Frailty SyndromeNCT07465159
Multimodal Prehabilitation of Frail Patients Undergoing Elective Knee or Hip Replacement
A study testing Multimodal Prehabilitation in people with Frailty Syndrome and Prehabilitation, run by University of Iceland at 1 site in Iceland.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty Syndrome, Prehabilitation, Arthroplasties, Knee Replacement
- What is being tested?
- Multimodal Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIceland
- Study dates
- 20 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iceland1 site, 1 recruiting
- Recruiting
Landspitali University hospital
Reykjavik, 101
Luis G Rabelo, MD, 8203587 ext. +354, lgr2@hi.is
Martin I Sigurdsson, MD, PhD, 8248282 ext. +354, martin@landspitali.is
About this study
Official title: Multimodal Prehabilitation of Frail Patients 70 Years and Older Undergoing Elective Knee or Hip Replacement: A Pilot Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Frailty Syndrome, Prehabilitation, Arthroplasties, Knee Replacement, Arthroplasties, Hip Replacement
- Being tested
- Multimodal Prehabilitation
- Keywords
- Frailty, Arthroplasty, Prehabilitation, Multimodal prehabilitation, Knee replacement, Hip replacement
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal PrehabilitationOther
Also called Prehabilitation, Preoperative Optimization
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.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation group | Experimental | This arm will undergo the intervention (multimodal prehabilitation). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Out of all the patients screened the recruitment will be defined the proportion of patients who were randomized
Measured: 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
Measured: 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.
Measured: 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.
Measured: Throughout the prehabilitation period, which is from enrollment to surgery (2-8 months)
Secondary outcomes (7)
- 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.
Measured: 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.
Measured: 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).
Measured: 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:
- Never (0 days per week)
- Rarely (1-2 days per week)
- Sometimes (3-4 days per week)
- Often (5-6 days per week)
- Always (7 days per week)
An average score ≥4.0 will be considered adherent.
Measured: 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:
- Stand with your feet side-by-side
- Place the instep of one foot so it is touching the big toe of the other foot.
- Tandem stance Place one foot in front of the other, heel touching toes
- 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.
Measured: 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.
Measured: 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.
Measured: At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start20 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Collaborators
- Landspitali University Hospital
- Responsible party
- Principal investigator, Martin Ingi Sigurdsson, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465159
- Sponsor's protocol ID
- VSN2512023
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data collected during this study will not be shared due to confidentiality. Additionally, there is no formal plan for making these data publicly available at this time.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Prehabilitation of Frail Patients 70 Years and Older Undergoing Elective Knee or Hip Replacement: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07465159
- Acronym / sponsor ID
- VSN2512023
- Conditions
- Frailty Syndrome, Prehabilitation, Arthroplasties, Knee Replacement, Arthroplasties, Hip Replacement
- Keywords
- Frailty, Arthroplasty, Prehabilitation, Multimodal prehabilitation, Knee replacement, Hip replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Collaborators
- Landspitali University Hospital
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation group | Experimental | Other: Multimodal PrehabilitationThis arm will undergo the intervention (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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal PrehabilitationAlso: Prehabilitation, Preoperative OptimizationThe 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 | Prehabilitation group |
Primary outcome
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.
Out of all the patients screened the recruitment will be defined the proportion of patients who were randomized
Retention rate
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
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.
Proportion of all patients invited for frailty screening (≥70 years and scheduled for arthroplasty) who are ultimately randomised into the trial.
Exercise adherence
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.
7 secondary outcomes
- 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No. The individual participant data collected during this study will not be shared due to confidentiality. Additionally, there is no formal plan for making these data publicly available at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Prehabilitation in people with Frailty Syndrome and Prehabilitation, run by University of Iceland at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin I Sigurdsson, MD, PhD (+354-824-8282, mingi@hi.is), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.