Pre-surgery conditioning and optimization for hip or knee replacement
Preoperative Optimization Before Total Hip or Knee Replacement Surgery - a Controlled, Randomized, Single-blind Study
NA · Medical University Innsbruck · NCT07394582
This will try a tailored pre-surgery program for adults with higher surgical risk (ASA ≥3) who are waiting at least eight weeks for elective hip or knee replacement to see if it improves recovery and reduces complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Medical University Innsbruck (other) |
| Locations | 1 site (Innsbruck, Tyrol) |
| Trial ID | NCT07394582 on ClinicalTrials.gov |
What this trial studies
The PrOpE protocol randomizes 180 adults scheduled for elective total hip or knee replacement who are classified ASA ≥3 to either usual care or an individualized preoperative optimization (prehabilitation) program. The multi-week intervention can include tailored physical training, nutritional support, medication review, and stress or anxiety management delivered before surgery. The main aim is to test the feasibility of delivering this comprehensive program and to explore effects on postoperative recovery, complications, function, and quality of life. The single-center study enrolls adults 18–99 with at least an eight-week wait to surgery and capacity to consent at the Medical University Innsbruck.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–99 with ASA physical status ≥3 who are scheduled for elective total hip or knee replacement with at least eight weeks before surgery and who can give informed consent.
Not a fit: Patients who are pregnant or breastfeeding, have contraindications to physical training, severe cognitive impairment, very recent major trauma or blood loss, are enrolled in another interventional study, or need surgery sooner than eight weeks are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the program could help patients recover faster, have fewer complications, and return to normal activities sooner after hip or knee replacement.
How similar studies have performed: Previous prehabilitation programs for joint replacement have shown modest improvements in fitness and some recovery measures but results are mixed, so this comprehensive program builds on limited and variable evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status classification ≥ 3 * Age between 18 and 99 years * All sexes * Elective total hip or knee replacement with a waiting period of ≥ 8 weeks between surgical indication and surgery * Ability to understand the nature, content, and procedures of the study and to provide written informed consent * Written informed consent obtained prior to any study-related procedure Exclusion Criteria: * Pregnancy or active breastfeeding * Severe trauma or major blood loss within 14 days prior to enrollment * Participation in another pharmacological or interventional clinical study * Contraindications to physical training * Pre-existing diagnosis of moderate to severe dementia
Where this trial is running
Innsbruck, Tyrol
- Medical University Innsbruck — Innsbruck, Tyrol, Austria (RECRUITING)
Study contacts
- Principal investigator: Barbara Sinner, MD, MBA — Medical University Innsbruck
- Study coordinator: Helmut Raab, MD
- Email: helmut.raab@tirol-kliniken.at
- Phone: +435050480833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prehabilitation, Preoperative Care, Preoperative Optimization, orthopedic surgery