Knee OsteoarthristisP2R-KneeTEPNCT07621666
Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Knee Osteoarthristis and Total Knee Replacement, run by Ludwig Boltzmann Institute for Digital Health and Prevention at 1 site in Austria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthristis, Total Knee Replacement
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 15 Jul 2026to 1 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility will be determined during the outpatient consultations at the Medical
- Center in Bad Vigaun. Patients will be screened against the following criteria:
- 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.
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- Physical ability to safely perform the prescribed exercise program, as confirmed by the treating physician.
- Willingness to participate in a digitally supported training intervention at either the center or home-based.
- Sufficient digital literacy and access to internet-enabled devices (smartphone, tablet, or computer).
- Adequate German language proficiency to follow exercise instructions and study procedures.
Who cannot join
- Patients will be excluded if any of the following apply:
- 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).
- Patients with contraindications outlined in the Medizinisches Leistungsprofil (MLP) 2.0 that preclude rehabilitation and/or surgery.
- Participation in another clinical study that could interfere with the intervention or study outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medizinisches Zentrum Bad Vigaun GmbH & Co. KG
Hallein, State of Salzburg, 5424
Josef Sturm, Dr., +43 650 2040605, josef.sturm@badvigaun.com
Hildebert Hutt, Prim. Dr., +43 6245 8999 673, hildebert.hutt@badvigaun.com
About this study
Official title: Prehab2Rehab: Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement - A Randomized Controlled Feasibility Trial
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.
Read the detailed description
Total knee replacement (TKR) is an effective treatment for advanced knee osteoarthritis, yet postoperative recovery remains heterogeneous, with a substantial proportion of patients experiencing persistent functional limitations. Prehabilitation has the potential to optimize patients' physical and psychological readiness before surgery. However, in clinical practice, prehabilitation is often constrained by limited time between surgical indication and procedure. Digitally supported interventions may offer a feasible solution to deliver structured programs within short timeframes while supporting continuity of care across the perioperative pathway.
The Prehab2Rehab-KneeTEP trial is a single-center, randomized, two-arm feasibility study conducted at the Medizinisches Zentrum Bad Vigaun, Austria. The study aims to evaluate the feasibility, acceptability, and safety of a short-term, digitally supported prehabilitation intervention in patients scheduled for elective TKR.
Eligible patients with advanced knee osteoarthritis will be randomized in a 1:1 ratio following baseline assessment (PRE1) to either (i) a multimodal video-supported prehabilitation intervention with an additional digitally supported transition phase or (ii) usual care. Randomization will be performed using computer-generated permuted blocks with stratification for sex and baseline functional capacity assessed by the 6-minute walk test.
The intervention consists of a 10 to 14-day prehabilitation phase prior to surgery, including endurance, resistance, coordination, and gait training. The program is delivered through a combination of in-person instruction and home-based training supported by a digital application (aktivplan), which provides structured exercise guidance and enables documentation of adherence. A teleconsultation via a secure video platform (CAATS) is conducted to ensure exercise safety, provide feedback, and support progression. Sensor-based systems may be used for documentation and research-related measurements but are not used for clinical decision-making.
Following surgery and hospital discharge, participants in the intervention group enter a digitally supported transition phase lasting approximately 10 to 14 days until the start of inpatient rehabilitation (REH1). During this period, patients receive low-threshold exercise guidance and educational content via the digital application to support early recovery, maintain mobility, and promote self-efficacy. Participants in both groups receive standard surgical care and standardized inpatient rehabilitation according to institutional and national guidelines.
The total study participation duration is approximately 47 to 61 days, covering prehabilitation, hospital stay, transition, and rehabilitation phases. Outcomes are assessed at predefined time points along the perioperative pathway, including baseline (PRE1), end of prehabilitation (PRE2), hospital discharge, start of rehabilitation (REH1), and end of rehabilitation (REH2).
