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Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement (P2R-KneeTEP)

2026年7月13日 更新者：Ludwig Boltzmann Institute for Digital Health and Prevention

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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • オーストリア
    • State of Salzburg
      • Hallein、State of Salzburg、オーストリア、5424
        • Medizinisches Zentrum Bad Vigaun GmbH & Co. KG
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Hildebert Hutt, Prim. Dr.
        • 主任研究者：
          • Thomas Hofstädter, Prim. Dr.
        • 副調査官：
          • Josef Sturm, Dr.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

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.

Exclusion Criteria:

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
他の：Usual care
Usual Care (Control). Participants receive standard preoperative, surgical, and postoperative care including standard inpatient rehabilitation without prehabilitation or digital support.
他の：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 health education. No structured prehabilitation or digitally supported intervention will be provided.
他の名前：
  • Usual Care Control Group
実験的：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.
行動：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, 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.
他の名前：
  • Multimodal Prehabilitation Program

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Recruitment rate
時間枠：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%.
Continuous throughout the recruitment period (12 months recruitment period)
Retention Rate
時間枠：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%.
Continuous throughout the data collection period (14 months data collection period)
Adherence to the Intervention
時間枠：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%.
During the intervention period (typically 2-4 weeks prior to surgery).
Completeness of Outcome Data
時間枠：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%.
Continuous throughout data collection period (14 months)
Acceptability of the Intervention
時間枠：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.
At discharge from inpatient rehabilitation (REH2, approximately 6 to 8 weeks after surgery)

二次結果の測定

結果測定
メジャーの説明
時間枠
Health Assessment Questionnaire (HAQ)
時間枠：Baseline, prehabilitation discharge (10-14 days after baseline, before surgery), rehabilitation admission (3-4 weeks after surgery), rehabilitation discharge (6-8 weeks after surgery).
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.
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)
時間枠：Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery)
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.
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)
時間枠：Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery)
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.
Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery)
Patient Health Questionnaire-4 (PHQ-4)
時間枠：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)
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.
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)
時間枠：Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
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.
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)
時間枠：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).
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.
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)
時間枠：Baseline (prior to intervention), and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
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.
Baseline (prior to intervention), and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Exercise Self-Efficacy Scale (ESES)
時間枠：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).
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.
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
時間枠：Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
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).
Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Body Lean Mass
時間枠：Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
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).
Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Phase Angle
時間枠：Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
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 (°).
Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
6-Minute Walk Test (6MWT)
時間枠：Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
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.
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)
時間枠：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).
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.
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)
時間枠：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).
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.
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+)
時間枠：Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery).
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.
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)
時間枠：Baseline (prior to intervention), after prehab intervention (10-14 days after baseline), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
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.
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)
時間枠：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).
Knee Range of Motion (ROM) assesses joint mobility. Range of motion of the knee joint is measured in degrees under standardized conditions.
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)
時間枠：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).
Lower limb strength (LLS) assesses muscular strength of the lower extremities. Strength is measured using an isokinetic dynamometer (Biodex) under standardized conditions.
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)
時間枠：Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Handgrip strength (HG) assesses upper limb muscle strength using a handheld dynamometer under standardized conditions.
Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).

その他の成果指標

結果測定
メジャーの説明
時間枠
Unified Theory of Acceptance and Use of Technology (UTAUT-2)
時間枠：At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Assesses user acceptance and behavioral intention to use digital health technologies, including perceived usefulness, ease of use, and facilitating conditions.
At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
mHealth App Usability Questionnaire (MAUQ)
時間枠：At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
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.
At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Mobile App Rating Scale (MARS)
時間枠：At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
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.
At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Perceived hedonic and pragmatic quality (AttrakDiff)
時間枠：At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
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.
At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Affinity for Technology Interaction (ATI)
時間枠：At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
The Affinity for Technology Interaction (ATI) Scale will be used to measure individuals' tendency to interact with and use technology in daily life. The scale consists of multiple items rated on a 6-point Likert scale (1 = completely disagree to 6 = completely agree). A mean total score will be calculated as the outcome measure. Higher scores indicate greater affinity for technology interaction.
At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Structured interviews
時間枠：At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Structured interviews will be conducted to qualitatively explore patient experiences, acceptability, usability, and perceived usefulness of the digitally supported intervention throughout the perioperative pathway. Interview responses will be analyzed descriptively to identify common themes related to patient experiences with the intervention. No numerical score will be calculated.
At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Ludwig Boltzmann Institute for Digital Health and Prevention

協力者

Paracelsus Medical University
Medizinische Zentrum Bad Vigaun GmbH & Co. KG

捜査官

  • スタディディレクター：Daniela Wurhofer, Dr.、Ludwig Boltzmann Institute for Digital Health and Prevention

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月15日

一次修了 (推定)

2027年4月1日

研究の完了 (推定)

2027年5月1日

試験登録日

最初に提出

2026年4月16日

QC基準を満たした最初の提出物

2026年5月29日

最初の投稿 (実際)

2026年6月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月14日

QC基準を満たした最後の更新が送信されました

2026年7月13日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Prehab2Rehab-KneeTEP
  • Nr.1163/2025 (その他の識別子：Ethics Committee of the State of Salzburg)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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