Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement

NCT07621666 | Not Yet Recruiting DMC

• 2 other identifiers: Prehab2Rehab-KneeTEPNr.1163/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Knee Osteoarthristis; Total Knee Replacement

Keywords

Prehabilitation; Digital Health; Exercise Therapy; Perioperative Care; Rehabilitation Pathway; Randomised Controlled Trial; Tele-rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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%.

  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%.

  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%.

  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%.

  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.

  At discharge from inpatient rehabilitation (REH2, approximately 6 to 8 weeks after surgery)

Secondary Outcomes (19)

• Health Assessment Questionnaire (HAQ)

  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)

  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)

  Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery)

• Patient Health Questionnaire-4 (PHQ-4)

  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)

  Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).

Other Outcomes (6)

• Unified Theory of Acceptance and Use of Technology (UTAUT-2)

  At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).

• mHealth App Usability Questionnaire (MAUQ)

  At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).

• Mobile App Rating Scale (MARS)

  At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).

Study Arms (2)

Usual care

OTHER

Usual Care (Control). Participants receive standard preoperative, surgical, and postoperative care including standard inpatient rehabilitation without prehabilitation or digital support.

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.

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Interventions

EXERCISE TRAINING WITH OR WITHOUT MEDICATION BEHAVIORAL

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.

Also known as: Multimodal Prehabilitation Program

Multimodal Video-Supported Prehabilitation

Usual Care Group OTHER

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.

Also known as: Usual Care Control Group

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paracelsus Medical University: collaborator
• Medizinische Zentrum Bad Vigaun GmbH & Co. KG: collaborator
• Ludwig Boltzmann Institute for Digital Health and Prevention: lead

Study Sites (1)

Medizinisches Zentrum Bad Vigaun GmbH & Co. KG

Hallein, State of Salzburg, 5424, Austria

Location

Related Publications (4)

• 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.

  PMID: 26839013 BACKGROUND

• Adebero 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.

  PMID: 38349251 BACKGROUND

• Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.

  PMID: 31034380 BACKGROUND

• Nguyen 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.

  PMID: 35262716 BACKGROUND

Related Links

• Project website describing the Prehab2Rehab framework, including prehabilitation and rehabilitation concepts, study objectives, and institutional partners.

MeSH Terms

Interventions

Exercise; Dosage Forms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Daniela Wurhofer, Dr.

  Ludwig Boltzmann Institute for Digital Health and Prevention

  STUDY DIRECTOR

Central Study Contacts

Daniela Wurhofer, Dr.

CONTACT

+43 (0) 57 255 82702; daniela.wurhofer@lbg.ac.at

Gunnar Treff, Univ.-Prof. Dr.

CONTACT

+43 5 7255 82711; gunnar.treff@pmu.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: June 2, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)