The primary objective is to assess feasibility across multiple domains, including recruitment, retention, adherence, fidelity, acceptability, usability of digital tools, and safety. Feasibility outcomes will be evaluated descriptively across process, resource, management, and participant engagement domains.
Secondary objectives are exploratory and include the assessment of clinical recovery indicators such as length of hospital stay, complication rate, and readmission rate, as well as patient-reported outcomes, anthropometric and body composition parameters, and functional performance measures. Given the feasibility nature of the trial, analyses will be descriptive and hypothesis-generating, without confirmatory statistical testing.
The findings of this study will inform the design and implementation of a future adequately powered randomized controlled trial evaluating the effectiveness of digitally supported prehabilitation in patients undergoing total knee replacement
- Conditions
- Knee Osteoarthristis, Total Knee Replacement
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION, Usual Care Group
- Keywords
- Prehabilitation, Digital Health, Exercise Therapy, Perioperative Care, Rehabilitation Pathway, Randomised Controlled Trial, Tele-rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONBehavioural
Also called Multimodal Prehabilitation Program
A 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 GroupOther
Also called Usual Care Control Group
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Other | Usual Care (Control). Participants receive standard preoperative, surgical, and postoperative care including standard inpatient rehabilitation without prehabilitation or digital support. Receives: Other: Usual Care Group |
| Multimodal Video-Supported Prehabilitation | Experimental | Multimodal Video-Supported Prehabilitation plus Digitally Supported Transition. Participants receive a 10 to 14-day multimodal prehabilitation program including endurance, resistance, coordination, and gait training, supported by the aktivplan application, one teleconsultation via CAATS, and research sensors for documentation. Digital support continues during the early post-discharge transition phase with low-threshold exercises and educational content until inpatient rehabilitation begins. Receives: Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Continuous throughout the recruitment period (12 months recruitment period)
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%.
Measured: Continuous throughout the data collection period (14 months data collection period)
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%.
Measured: During the intervention period (typically 2-4 weeks prior to surgery).
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%.
Measured: Continuous throughout data collection period (14 months)
Acceptability of the Intervention
Acceptability and usability of the digital intervention will be assessed using the mHealth App Usability Questionnaire (MAUQ). The MAUQ evaluates usability, satisfaction, ease of use, and perceived usefulness of mobile health applications. Items are rated on a 7-point Likert scale, ranging from 1 = strongly disagree to 7 = strongly agree. The outcome will be reported as the mean MAUQ score across completed questionnaires, with higher scores indicating greater perceived usability and acceptability.
Measured: At discharge from inpatient rehabilitation (REH2, approximately 6 to 8 weeks after surgery)
Secondary outcomes (19)
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.
Measured: Baseline, prehabilitation discharge (10-14 days after baseline, before surgery), rehabilitation admission (3-4 weeks after surgery), rehabilitation discharge (6-8 weeks after surgery).
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.
Measured: Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery)
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.
Measured: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery)
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.
Measured: Baseline (prior to intervention), after completion of prehabilitation (10-14 days after baseline, prior to surgery), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Patient-reported outcome assessing knee pain, stiffness, and physical function (WOMAC). Higher scores indicate worse symptoms and functional limitations. Used to evaluate changes across the perioperative rehabilitation pathway.
Measured: Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
EuroQol-5 Dimensions-5 Levels (EQ- 5D-5L)
The EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) is a standardized, patient-reported outcome measure assessing health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. Responses are converted into a health utility index score, with higher values indicating better health status. The instrument also includes a visual analogue scale (EQ-VAS), ranging from 0 to 100, with higher scores indicating better self-rated health.
Measured: Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline)), discharge (6-12 days post-surgery), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Rapid Assessment of Physical Activity (RAPA)
Self-reported questionnaire assessing level of physical activity (RAPA). Scores reflect engagement in aerobic and strength-based physical activity, with higher scores indicating higher activity levels. Used to evaluate changes in physical activity behavior across the perioperative pathway.
