Implementation and Assessment of the BE-FIT Program

NCT05338528 | Active Not Recruiting

• 1 other identifier: Pro00115917
• Study Type: interventional
• Target: 2,180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Complications; Mobility; Surgery

Keywords

Exercise, Postoperative, Surgery

Outcome Measures

Primary Outcomes (1)

• The change in percentage of 'Out of bed' observations

  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).

Secondary Outcomes (5)

• Time-to-mobility

  within 20 weeks post intervention

• Length of stay

  within 20 weeks post intervention

• Complication incidence

  within 20 weeks post intervention

• Hospitalization cost

  within 20 weeks post intervention

• Patient satisfaction

  within 20 weeks post intervention

Study Arms (2)

BE-FIT

EXPERIMENTAL

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.

Behavioral: BE-FIT exercise program

Usual care

NO INTERVENTION

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).

Interventions

BE-FIT exercise program BEHAVIORAL

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.

BE-FIT

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• University of Calgary: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

Related Publications (4)

• Khadaroo RG, Warkentin LM, Wagg AS, Padwal RS, Clement F, Wang X, Buie WD, Holroyd-Leduc J. Clinical Effectiveness of the Elder-Friendly Approaches to the Surgical Environment Initiative in Emergency General Surgery. JAMA Surg. 2020 Apr 1;155(4):e196021. doi: 10.1001/jamasurg.2019.6021. Epub 2020 Apr 15.

  PMID: 32049271 BACKGROUND

• Pederson JL, Padwal RS, Warkentin LM, Holroyd-Leduc JM, Wagg A, Khadaroo RG. The impact of delayed mobilization on post-discharge outcomes after emergency abdominal surgery: A prospective cohort study in older patients. PLoS One. 2020 Nov 6;15(11):e0241554. doi: 10.1371/journal.pone.0241554. eCollection 2020.

  PMID: 33156849 BACKGROUND

• Hofmeister M, Khadaroo RG, Holroyd-Leduc J, Padwal R, Wagg A, Warkentin L, Clement F. Cost-effectiveness Analysis of the Elder-Friendly Approaches to the Surgical Environment (EASE) Intervention for Emergency Abdominal Surgical Care of Adults Aged 65 Years and Older. JAMA Netw Open. 2020 Apr 1;3(4):e202034. doi: 10.1001/jamanetworkopen.2020.2034.

  PMID: 32242905 BACKGROUND

• McComb A, Warkentin LM, McNeely ML, Khadaroo RG. Development of a reconditioning program for elderly abdominal surgery patients: the Elder-friendly Approaches to the Surgical Environment-BEdside reconditioning for Functional ImprovemenTs (EASE-BE FIT) pilot study. World J Emerg Surg. 2018 May 21;13:21. doi: 10.1186/s13017-018-0180-7. eCollection 2018.

  PMID: 29942346 BACKGROUND

Related Links

• Dr. Khadaroo's Reserach Website

MeSH Terms

Conditions

Postoperative Complications; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Rachel G Khadaroo, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A quasi-experimental unblinded interrupted time-series (ITS) design in three phases: pre-intervention; during intervention; post-intervention. A before-and-after analysis methodology for complications, functional performance, and patient satisfaction.

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 21, 2022
• Study Start: August 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)