Actively Recruiting

Phase Not Applicable
Age: 75Years +
All Genders
ID07396077

Multimodal Physiological Reserve Optimizing Prehabilitation Program (PHYSIO-Prehab) in Elderly Adults Undergoing Lumbar Fusion Surgery

Led by Xuanwu Hospital, Beijing · Updated on 2026-04-28

248

Participants Needed

4

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a multimodal prehabilitation program called PHYSIO-Prehab for adults aged 75 years and older who have degenerative lumbar spinal diseases and are scheduled for elective lumbar fusion surgery. This randomized controlled trial aims to assess whether the PHYSIO-Prehab program can improve recovery after surgery, including independence in daily activities and reduction of complications. The study addresses the lack of targeted preoperative care for older adults facing higher surgical risks due to frailty and multiple health conditions. Participants will be randomly assigned to either the intervention group receiving the 6-week PHYSIO-Prehab program or the control group receiving usual care with standard health education. The PHYSIO-Prehab program includes supervised group sessions twice weekly, home-based exercises such as resistance, balance, aerobic, and stretching training, nutritional optimization, management of anemia, hypertension, and diabetes, and cognitive prehabilitation with brain protection strategies. Both groups will receive standardized Enhanced Recovery After Surgery care during the perioperative period. During the study, participants will be assessed for changes in their ability to perform daily activities using the Barthel Index, pain levels, disability, patient satisfaction, and postoperative complications within 30 days after surgery. The study will also monitor hospital stay length, discharge status, and unplanned readmissions. The trial will recruit from April 2026 to December 2027, aiming to provide strong evidence for improving perioperative care in elderly lumbar spine surgery patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 75Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 75 years or older at the time of screening
  • Voluntarily sign the informed consent form
  • Clinically diagnosed with degenerative lumbar spinal disorders lasting more than 6 months
  • Scheduled for elective lumbar fusion surgery (single-level or multi-level, open or minimally invasive)
  • No severe cognitive impairment (Mini-Mental State Examination score greater than 9)
  • Surgery planned within 6 to 8 weeks after screening to complete the 6-week prehabilitation program
Not Eligible

You will not qualify if you...

  • Scheduled for emergency surgery or day surgery
  • Urgent medical conditions requiring priority treatment before spinal surgery
  • Spinal disorders other than degenerative diseases (such as fracture, tumor, infection, ankylosing spondylitis, scoliosis with Cobb angle greater than 40 degrees)
  • Contraindications to prehabilitation exercise (New York Heart Association Class IV heart failure, unstable angina, uncontrolled hypertension despite medication)
  • Severe functional disability or long-term bedridden status preventing basic physical activities
  • Allergy or intolerance to nutritional supplements used in the prehabilitation program
  • Participation in another clinical trial involving prehabilitation, perioperative intervention, or spinal surgery within 3 months before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 6 weeks

Participants complete a 6-week multimodal prehabilitation program consisting of supervised group sessions, home-based exercises, nutritional optimization, comorbidity management, and cognitive prehabilitation before surgery.

3 supervised group sessions plus home-based exercises 3 times per week

Surgery and Immediate Post-operative Care

Duration - Up to hospital discharge

Participants undergo elective lumbar fusion surgery followed by standardized perioperative enhanced recovery care to reduce complications and support recovery.

Hospital stay with daily clinical care visits

Post-operative Follow-up

Duration - 30 days postoperatively

Participants are monitored for recovery, functional independence, pain, and complications up to 30 days after surgery.

1 visit at 30 days post-surgery

Trial Site Locations

Total: 4 locations

1

Xuanwu hospital, Capital Medical University

Beijing, Beijing Municipality, China, 10053

Actively Recruiting

2

Beijing Friendship Hospital of Capital Medical University

Beijing, China

Actively Recruiting

3

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

Beijing, China

Actively Recruiting

4

Peking University First Hospital

Beijing, China

Actively Recruiting

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Research Team

S

Shuaikang Wang, MD

S

Shibao Lu, Ph.D., MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Consensus statement for perioperative care in lumbar spinal fusion: Enhanced Recovery After Surgery (ERAS®) Society recommendations.

Bertrand Debono, Thomas W Wainwright, Michael Y Wang...

https://pubmed.ncbi.nlm.nih.gov/33444664