Measured: Baseline (prior to intervention), and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Exercise Self-Efficacy Scale (ESES)
Exercise Self-Efficacy Scale (ESES). Self-reported measure assessing confidence in the ability to perform and maintain physical activity. Total scores range from 10 to 40, with higher scores indicating greater exercise self-efficacy and therefore a better outcome. Used to evaluate changes in exercise-related confidence across the perioperative pathway.
Measured: Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline), discharge (6-12 days post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Body Fat Mass
Body fat mass measured using bioelectrical impedance analysis (BIA). Body fat mass represents the total amount of body fat and will be reported in kilograms (kg).
Measured: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Body Lean Mass
Body Lean Mass measured using bioelectrical impedance analysis (BIA). Body Lean Mass represents the total amount of non-fat body tissue and will be reported in kilograms (kg).
Measured: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Phase Angle
Phase angle measured using bioelectrical impedance analysis (BIA). Phase angle is a marker of cellular integrity and body cell mass and will be reported in degrees (°).
Measured: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
6-Minute Walk Test (6MWT)
The 6-Minute Walk Test (6MWT) is used to assess functional exercise capacity. Participants are instructed to walk as far as possible for six minutes along a standardized corridor, with distance covered recorded in meters. Standardized instructions and encouragement are provided according to established guidelines.
Measured: Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Timed Up and Go Test (TUG)
The Timed Up and Go Test (TUG) assesses functional mobility. Participants are instructed to stand up from a seated position, walk a short distance, turn, return, and sit down, with the total time recorded in seconds under standardized conditions.
Measured: Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Single-Leg Stance (SLS)
The Single-Leg Stance (SLS) test assesses static balance. Participants are instructed to stand on one leg for as long as possible under standardized conditions, with time recorded in seconds.
Measured: Baseline (prior to intervention), after prehab intervention (10-14 days after baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Fifteen-meter Gait Analysis with crutches (15-mGA+)
The Fifteen-meter Gait Analysis with crutches (15-mGA+) assesses gait performance under assisted walking conditions. Participants walk a standardized distance of 15 meters using crutches, with performance recorded under standardized conditions.
Measured: Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery).
Ten-meter Walk Test without crutches (10-mWT)
The Ten-meter Walk Test without crutches (10-mWT) assesses gait speed. Participants are instructed to walk a standardized distance of 10 meters without assistive devices, with time recorded under standardized conditions.
Measured: Baseline (prior to intervention), after prehab intervention (10-14 days after baseline), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Knee Range of Motion (ROM)
Knee Range of Motion (ROM) assesses joint mobility. Range of motion of the knee joint is measured in degrees under standardized conditions.
Measured: Baseline (prior to intervention), discharge (6-12 days post-surgery), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Lower limb strength (LLS)
Lower limb strength (LLS) assesses muscular strength of the lower extremities. Strength is measured using an isokinetic dynamometer (Biodex) under standardized conditions.
Measured: Baseline (prior to intervention), after prehab intervention (10-14 days after baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Handgrip strength (HG)
Handgrip strength (HG) assesses upper limb muscle strength using a handheld dynamometer under standardized conditions.
Measured: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start15 Jul 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthristisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in into two groups with a 1:1 ratio to either a multimodal video-supported prehabilitation intervention with a digitally supported transition phase or to usual care. Participants remain in their assigned group throughout the study.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Digital Health and Prevention
- Sponsor type
- University, hospital or other
- Collaborators
- Paracelsus Medical University, Medizinische Zentrum Bad Vigaun GmbH & Co. KG
- Responsible party
- Sponsor
- Investigators
- Daniela Wurhofer, Dr., Study director, Ludwig Boltzmann Institute for Digital Health and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621666
- Sponsor's protocol ID
- Prehab2Rehab-KneeTEP
- Other IDs
- Nr.1163/2025
- Acronym
- P2R-KneeTEP
- Status last verified
- May 2026
- First submitted
- 16 Apr 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared in order to protect participant confidentiality and in accordance with applicable data protection regulations, including the General Data Protection Regulation (GDPR). Only aggregated and fully anonymized data will be reported in scientific publications and presentations. No individual-level data will be made publicly available. Access to underlying data may be considered upon reasonable request and subject to institutional, ethical, and legal approval.
