100 (death as a result of complications). The 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.

Secondary outcomes: Pain levels and pain-related function and activity limitation will be measured by visual analogue scale (VAS) and Oswestry/Neck disability index (ODI/NDI). Health- related quality of life will be evaluated by EuroQol Five Dimensions Questionnaire (EQ-5D, 0 = worst health and 100 = best health). Physical function will be assessed using 6 m walking speed and hand grip strength. Patient satisfaction will be measured using the North American Spine Society (NASS) satisfaction scale, measured on a scale of 1-4, with 1 indicating most satisfied and 4 indicating least satisfied. Answers on the satisfaction scale are as follows: The treatment met my expectations (score 1); I don't not improve as much as I had hoped, but I would undergo the same treatment for the same outcome (score 2); I don't improve as much as I had hoped, and I would not undergo the same treatment for the same outcome (score 3); I am the same or worse than before treatment (score 4). Data regarding primary and total length of hospital stay, non-home discharge, readmissions, and unplanned readmission within 90 days after surgery will be followed up. The discharge criteria for all patients were as follows: (1) preoperative symptoms are entirely or mainly relieved, or treatment has met the patient's expectations; (2) patients have no surgery-related complications, or the postoperative complications have been controlled, and (3) no further treatment is required.

Study Type

Interventional

Enrollment (Actual)

164

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 Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 10034
        • Peking University First Hospital
      • Beijing, Beijing Municipality, China, 10050
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, Beijing Municipality, China, 10053
        • Xuanwu Hospital, Capital Medical University

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:

  1. patients who voluntarily sign the informed consent form; (2) elective spinal fusion surgery for degenerative spinal disorders; (3) no severe cognitive impairment (MoCA score ≥ 8).

    Exclusion Criteria:

    Patients (1) are scheduled to undergo emergency or day surgery,

  2. have urgent condition that needs to be managed before the surgery,
  3. are unable to cooperate with preoperative assessment,
  4. have spinal fractures, metastasis, and spinal infections,
  5. unable to understand or participate safely in intervention program,
  6. participate in another study that may affect the study.

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
Experimental: PREERAS group

Pre-operative risk assessment combined with targeted intervention During the planning phase of the study, we assembled a multidisciplinary team consisting of geriatrician, spine surgeons, nurses, rehabilitation specialists, anesthesiologists, neurologists, nutritionist, and social workers. Then, the multimodal prehabilitation combined with perioperative ERAS care (PREERAS) programme was conducted based on previous studies and surgical guideline.

Participants randomised to the intervention group will receive PREERAS management. PREERAS mainly consists of geriatric assessment, Vivifrail multicomponent exercise, nutritional intervention, cognitive prehabilitation and brain protection.
Combination product: Multimodal prehabilitation combined with perioperative ERAS care（PREERAS）
Pre-admission risk assessment and targeted intervention provided by multidisciplinary team
No Intervention: Control group
The control group will receive standard of enhanced recovery after surgery (ERAS) care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive Complication Index
Time Frame: up to 90 days after surgery
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.
up to 90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck/Oswestry disability index
Time Frame: up to 90 days after surgery
Oswestry disability index (0 - 100 points, a higher total score reflects higher disability) for lumbar surgery and Neck disability index ( 0 - 100 points, a higher total score reflects higher disability] for cervical surgery).
up to 90 days after surgery
EuroQol Five Dimensions Questionnaire (EQ-5D)
Time Frame: up to 90 days after surgery
Health- related quality of life will be evaluated by EuroQol Five Dimensions Questionnaire (EQ-5D, 0 = worst health and 100 = best health).
up to 90 days after surgery
6 m walking speed
Time Frame: up to 90 days after surgery
Time in seconds to walk 6 m at usual pace expressed as m/s
up to 90 days after surgery
North American Spine Society scores
Time Frame: up to 90 days after surgery
Patient satisfaction will be measured using the North American Spine Society (NASS) satisfaction scale, measured on a scale of 1-4, with 1 indicating most satisfied and 4 indicating least satisfied. Answers on the satisfaction scale are as follows: The treatment met my expectations (score 1); I don't not improve as much as I had hoped, but I would undergo the same treatment for the same outcome (score 2); I don't improve as much as I had hoped, and I would not undergo the same treatment for the same outcome (score 3); I am the same or worse than before treatment (score 4).
up to 90 days after surgery
Primary and total length of hospital stay
Time Frame: up to 90 days after surgery
The discharge criteria for all patients are as follows: (1) preoperative symptoms are entirely or mainly relieved, or treatment has met the patient's expectations; (2) patients have no surgery-related complications, or the postoperative complications have been controlled, and (3) no further treatment is required.
up to 90 days after surgery
Rates of non-home discharge
Time Frame: up to 90 days after surgery
The non-home discharge includes inpatient rehabilitation, complex continuing care (CCC), long term care (LTC), and transferred to another inpatient setting.
up to 90 days after surgery
Rates of unplanned readmission
Time Frame: up to 90 days after surgery
90-days unplanned readmission for complications or pain
up to 90 days after surgery
Hand grip strength
Time Frame: up to 90 days after surgery
Grip strength will be measured in both hands. The patients sit in a comfortable position, with their elbows extended, and squeezed the dynamometer with maximum strength. The grip strength will be measured twice for both hands, with a short break in between. The best performance, regardless of hand dominance, will be recorded.
up to 90 days after surgery

Collaborators and Investigators

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

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Study Chair: Shibao Lu, Xuanwu Hospital, Beijing
  • Study Director: Shuaikang Wang, Capital Medical University
  • Principal Investigator: Chun-De Li, Peking University First Hospital
  • Principal Investigator: Yong Yang, Beijing Friendship Hospital

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 (Actual)

April 15, 2024

Primary Completion (Actual)

September 10, 2025

Study Completion (Actual)

September 10, 2025

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Actual)

November 20, 2023

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lushibao

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

product manufactured in and exported from the U.S.

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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