Multimodal Prehabilitation of Frail Patients Undergoing Elective Knee or Hip Replacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multimodal Prehabilitation.
- Who it may be relevant to
- Registry conditions: Frailty Syndrome, Prehabilitation, Arthroplasties, Knee Replacement, Arthroplasties, Hip Replacement. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iceland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multimodal Prehabilitation of Frail Patients 70 Years and Older Undergoing Elective Knee or Hip Replacement: A Pilot Randomized Controlled Trial
Overview
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
- Other Multimodal 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
Primary outcome measures
- Recruitment rate [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 [Time frame: The study period, from the randomization to 180-day follow-up]
- Overall enrollment yield [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 [Time frame: Throughout the prehabilitation period, which is from enrollment to surgery (2-8 months)]
Secondary outcome measures (7)
- - Preoperative optimization [Time frame: From enrollment until surgery (approximately 2-8 months)]
- Change in health status (joint pain and function) [Time frame: Before prehabilitation and 3-6 months after surgery.]
- Change in quality of life [Time frame: Before prehabilitation and 3-6 months after surgery.]
- Nutritional adherence [Time frame: Throughout the prehabilitation period from enrollment until surgery (2-8 months).]
- Four-stage balance test [Time frame: At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).]
- 30-second chair stand test [Time frame: At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).]
- Timed Up and Go test (TUG) [Time frame: At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Iceland · 1 center
- Landspitali University hospital — Reykjavik
Identifiers
NCT: NCT07465159 · VSN2512023