Publications
Wang L, Lee M, Zhang Z, Moodie J, Cheng D, Martin J. Does preoperative rehabilitation for patients planning to undergo joint replacement surgery improve outcomes? A systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2016 Feb 2;6(2):e009857. doi: 10.1136/bmjopen-2015-009857.
PubMed 26839013Adebero T, Omana H, Somerville L, Lanting B, Hunter SW. Effectiveness of prehabilitation on outcomes following total knee and hip arthroplasty for osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Disabil Rehabil. 2024 Dec;46(24):5771-5790. doi: 10.1080/09638288.2024.2313128. Epub 2024 Feb 13.
PubMed 38349251Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.
PubMed 31034380Nguyen C, Boutron I, Roren A, Anract P, Beaudreuil J, Biau D, Boisgard S, Daste C, Durand-Zaleski I, Eschalier B, Gil C, Lefevre-Colau MM, Nizard R, Perrodeau E, Rabetrano H, Richette P, Sanchez K, Zalc J, Coudeyre E, Rannou F. Effect of Prehabilitation Before Total Knee Replacement for Knee Osteoarthritis on Functional Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221462. doi: 10.1001/jamanetworkopen.2022.1462.
PubMed 35262716
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehab2Rehab: Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement - A Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT07621666
- Acronym / sponsor ID
- P2R-KneeTEP / Prehab2Rehab-KneeTEP
- Conditions
- Knee Osteoarthristis, Total Knee Replacement
- Keywords
- Prehabilitation, Digital Health, Exercise Therapy, Perioperative Care, Rehabilitation Pathway, Randomised Controlled Trial, Tele-rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ludwig Boltzmann Institute for Digital Health and PreventionUniversity, hospital or other
- Collaborators
- Paracelsus Medical University, Medizinische Zentrum Bad Vigaun GmbH & Co. KG
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 2 Jun 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.
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.
Detailed description
Total knee replacement (TKR) is an effective treatment for advanced knee osteoarthritis, yet postoperative recovery remains heterogeneous, with a substantial proportion of patients experiencing persistent functional limitations. Prehabilitation has the potential to optimize patients' physical and psychological readiness before surgery. However, in clinical practice, prehabilitation is often constrained by limited time between surgical indication and procedure. Digitally supported interventions may offer a feasible solution to deliver structured programs within short timeframes while supporting continuity of care across the perioperative pathway.
The Prehab2Rehab-KneeTEP trial is a single-center, randomized, two-arm feasibility study conducted at the Medizinisches Zentrum Bad Vigaun, Austria. The study aims to evaluate the feasibility, acceptability, and safety of a short-term, digitally supported prehabilitation intervention in patients scheduled for elective TKR.
Eligible patients with advanced knee osteoarthritis will be randomized in a 1:1 ratio following baseline assessment (PRE1) to either (i) a multimodal video-supported prehabilitation intervention with an additional digitally supported transition phase or (ii) usual care. Randomization will be performed using computer-generated permuted blocks with stratification for sex and baseline functional capacity assessed by the 6-minute walk test.
The intervention consists of a 10 to 14-day prehabilitation phase prior to surgery, including endurance, resistance, coordination, and gait training. The program is delivered through a combination of in-person instruction and home-based training supported by a digital application (aktivplan), which provides structured exercise guidance and enables documentation of adherence. A teleconsultation via a secure video platform (CAATS) is conducted to ensure exercise safety, provide feedback, and support progression. Sensor-based systems may be used for documentation and research-related measurements but are not used for clinical decision-making.
