Multimodal Prehabilitation of Frail Patients Undergoing Elective Knee or Hip Replacement

NCT07465159 | Not Yet Recruiting

• 1 other identifier: VSN2512023
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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-3L ), 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.

Conditions

Frailty Syndrome; Prehabilitation; Arthroplasties, Knee Replacement; Arthroplasties, Hip Replacement

Keywords

Frailty; Arthroplasty; Prehabilitation; Multimodal prehabilitation; Knee replacement; Hip replacement

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Out of all the patients screened the recruitment will be defined the proportion of patients who were randomized

  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

  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.

  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.

  Throughout the prehabilitation period, which is from enrollment to surgery (2-8 months)

Secondary Outcomes (7)

• - Preoperative optimization

  From enrollment until surgery (approximately 2-8 months)

• Change in health status (joint pain and function)

  Before prehabilitation and 3-6 months after surgery.

• Change in quality of life

  Before prehabilitation and 3-6 months after surgery.

• Nutritional adherence

  Throughout the prehabilitation period from enrollment until surgery (2-8 months).

• Four-stage balance test

  At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).

Other Outcomes (4)

• Length of hospital stay

  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.

• Non-home discharge

  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.

• Surgical complications (Clavien-Dindo ≥2)

  From the same day after surgery to postoperative day 30.

Study Arms (2)

Prehabilitation group

EXPERIMENTAL

This arm will undergo the intervention (multimodal prehabilitation).

Other: Multimodal Prehabilitation

Control group

NO INTERVENTION

This arm will be the control group and will not undergo the intervention (prehabilitation). The standard of care for patients undergoing elective prosthesis surgery who present at the perioperative services prior to surgery includes a preoperative appointment with a physiotherapist to guide postoperative recovery and the use of assistive devices, a consultation with a nurse to review preoperative hygiene measures such as showering, and a telephone consultation with an anesthetist for preoperative evaluation, risk assessment, and review of routine laboratory tests (e.g., blood work). As part of this process, medications, including blood thinners and anticoagulants, are adjusted as needed. In addition, patients receive education regarding perioperative management and anesthesia, with further work-up performed on an as-needed basis. Usually, patients present within 1-4 weeks before surgery.

Interventions

Multimodal Prehabilitation OTHER

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.

Also known as: Prehabilitation, Preoperative Optimization

Prehabilitation group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged 70 years or older assigned to undergo hip/knee replacement at Landspítali University Hospital.
• Patients who are willing to participate and sign informed consent and are willing to be randomized to the control or intervention arm.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iceland: lead
• Landspitali University Hospital: collaborator

MeSH Terms

Conditions

Frailty

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Martin I Sigurdsson, MD, PhD

CONTACT

+354-824-8282; mingi@hi.is

Luis G Rabelo, MD

CONTACT

+3548203587; lgr2@hi.is

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Anesthesiology and Intensive Care

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 11, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share