Prehab2Rehab: Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement - A Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Multimodal Video-Supported Prehabilitation
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.
干预措施: EXERCISE TRAINING WITH OR WITHOUT MEDICATION (Behavioral)
Usual care
Usual Care (Control). Participants receive standard preoperative, surgical, and postoperative care including standard inpatient rehabilitation without prehabilitation or digital support.
干预措施: Usual Care Group (Other)