Arthroplasties, Hip Replacement, Arthroplasties, Knee Replacement, Frailty Syndrome, Prehabilitation
Conditions
Keywords
Frailty, Arthroplasty, Prehabilitation, Multimodal prehabilitation, Knee replacement, Hip replacement
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.
Interventions
OTHERMultimodal Prehabilitation
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.
Sponsors
University of Iceland
Landspitali University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients will be randomized either to prehabilitation or control arm. Analysis will be based on intention to treat. Patients will be randomized ensuring an equal distribution of hip and knee arthroplasty cases between groups.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 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. | Out of all the patients screened the recruitment will be defined the proportion of patients who were randomized |
| Retention rate | The study period, from the randomization to 180-day follow-up | Out of all the patients randomized, the proportion of patients who complete follow-up |
| Overall enrollment yield | 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. | Proportion of all patients invited for frailty screening (≥70 years and scheduled for arthroplasty) who are ultimately randomised into the trial. |
| Exercise adherence | Throughout the prehabilitation period, which is from enrollment to surgery (2-8 months) | Adherence to exercise prehabilitation, defined as completing ≥80% of the prescribed sessions or tasks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - Preoperative optimization | From enrollment until surgery (approximately 2-8 months) | 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) | Before prehabilitation and 3-6 months after surgery. | 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 | Before prehabilitation and 3-6 months after surgery. | 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 | Throughout the prehabilitation period from enrollment until surgery (2-8 months). | 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. |
| Four-stage balance test | At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months). | 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. |
| 30-second chair stand test | At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months). | 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. |
| Timed Up and Go test (TUG) | At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months). | 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. |
Countries
Iceland
Contacts
CONTACTMartin I Sigurdsson, MD, PhD
CONTACTLuis G Rabelo, MD
Outcome results
None listed