Following surgery and hospital discharge, participants in the intervention group enter a digitally supported transition phase lasting approximately 10 to 14 days until the start of inpatient rehabilitation (REH1). During this period, patients receive low-threshold exercise guidance and educational content via the digital application to support early recovery, maintain mobility, and promote self-efficacy. Participants in both groups receive standard surgical care and standardized inpatient rehabilitation according to institutional and national guidelines.
The total study participation duration is approximately 47 to 61 days, covering prehabilitation, hospital stay, transition, and rehabilitation phases. Outcomes are assessed at predefined time points along the perioperative pathway, including baseline (PRE1), end of prehabilitation (PRE2), hospital discharge, start of rehabilitation (REH1), and end of rehabilitation (REH2).
The primary objective is to assess feasibility across multiple domains, including recruitment, retention, adherence, fidelity, acceptability, usability of digital tools, and safety. Feasibility outcomes will be evaluated descriptively across process, resource, management, and participant engagement domains.
Secondary objectives are exploratory and include the assessment of clinical recovery indicators such as length of hospital stay, complication rate, and readmission rate, as well as patient-reported outcomes, anthropometric and body composition parameters, and functional performance measures. Given the feasibility nature of the trial, analyses will be descriptive and hypothesis-generating, without confirmatory statistical testing.
The findings of this study will inform the design and implementation of a future adequately powered randomized controlled trial evaluating the effectiveness of digitally supported prehabilitation in patients undergoing total knee replacement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in into two groups with a 1:1 ratio to either a multimodal video-supported prehabilitation intervention with a digitally supported transition phase or to usual care. Participants remain in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Usual care | Other | Other: Usual Care GroupUsual Care (Control). Participants receive standard preoperative, surgical, and postoperative care including standard inpatient rehabilitation without prehabilitation or digital support. |
| Multimodal Video-Supported Prehabilitation | Experimental | Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONMultimodal Video-Supported Prehabilitation plus Digitally Supported Transition. Participants receive a 10 to 14-day multimodal prehabilitation program including endurance, resistance, coordination, and gait training, supported by the aktivplan application, one teleconsultation via CAATS, and research sensors for documentation. Digital support continues during the early post-discharge transition phase with low-threshold exercises and educational content until inpatient rehabilitation begins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Eligibility will be determined during the outpatient consultations at the Medical
- 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.
Key exclusion criteria (7 listed)
- 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).
- Patients with contraindications outlined in the Medizinisches Leistungsprofil (MLP) 2.0 that preclude rehabilitation and/or surgery.
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 |
|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATIONAlso: Multimodal Prehabilitation ProgramA 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. | Behavioural | Multimodal Video-Supported Prehabilitation |
| Usual Care GroupAlso: Usual Care Control GroupParticipants 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. | Other | Usual care |
Primary outcome
Recruitment rate
Time frame: Continuous throughout the recruitment period (12 months recruitment period)
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
Time frame: Continuous throughout the data collection period (14 months data collection period)
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
Time frame: During the intervention period (typically 2-4 weeks prior to surgery).
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
Time frame: Continuous throughout data collection period (14 months)
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%.
Acceptability of the Intervention
Time frame: At discharge from inpatient rehabilitation (REH2, approximately 6 to 8 weeks after surgery)
Acceptability and usability of the digital intervention will be assessed using the mHealth App Usability Questionnaire (MAUQ). The MAUQ evaluates usability, satisfaction, ease of use, and perceived usefulness of mobile health applications. Items are rated on a 7-point Likert scale, ranging from 1 = strongly disagree to 7 = strongly agree. The outcome will be reported as the mean MAUQ score across completed questionnaires, with higher scores indicating greater perceived usability and acceptability.
19 secondary outcomes
Health Assessment Questionnaire (HAQ)
Time frame: Baseline, prehabilitation discharge (10-14 days after baseline, before surgery), rehabilitation admission (3-4 weeks after surgery), rehabilitation discharge (6-8 weeks after surgery).
