BridgeMD
New treatment option for Spine Degeneration
Official title Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II
ClinicalTrials.gov ID: NCT07396077
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older
You may be able to join 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)
You likely can't join 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...
- With contraindications to prehabilitation exercise (New York Heart Association Class IV heart failure, unstable angina, uncontrolled hypertension...
- 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
See the full eligibility criteria
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Beijing, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.