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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
The 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.
Landspitali University hospital
Reykjavik, Iceland
RECRUITINGRecruitment rate
Out of all the patients screened the recruitment will be defined the proportion of patients who were randomized
Time frame: During the inclusion time period, from enrollment of the first patient to the enrollment of the last patient or up to one year from the start of the study.
Retention rate
Out of all the patients randomized, the proportion of patients who complete follow-up
Time frame: The study period, from the randomization to 180-day 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.
Time frame: During the inclusion time period, from enrollment of the first patient to the enrollment of the last patient or up to one year from the start of the study.
Exercise adherence
Adherence to exercise prehabilitation, defined as completing ≥80% of the prescribed sessions or tasks.
Time frame: Throughout the prehabilitation period, which is from enrollment to surgery (2-8 months)
- 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.
Time frame: From enrollment until surgery (approximately 2-8 months)
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.
Time frame: Before prehabilitation and 3-6 months after surgery.
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).
Time frame: Before prehabilitation and 3-6 months after surgery.
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.
Time frame: Throughout the prehabilitation period from enrollment until surgery (2-8 months).
Four-stage balance test
Balance assessed using the four-stage balance test, measured as the ability to maintain progressively challenging standing positions: 1. Stand with your feet side-by-side 2. Place the instep of one foot so it is touching the big toe of the other foot. 3. Tandem stance Place one foot in front of the other, heel touching toes 4. Stand on one foot. Not being able to hold the tandem stance (task number 3) for 10 seconds is an indication of increased risk of fall.
Time frame: At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).
30-second chair stand test
Lower body strength assessed using the 30-second chair stand test, measured as the number of full stands completed from a seated position within 30 seconds.
Time frame: At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).
Timed Up and Go test (TUG)
Mobility assessed using the Timed Up and Go test, measured as the time in seconds required to stand from a chair, walk 3 meters, turn, return, and sit down. Participants perform as fast as they can.
Time frame: At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).
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