Barthel-Index (BI)
Time frame: Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery)
Oxford Knee Score (OKS)
Time frame: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery)
Patient Health Questionnaire-4 (PHQ-4)
Time frame: Baseline (prior to intervention), after completion of prehabilitation (10-14 days after baseline, prior to surgery), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
EuroQol-5 Dimensions-5 Levels (EQ- 5D-5L)
Time frame: Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline)), discharge (6-12 days post-surgery), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Rapid Assessment of Physical Activity (RAPA)
Time frame: Baseline (prior to intervention), and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Exercise Self-Efficacy Scale (ESES)
Time frame: Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline), discharge (6-12 days post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Body Fat Mass
Time frame: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Body Lean Mass
Time frame: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Phase Angle
Time frame: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
6-Minute Walk Test (6MWT)
Time frame: Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Timed Up and Go Test (TUG)
Time frame: Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Single-Leg Stance (SLS)
Time frame: Baseline (prior to intervention), after prehab intervention (10-14 days after baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Fifteen-meter Gait Analysis with crutches (15-mGA+)
Time frame: Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery).
Ten-meter Walk Test without crutches (10-mWT)
Time frame: Baseline (prior to intervention), after prehab intervention (10-14 days after baseline), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Knee Range of Motion (ROM)
Time frame: Baseline (prior to intervention), discharge (6-12 days post-surgery), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Lower limb strength (LLS)
Time frame: Baseline (prior to intervention), after prehab intervention (10-14 days after baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Handgrip strength (HG)
Time frame: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
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 14 Jul 2026.
- Background: PubMed 26839013Wang L, Lee M, Zhang Z, Moodie J, Cheng D, Martin J. Does preoperative rehabilitation for patients planning to undergo joint replacement surgery improve outcomes? A systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2016 Feb 2;6(2):e009857. doi: 10.1136/bmjopen-2015-009857.
- Background: PubMed 38349251Adebero T, Omana H, Somerville L, Lanting B, Hunter SW. Effectiveness of prehabilitation on outcomes following total knee and hip arthroplasty for osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Disabil Rehabil. 2024 Dec;46(24):5771-5790. doi: 10.1080/09638288.2024.2313128. Epub 2024 Feb 13.
- Background: PubMed 31034380Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.
- Background: PubMed 35262716Nguyen C, Boutron I, Roren A, Anract P, Beaudreuil J, Biau D, Boisgard S, Daste C, Durand-Zaleski I, Eschalier B, Gil C, Lefevre-Colau MM, Nizard R, Perrodeau E, Rabetrano H, Richette P, Sanchez K, Zalc J, Coudeyre E, Rannou F. Effect of Prehabilitation Before Total Knee Replacement for Knee Osteoarthritis on Functional Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221462. doi: 10.1001/jamanetworkopen.2022.1462.
- Project website describing the Prehab2Rehab framework, including prehabilitation and rehabilitation concepts, study objectives, and institutional partners.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared in order to protect participant confidentiality and in accordance with applicable data protection regulations, including the General Data Protection Regulation (GDPR). Only aggregated and fully anonymized data will be reported in scientific publications and presentations. No individual-level data will be made publicly available. Access to underlying data may be considered upon reasonable request and subject to institutional, ethical, and legal approval.
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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.
Daniela Wurhofer, Dr. study director
Ludwig Boltzmann Institute for Digital Health and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Knee Osteoarthristis and Total Knee Replacement, run by Ludwig Boltzmann Institute for Digital Health and Prevention at 1 site in Austria.
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 10 inclusion and 7 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: opening soon, as of the sponsor's last update on 14 Jul 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 Austria. 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 Daniela Wurhofer, Dr. (+43 (0) 57 255 82702, daniela.wurhofer@lbg.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Continuous throughout the recruitment period (12 months recruitment period)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07621666, which also lists 4 linked publications.
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 14 Jul 2026.