Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: EXERCISE TRAINING WITH OR WITHOUT MEDICATION, Usual Care Group.
- Кому может быть актуально
- Состояния в реестре: Knee Osteoarthristis, Total Knee Replacement. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австрия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Prehab2Rehab: Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement - A Randomized Controlled Feasibility Trial
Обзор
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.
Подробное описание
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
Вмешательства
- Поведенческое EXERCISE TRAINING WITH OR WITHOUT MEDICATION
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, - Другое Usual Care 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 h
Первичные конечные точки
- Recruitment rate [Срок оценки: Continuous throughout the recruitment period (12 months recruitment period)]
- Retention Rate [Срок оценки: Continuous throughout the data collection period (14 months data collection period)]
- Adherence to the Intervention [Срок оценки: During the intervention period (typically 2-4 weeks prior to surgery).]
- Completeness of Outcome Data [Срок оценки: Continuous throughout data collection period (14 months)]
- Acceptability of the Intervention [Срок оценки: At discharge from inpatient rehabilitation (REH2, approximately 6 to 8 weeks after surgery)]
Вторичные конечные точки (12)
- Health Assessment Questionnaire (HAQ) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery)]
- Patient Health Questionnaire-4 (PHQ-4) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (prior to intervention), and discharge from inpatient rehabilitation (6-8 weeks post-surgery).]
- Exercise Self-Efficacy Scale (ESES) [Срок оценки: 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 [Срок оценки: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).]
- Body Lean Mass [Срок оценки: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).]
- Phase Angle [Срок оценки: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).]
- 6-Minute Walk Test (6MWT) [Срок оценки: Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).]
Критерии участия
Критерии включения
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.
Критерии исключения
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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Австрия · 1 центр
- Medizinisches Zentrum Bad Vigaun GmbH & Co. KG — Hallein
Публикации
- 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
- 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
- Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9. PMID 31034380
- 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 PMID 35262716
Идентификаторы
NCT: NCT07621666 · Prehab2Rehab-KneeTEP · Nr.1163/2025