Landspitali University hospital
Reykjavik, 101, Iceland
Location status: Recruiting
NCT Number: NCT07465159
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.
Interested in participating?
Request Info70 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Prehabilitation, Preoperative Optimization
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.
Out of all the patients screened the recruitment will be defined the proportion of patients who were randomized
Time frame: 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
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.
Proportion of all patients invited for frailty screening (≥70 years and scheduled for arthroplasty) who are ultimately randomised into the trial.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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:
An average score ≥4.0 will be considered adherent.
Time frame: 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:
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).
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).
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: From the day of primary surgery until discharge from the index hospitalization (same-day discharge counted as 0 days), assessed up to 180 days postoperatively.
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.
Time frame: From the day of surgery (postoperative day 0) until discharge to a non-home destination or discharge from the primary hospitalization, whichever occurs first, assessed up to 180 days postoperatively.
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.
Time frame: From the same day after surgery to postoperative day 30.
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).
Time frame: From the same day of surgery to 3-6 months of follow-up
: Patient reported or a fall noted in the electronic medical records.
Contact information is provided by the study sponsor or research team.
Luis G Rabelo, MD
CONTACT
Martin I Sigurdsson, MD, PhD
CONTACT
University of Iceland
Other
Multimodal Prehabilitation of Frail Patients 70 Years and Older Undergoing Elective Knee or Hip Replacement: A Pilot Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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