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Implementatie en evaluatie van het BE-FIT-programma (BE-FIT)

22 september 2026 bijgewerkt door: University of Alberta

Implementatie en beoordeling van de ouderenvriendelijke BEdside-reconditionering voor functionele verbeteringen (BE-FIT) na chirurgische studie

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.

Studie Overzicht

Toestand

Actief, niet wervend

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

2180

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar tot 110 jaar (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

Geen tussenkomst: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The change in percentage of 'Out of bed' observations
Tijdsspanne: 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time-to-mobility
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: within 20 weeks post intervention

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

within 20 weeks post intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Medewerkers

Onderzoekers

  • Hoofdonderzoeker: Rachel G Khadaroo, MD, PhD, University of Alberta

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2021

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

30 september 2027

Studieregistratiedata

Eerst ingediend

10 april 2022

Eerst ingediend dat voldeed aan de QC-criteria

20 april 2022

Eerst geplaatst (Werkelijk)

21 april 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 september 2026

Laatste update ingediend die voldeed aan QC-criteria

22 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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