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Mise en œuvre et évaluation du programme BE-FIT (BE-FIT)

22 septembre 2026 mis à jour par: University of Alberta

Mise en œuvre et évaluation de l'étude sur le reconditionnement au lit adapté aux personnes âgées pour les améliorations fonctionnelles (BE-FIT) après la chirurgie

Lengthy hospitalization and immobility can lead to muscle loss resulting in reduced recovery rates and prolonged hospital stay or readmission. Older adults discharged from hospitals are at an increased risk for functional decline, falls and disability. Daily exercise and physical activities have proven to enhance the recovery and discharge process for older patients from the hospital and ultimately save vast amounts of dollars each year. The aim of this study is to initiate early mobilization and decrease the rate of functional decline in post-surgical older adults' patients in the acute care hospital setting in Alberta, Canada. The investigators are implementing a BE-FIT (BEdside reconditioning for Functional ImprovemenTs) a quality improvement, evidence-based exercise program that focuses on early mobilization and recovery by minimizing bed rest, promoting functional tasks, and encouraging self-management. Patients enrolled in the program will receive a bedside exercise plan to be completed independently throughout their stay in the hospital. Control patients will receive usual care without the added exercise plan. Patient mobility during their hospital stay will be assessed pre and post BE-FIT initiation according to a predetermined mobility scoring system. Secondary outcomes will include: time-to-mobility, length of stay, complication incidence and hospitalization costs.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Description détaillée

Frailty and post-operative complications are the predictors of increased cost-of-care among older patients who underwent emergency abdominal surgery in Alberta. In addition, older patients are often more vulnerable to the physical stressors following major surgery including risks of falls and disability. There is increasing evidence that daily exercise and physical activities can enhance the recovery and discharge process for older patients. Employing a two-arm trial design we will test whether the initiation of an early mobilization program can decrease the rate of functional decline in post-surgical older adults' patients.

The trial will be conducted in an acute care hospital setting in Alberta, Canada. The investigators will implement a quality improvement program BE-FIT (Bedside reconditioning for functional improvements) based on the Mobilization of Vulnerable Elders (MOVE) implementation strategy. BE-FIT is an evidence-based exercise program that focuses on early mobilization and recovery by minimizing bed rest, promoting functional tasks, and encouraging self-management. The intervention consists of a bedside exercise plan completed throughout the hospitalization. It is done independently without the need for additional rehabilitation or healthcare staff. The investigators will implement educational intervention to support the patients, staff, and families in bringing and sustaining change in practice and behavior from sedentary to physically active mobilization approach in the surgical area of the acute care setting. Control patients will receive usual care without the added exercise plan.

BE-FIT will be implemented in surgical units at 3 demonstrator sites (University of Alberta Hospital (UAH), Foothills Medical Centre (FMC) and the Misericordia Community Hospital (MCH)). Units may include General surgery, Otolaryngologic surgery, and Urology. The research will include all patients ≥65 years admitted to the hospital (emergency or elective) units.

The study is guided by the Knowledge-to-Action Cycle theory (K2A) and the Quality Implementation Framework (QIF) with interrupted time-series (IT) design. Prior to the implementation of the program, the investigators will used readiness assessments, identification of facilitators and barriers to post-operative mobility and co-designs with patients will be conducted. To measure and analyze the impact of our program, the primary outcome will evaluate the percentage of 'out of bed' occurrences as measured by an interrupted time series of mobility audits; secondary outcomes will include: time-to-mobility, length of stay, complication incidence and hospitalization costs. The quasi-experimental unblinded interrupted time-series (ITS) design will be conducted in three phases: pre-intervention (10 weeks); during intervention (16 weeks); post-intervention (20 weeks). A pre-intervention model will be created by using the first time-points over 10 weeks to analyze the primary outcome. To evaluate whether this model describes the baseline adequately, an estimate of the time-series models for the entire 84-time points (pre- and post-intervention) will be performed. To examine the impact of the BE-FIT exercise program on patient outcome, the investigators will use segmented linear regression models and correct the models for autocorrelation as required using the Cochrane-Orcutt method. This will be used to calculate the median daily length-of-stay for each week in the study period, classified into pre-, during and post-intervention. Regression methods will be used to assess mobilization outcome to investigate and compare the trend in median length-of-stay. A before-and-after analysis methodology will be adopted for complications, functional performance, and patient satisfaction. Regression models will be constructed using the parsimonious approach, multivariable linear (or transformed linear) regression, and logistic regression. Potential confounding baseline variables (i.e., age, sex, patient location before admission, admitting diagnosis, etc.) will be entered into the model and kept if deemed statistically (p<0.05) and/or clinically important. Health economic assessment will estimate mean cost for different sub-categories using appropriate regressions models for skewed cost data, adjusted for potential risk differences. The impact on patient's function and quality-of-life will be assessed with Short Performance Physical Battery (SPPB) and EQ-5D questionnaires.

