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

13 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Austria
    • State of Salzburg
      • Hallein, State of Salzburg, Austria, 5424
        • Medizinisches Zentrum Bad Vigaun GmbH & Co. KG
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Hildebert Hutt, Prim. Dr.
        • Investigatore principale:
          • Thomas Hofstädter, Prim. Dr.
        • Sub-investigatore:
          • Josef Sturm, Dr.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Usual care
Usual Care (Control). Participants receive standard preoperative, surgical, and postoperative care including standard inpatient rehabilitation without prehabilitation or digital support.
Altro: 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.
Altri nomi:
  • Usual Care Control Group
Sperimentale: 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.
Comportamentale: 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.
Altri nomi:
  • Multimodal Prehabilitation Program

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Health Assessment Questionnaire (HAQ)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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+)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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).

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Unified Theory of Acceptance and Use of Technology (UTAUT-2)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ludwig Boltzmann Institute for Digital Health and Prevention

Collaboratori

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

Investigatori

  • Direttore dello studio: Daniela Wurhofer, Dr., Ludwig Boltzmann Institute for Digital Health and Prevention

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 luglio 2026

Completamento primario (Stimato)

1 aprile 2027

Completamento dello studio (Stimato)

1 maggio 2027

Date di iscrizione allo studio

Primo inviato

16 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 maggio 2026

Primo Inserito (Effettivo)

2 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 luglio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Prehab2Rehab-KneeTEP
  • Nr.1163/2025 (Altro identificatore: Ethics Committee of the State of Salzburg)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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