Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:12 AM
Study NCT ID:
NCT07465159
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Prehabilitation of Frail Patients Undergoing Elective Knee or Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '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.', 'description': "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."}, {'measure': 'Non-home discharge', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Surgical complications (Clavien-Dindo ≥2)', 'timeFrame': 'From the same day after surgery to postoperative day 30.', 'description': '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).'}, {'measure': 'Fall', 'timeFrame': 'From the same day of surgery to 3-6 months of follow-up', 'description': ': Patient reported or a fall noted in the electronic medical records.'}], 'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': '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.', 'description': 'Out of all the patients screened the recruitment will be defined the proportion of patients who were randomized'}, {'measure': 'Retention rate', 'timeFrame': 'The study period, from the randomization to 180-day follow-up', 'description': 'Out of all the patients randomized, the proportion of patients who complete follow-up'}, {'measure': 'Overall enrollment yield', 'timeFrame': '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.', 'description': 'Proportion of all patients invited for frailty screening (≥70 years and scheduled for arthroplasty) who are ultimately randomised into the trial.'}, {'measure': 'Exercise adherence', 'timeFrame': 'Throughout the prehabilitation period, which is from enrollment to surgery (2-8 months)', 'description': 'Adherence to exercise prehabilitation, defined as completing ≥80% of the prescribed sessions or tasks.'}], 'secondaryOutcomes': [{'measure': '- Preoperative optimization', 'timeFrame': 'From enrollment until surgery (approximately 2-8 months)', 'description': '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.'}, {'measure': 'Change in health status (joint pain and function)', 'timeFrame': 'Before prehabilitation and 3-6 months after surgery.', 'description': '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.'}, {'measure': 'Change in quality of life', 'timeFrame': 'Before prehabilitation and 3-6 months after surgery.', 'description': 'Quality of life assessed using the EuroQol 5-Dimension 3-Level questionnaire (EQ-5D-3L). The EQ-5D-3L includes five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).'}, {'measure': 'Nutritional adherence', 'timeFrame': 'Throughout the prehabilitation period from enrollment until surgery (2-8 months).', 'description': '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?"\n\nResponses will be recorded on a 5-point Likert scale:\n\n1. Never (0 days per week)\n2. Rarely (1-2 days per week)\n3. Sometimes (3-4 days per week)\n4. Often (5-6 days per week)\n5. Always (7 days per week)\n\nAn average score ≥4.0 will be considered adherent.'}, {'measure': 'Four-stage balance test', 'timeFrame': 'At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).', 'description': 'Balance assessed using the four-stage balance test, measured as the ability to maintain progressively challenging standing positions:\n\n1. Stand with your feet side-by-side\n2. Place the instep of one foot so it is touching the big toe of the other foot.\n3. Tandem stance Place one foot in front of the other, heel touching toes\n4. Stand on one foot.\n\nNot being able to hold the tandem stance (task number 3) for 10 seconds is an indication of increased risk of fall.'}, {'measure': '30-second chair stand test', 'timeFrame': 'At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).', 'description': '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.'}, {'measure': 'Timed Up and Go test (TUG)', 'timeFrame': 'At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frailty', 'Arthroplasty', 'Prehabilitation', 'Multimodal prehabilitation', 'Knee replacement', 'Hip replacement'], 'conditions': ['Frailty Syndrome', 'Prehabilitation', 'Arthroplasties, Knee Replacement', 'Arthroplasties, Hip Replacement']}, 'descriptionModule': {'briefSummary': '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.\n\nObjective: 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.\n\nMethods: 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.\n\nSignificance: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 70 years or older assigned to undergo hip/knee replacement at Landspítali University Hospital.\n* 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.\n* Patients who are willing to participate and sign informed consent and are willing to be randomized to the control or intervention arm.\n\nExclusion Criteria:\n\n* Patients who screen negative for all frailty tools will be excluded from the study.\n* Patients who are already in active physiotherapy, meeting with a physiotherapist \\>1 every month, will also be excluded.\n* In addition, those who do not undergo planned surgery, are undergoing redo hip/knee prosthesis replacement will be excluded'}, 'identificationModule': {'nctId': 'NCT07465159', 'briefTitle': 'Multimodal Prehabilitation of Frail Patients Undergoing Elective Knee or Hip Replacement', 'organization': {'class': 'OTHER', 'fullName': 'University of Iceland'}, 'officialTitle': 'Multimodal Prehabilitation of Frail Patients 70 Years and Older Undergoing Elective Knee or Hip Replacement: A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'VSN2512023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prehabilitation group', 'description': 'This arm will undergo the intervention (multimodal prehabilitation).', 'interventionNames': ['Other: Multimodal Prehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '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': [{'name': 'Multimodal Prehabilitation', 'type': 'OTHER', 'otherNames': ['Prehabilitation', 'Preoperative Optimization'], 'description': '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.\n\nAll 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.', 'armGroupLabels': ['Prehabilitation group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Martin I Sigurdsson, MD, PhD', 'role': 'CONTACT', 'email': 'mingi@hi.is', 'phone': '+354-824-8282'}, {'name': 'Luis G Rabelo, MD', 'role': 'CONTACT', 'email': 'lgr2@hi.is', 'phone': '+3548203587'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iceland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Landspitali University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Anesthesiology and Intensive Care', 'investigatorFullName': 'Martin Ingi Sigurdsson', 'investigatorAffiliation': 'University of Iceland'}}}}