NCT07465159 Multimodal Prehabilitation of Frail Patients Undergoing Elective Knee or Hip Replacement
| NCT ID | NCT07465159 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Iceland |
| Condition | Frailty Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-03-20 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-03-20 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Frailty is a geriatric syndrome of reduced physiologic reserve that increases surgical risk and is common among older adults undergoing hip or knee replacement. While prehabilitation has shown promise in enhancing outcomes, evidence from randomized controlled trials (RCTs) in frail orthopedic patients is limited. Objective: This study aims to evaluate the feasibility and preliminary data on the effectiveness of a multimodal prehabilitation program for frail patients undergoing elective hip or knee arthroplasty. Methods: A pilot RCT will be conducted at Landspítali-University Hospital. Patients ≥70 years scheduled for surgery with ≥2 months waiting time will be screened for frailty using PRISMA-7, the Clock Drawing Test, and Timed Up \& Go. Patients screening positive for any of the three screening tools will be randomized to multimodal prehabilitation or standard of care. The intervention includes comprehensive geriatric assessment, medication review, tailored physiotherapy using the Otago Exercise Programme, and nutritional counseling if at risk of malnutrition. We will conduct an external pilot for feasibility measures (overall enrollment, recruitment, retention, adherence). Secondary outcomes include physical performance, postoperative complications, patient-reported health status (WOMAC scale) and quality of life (EQ-5D-5L ), length of primary hospital stay, discharge location, falls postoperatively, 180-day readmission and 180-day mortality. Significance: This trial may aid in the design of larger RCT study and provide a signal of the role of multimodal prehabilitation on outcomes, including quality of life and health status among frail arthroplasty patients.
Eligibility Criteria
Inclusion Criteria: * Patients aged 70 years or older assigned to undergo hip/knee replacement at Landspítali University Hospital. * Inclusion will be offered to patients who have previously presented at the outpatient orthopedic department and been scheduled for an elective (with a waiting period ≥2 months before surgery) hip/knee replacement. * Patients who are willing to participate and sign informed consent and are willing to be randomized to the control or intervention arm. Exclusion Criteria: * Patients who screen negative for all frailty tools will be excluded from the study. * Patients who are already in active physiotherapy, meeting with a physiotherapist \>1 every month, will also be excluded. * In addition, those who do not undergo planned surgery, are undergoing redo hip/knee prosthesis replacement will be excluded
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07465159 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Frailty Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07465159 currently recruiting?
Yes, NCT07465159 is actively recruiting participants. Contact the research team at mingi@hi.is for enrollment information.
Where is the NCT07465159 trial being conducted?
This trial is being conducted at Reykjavik, Iceland.
Who is sponsoring the NCT07465159 clinical trial?
NCT07465159 is sponsored by University of Iceland. The trial plans to enroll 50 participants.