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.
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.
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
Parallel
Multimodal Prehabilitation
Other interventionThe intervention will begin ≥2 months before planned surgery and consists of a multimodal prehabilitation program. Participants will undergo geriatric assessment with frailty evaluation, medication review, and optimization of comorbidities as needed. Patients at risk of malnutrition will receive nutritional assessment, counseling, and supplementation when indicated. All participants will receive individualized physiotherapy based on the Otago Exercise Programme, including strength, balance, and walking exercises. Patients will attend an initial physiotherapy session with follow-up visits and will be encouraged to perform exercises at home multiple times per week at moderate intensity.
Recruitment rate
Out of all the patients screened the recruitment will be defined the proportion of patients who were randomized
Retention rate
Out of all the patients randomized, the proportion of patients who complete follow-up
Overall enrollment yield
Proportion of all patients invited for frailty screening (≥70 years and scheduled for arthroplasty) who are ultimately randomised into the trial.
Exercise adherence
Adherence to exercise prehabilitation, defined as completing ≥80% of the prescribed sessions or tasks.
- Preoperative optimization
If the assessment by the geriatrician lead to any changes to prescribed medications, new diagnoses or if evaluation on current diagnosis/treatment occurred among the patient in the intervention group. These will be noted.
Change in health status (joint pain and function)
Health status assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a 24-item self-administered questionnaire evaluating pain, stiffness, and physical function in patients with osteoarthritis.
Change in quality of life
Quality of life assessed using the EuroQol 5-Dimension 3-Level questionnaire (EQ-5D-5L). The EQ-5D-5L includes five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
Nutritional adherence
Adherence to nutritional guidance assessed using a patient-completed questionnaire administered monthly during the prehabilitation period. Participants will answer the following question: "During the past month, how often did you follow the nutritional recommendations provided to you?" Responses will be recorded on a 5-point Likert scale: 1. Never (0 days per week) 2. Rarely (1-2 days per week) 3. Sometimes (3-4 days per week) 4. Often (5-6 days per week) 5. Always (7 days per week) An average score ≥4.0 will be considered adherent.
Length of hospital stay
Length of the primary hospital stay after surgery, measured in days. Same-day discharge will be counted as 0, discharge on postoperative day 1 will be counted as 1, etc. A patient's readmission on the same day of discharge is considered a single continuous admission, unless the reason for readmission is clearly unrelated to the initial admission or surgery, in which case it will be considered a separate admission.
Non-home discharge
Non-home discharge will be identified as the postoperative hospital discharge to a nursing home or a rehabilitation center. Discharge to patient hotels will not be included. In addition, non-home discharge will not include patients who live in a nursing home prior to the surgery.
Surgical complications (Clavien-Dindo ≥2)
This outcome measures the incidence of adverse events after surgery and will be categorized based on the Clavien-Dindo classification grading system using the cut-off of ≥2; complications requiring pharmacological intervention (grade II), requiring additional procedures (grade III), life-threatening complications(grade IV) and a complication resulting in death (grade V).
Fall
: Patient reported or a fall noted in the electronic medical records.
Click on the lead sponsor to view all of their trials.
University of Iceland
Lead sponsor
Landspitali University Hospital
Collaborator