This study evaluates the feasibility of a short-term, digitally supported prehabilitation program for patients scheduled for elective total knee replacement (TKR). Osteoarthritis is a leading cause of disability, and recovery following TKR remains heterogeneous, with a substantial proportion of patients experiencing delayed functional recovery. Prehabilitation may improve perioperative outcomes, but its implementation is often limited by short preoperative time windows.
The Prehab2Rehab-KneeTEP trial is a single-center, two-arm, randomized controlled feasibility study conducted in Austria. Patients will be randomized (1:1) to either a multimodal video-supported prehabilitation program or usual care. The intervention consists of a 10 to 14-day preoperative exercise program including strength, endurance, coordination, and gait training, supported by a digital application, and is complemented by a digitally supported transition phase after hospital discharge until the start of inpatient rehabilitation.
The primary objective is to assess feasibility in terms of recruitment, retention, adherence, fidelity, acceptability, and safety. Secondary exploratory outcomes include clinical recovery indicators, functional performance, and patient-reported outcomes assessed across the perioperative pathway.
Age ≥18 years at the time of enrolment.
Clinically diagnosed with advanced osteoarthritis and with a medical indication for elective TKR.
Either a scheduled surgery or a documented intention to undergo TKR within the recruitment period.
Elective surgery is scheduled for at least 14 days after enrolment to allow completion of the 10 to 14-day prehabilitation intervention.
Pregnancy at the time of enrolment.
Emergency, revisional, or non-elective surgery.
Surgery scheduled less than 14 days after enrolment.
Severe physical impairment or medical contraindication to exercise training (e.g., unstable cardiovascular disease, uncontrolled hypertension, acute musculoskeletal injury).
Parallel
EXERCISE TRAINING WITH OR WITHOUT MEDICATION
BehavioralA short-term multimodal, video-supported prehabilitation program delivered over 10 to 14 days before surgery, including endurance, resistance, coordination, and gait training with crutches. The intervention is introduced during an in-person session and subsequently performed at home using a digital application to provide structured exercise guidance and support adherence. A single teleconsultation is conducted to ensure safety, provide feedback, and allow individualized progression. In addition, digital support is extended into the early post-discharge transition phase, providing low-threshold exercise guidance and educational content to support mobility, self-efficacy, and continuity of care until the start of inpatient rehabilitation.
Usual Care Group
Other interventionParticipants allocated to the usual care group will receive the standard perioperative treatment provided at the study site. This includes preoperative consultation, elective total knee replacement surgery according to institutional standards, and routine postoperative care. After hospital discharge, participants return home until the start of standardized inpatient rehabilitation (Phase II), including interdisciplinary care such as physiotherapy, occupational therapy, medical supervision, and health education. No structured prehabilitation or digitally supported intervention will be provided.
Recruitment rate
The recruitment rate will be calculated as the percentage of eligible patients who consent to participate in the study. The reported value will be: (number of enrolled participants / number of eligible patients) × 100%.
Retention Rate
Retention will be measured as the percentage of enrolled participants who complete all required study procedures. The reported value will be: (number of participants completing the study / number of enrolled participants) × 100%.
Adherence to the Intervention
Adherence will be defined as the proportion of prescribed prehabilitation sessions that participants complete. The reported value will be: (number of completed sessions / number of prescribed sessions) × 100%.
Completeness of Outcome Data
Completeness of data will be assessed as the percentage of planned outcome assessments that are successfully completed and available for analysis. The reported value will be: (number of completed assessments / number of planned assessments) × 100%.
Health Assessment Questionnaire (HAQ)
Patient-reported outcome assessing functional ability in activities of daily living using the HAQ score. The instrument captures disability across multiple domains including dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities. Total HAQ scores range from 0 to 3, with higher scores indicating greater functional impairment and lower functional status. The HAQ is used to evaluate changes in patient-reported functional status across the perioperative pathway.
Barthel-Index (BI)
Observer-based outcome assessing functional independence in activities of daily living using the Barthel Index (BI). The instrument evaluates performance in domains including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers, mobility, and stair use. Total BI scores range from 0 to 100, with higher scores indicating greater functional independence and lower dependency. The BI is used to evaluate changes in functional independence across the perioperative pathway.
Oxford Knee Score (OKS)
Patient-reported outcome assessing knee-specific pain and functional status using the OKS score. The instrument captures difficulties in activities such as walking, standing, and rising from a seated position. Scores are calculated according to standard OKS procedures, with higher values indicating better knee function and lower symptom burden. The OKS is used to evaluate changes in knee-related symptoms and function across the perioperative pathway.
Patient Health Questionnaire-4 (PHQ-4)
Patient-reported outcome assessing symptoms of anxiety and depression (PHQ-4). Total score ranges from 0 to 12, with higher values indicating greater psychological distress. Used to monitor changes in psychological well-being across the perioperative pathway.
Unified Theory of Acceptance and Use of Technology (UTAUT-2)
Assesses user acceptance and behavioral intention to use digital health technologies, including perceived usefulness, ease of use, and facilitating conditions.
mHealth App Usability Questionnaire (MAUQ)
Usability of the digital intervention will be assessed MAUQ, a validated instrument designed to evaluate usability, ease of use, and satisfaction with mobile health applications. Items are rated on a 7-point Likert scale ranging from 1 = strongly disagree to 7 = strongly agree. Responses are aggregated according to standard scoring procedures to calculate a mean total score, with higher scores indicating greater perceived usability.
Mobile App Rating Scale (MARS)
The quality of the mobile health application will be assessed using the Mobile App Rating Scale (MARS). The instrument includes four domains (engagement, functionality, aesthetics, and information quality), but the outcome will be reported as a single composite score calculated as the mean of all MARS items, each rated on a 5-point Likert scale. Total scores range from 1 to 5, with higher scores indicating better perceived app quality.
Perceived hedonic and pragmatic quality (AttrakDiff)
The AttrakDiff questionnaire assesses user experience of the digital intervention, including pragmatic quality (usability), hedonic quality (stimulation and identification), and overall attractiveness. Items are rated on a 7-point semantic differential scale ranging from -3 to +3. Scores are aggregated according to standard procedures to calculate overall and subscale scores, with higher values indicating more positive user experience.
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Ludwig Boltzmann Institute for Digital Health and Prevention
Lead sponsor
Paracelsus Medical University
Collaborator
Medizinische Zentrum Bad Vigaun GmbH & Co. KG
Collaborator
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