Type d'étude

Interventionnel

Inscription (Estimé)

2180

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R3
        • University of Alberta

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans à 110 ans (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • age 65 or older
  • patients admitted to hospital for surgical procedures such as general surgical, urologic, otolaryngologic, and transplant surgery

Exclusion Criteria:

  • non-index admissions (i.e., transferred from another inpatient service)
  • out-of-province
  • palliative surgery
  • multi-system trauma patients
  • patients with a Clinical Frailty Scale score ≥ 7

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: BE-FIT

The quasi-experimental unblinded interrupted time-series (ITS) design will be conducted in three phases: pre-intervention/ (10 weeks); during intervention (16 weeks); post-intervention (20 weeks). A cohort of patients on selected wards will receive the BE-FIT program intervention.

BE-FIT is an evidence-based exercise program that focuses on early mobilization and recovery by minimizing bed rest, promoting functional tasks, and encouraging self-management. The intervention ist based on the Mobilization of Vulnerable Elders (MOVE) program and consists of a bedside exercise plan, done independently by the patient without the need for additional rehabilitation or healthcare staff.

Aucune intervention: Usual care

We will adopt a before-and-after analysis methodology for complications, functional performance, and patient satisfaction. A control cohort of patients on the same ward will be compared to who received usual care prior to the intervention; this may include physiotherapy consultations ordered at the discretion of the surgical team or any other independent activity initiated by the patient (e.g., walking).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The change in percentage of 'Out of bed' observations
Délai: A quasi-experimental unblinded interrupted time-series (ITS) design will be conducted in three phases: pre-intervention/(10 weeks); during intervention (16 weeks); post-intervention (20 weeks).

The primary outcome is the change in percentage of 'out of bed' observations among older surgery patients assessed for baseline audits (Pre-intervention), compared to audits in the intervention phase, and compared to audits post-intervention. The research team will perform visual audits 6 times/week (three times/day, two days/week or two times/day, three times/week), and will record patient identification numbers and types of mobility observed using the MOVE's audit tool. Frequencies (percentage) of out-of-bed will be compared to frequencies (percentage) of in-bed events.

A quasi-experimental unblinded interrupted time-series (ITS) design will be conducted in three phases: pre-intervention/(10 weeks); during intervention (16 weeks); post-intervention (20 weeks).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time-to-mobility
Délai: within 20 weeks post intervention

Time-to-mobility will be obtained from the patient charts. Shorter time-to-mobility indicates better health

within 20 weeks post intervention
Length of stay
Délai: within 20 weeks post intervention

Length of stay will be obtained from the patient charts and DIMR. Reduced length of stay will indicate improved health

within 20 weeks post intervention
Complication incidence
Délai: within 20 weeks post intervention

Complication incidence will be obtained as assessed by a post-operative morbidity survey and DIMR. Less complication incidence will indicate a beneficial outcome of the quality improvement initiative.

within 20 weeks post intervention
Hospitalization cost
Délai: within 20 weeks post intervention

Hospitalization cost including in-hospital costs, readmissions at 30 days' post-discharge will be obtained by utilizing DIMR, Discharge Abstract Database and in-hospital micro-costing data from each site.

within 20 weeks post intervention
Patient satisfaction
Délai: within 20 weeks post intervention

patient satisfaction will be assessed by a patient satisfaction questionnaire (PSQ-18)

within 20 weeks post intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Les enquêteurs

  • Chercheur principal: Rachel G Khadaroo, MD, PhD, University of Alberta

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 août 2021

Achèvement primaire (Estimé)

30 juin 2027

Achèvement de l'étude (Estimé)

30 septembre 2027

Dates d'inscription aux études

Première soumission

10 avril 2022

Première soumission répondant aux critères de contrôle qualité

20 avril 2022

Première publication (Réel)

21 avril 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • Pro00115917

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

There are no plans to share IPD with other researchers outside the collaborator group

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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