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BE-FIT Exercise Program for Post-Surgery Recovery in Older Patients (BE-FIT Trial)

N/A

Waitlist Available

Led By Rachel G Khadaroo, MD, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 65 or older

Patients admitted to hospital for surgical procedures such as general surgical, urologic, otolaryngologic, and transplant surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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).

Awards & highlights

BE-FIT Trial Summary

This trial is testing whether an exercise program can improve the recovery and discharge process for older patients from the hospital, and ultimately save money.

Who is the study for?

This trial is for individuals aged 65 or older who have been admitted to the hospital in Alberta, Canada for surgeries like general, urologic, otolaryngologic, and transplant procedures. It's not suitable for those transferred from other services, out-of-province patients, very frail individuals (Clinical Frailty Scale score ≥ 7), multi-system trauma or palliative surgery patients.Check my eligibility

What is being tested?

The BE-FIT program is being tested to see if it helps older adults recover faster after surgery by getting them moving sooner. Half of the participants will follow a bedside exercise plan during their hospital stay while the others receive usual care without this plan.See study design

What are the potential side effects?

Since BE-FIT involves physical activity designed for post-surgery recovery, potential side effects may include typical risks associated with exercise such as muscle soreness or strain. However, these exercises are tailored to be safe and beneficial for elderly surgical patients.

BE-FIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

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I am in the hospital for surgery, such as general, urologic, ear/nose/throat, or transplant surgery.

BE-FIT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The change in percentage of 'Out of bed' observations

Secondary outcome measures

Complication incidence

Hospitalization cost

Length of stay

+2 more

BE-FIT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BE-FITExperimental Treatment1 Intervention

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.

Group II: Usual careActive Control1 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).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryOTHER

791 Previous Clinical Trials

866,554 Total Patients Enrolled

6 Trials studying Surgery

8,214 Patients Enrolled for Surgery

University of AlbertaLead Sponsor

886 Previous Clinical Trials

382,598 Total Patients Enrolled

7 Trials studying Surgery

1,287 Patients Enrolled for Surgery

Rachel G Khadaroo, MD, PhDPrincipal InvestigatorUniversity of Alberta

Media Library

BE-FIT exercise program Clinical Trial Eligibility Overview. Trial Name: NCT05338528 — N/A

Surgery Research Study Groups: BE-FIT, Usual care

Surgery Clinical Trial 2023: BE-FIT exercise program Highlights & Side Effects. Trial Name: NCT05338528 — N/A

BE-FIT exercise program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05338528 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment offer opportunities for enrolment?

"According to the registries of clinicaltrials.gov, this medicinal trial is not currently accepting applicants. The original post date was August 1st 2021 and the last update occurred on April 23 2022. Although not actively recruiting for this specific study, there are presently 367 other medical studies which require participants."

Answered by AI

Could I be admitted to participate in this research endeavor?

"To be included in this investigation, participants must possess postoperative complications and range between 65 to 110 years old. This trial is looking for approximately 2180 individuals."

Answered by AI

Are those aged under 45 within the scope of this study?

"Eligibility for this trial extends to individuals aged 65-110. Additionally, there are 35 trials catering to those under 18 and 343 studies dedicated towards the senior population."

Answered by AI

Recent research and studies

JAMA SurgeryJournal

Clinical Effectiveness of the Elder-friendly Approaches to the Surgical Environment Initiative in Emergency General Surgery

Khadaroo, Rachel G., Lindsey M. Warkentin, Adrian S. Wagg, Raj S. Padwal, Fiona Clement, Xiaoming Wang, William D. Buie, and Jayna Holroyd-Leduc. 2020. “Clinical Effectiveness of the Elder-friendly Approaches to the Surgical Environment Initiative in Emergency General Surgery”. JAMA Surgery. American Medical Association (AMA). doi:10.1001/jamasurg.2019.6021.

World Journal of Emergency SurgeryJournal

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

McComb, Alyssa, Lindsey M. Warkentin, Margaret L. McNeely, and Rachel G. Khadaroo. 2018. “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 Journal of Emergency Surgery. Springer Science and Business Media LLC. doi:10.1186/s13017-018-0180-7.

Plos OneJournal

The Impact of Delayed Mobilization on Post-discharge Outcomes After Emergency Abdominal Surgery: A Prospective Cohort Study in Older Patients

Pederson, Jenelle L., Raj S. Padwal, Lindsey M. Warkentin, Jayna M. Holroyd-Leduc, Adrian Wagg, and Rachel G. Khadaroo. 2020. “The Impact of Delayed Mobilization on Post-discharge Outcomes After Emergency Abdominal Surgery: A Prospective Cohort Study in Older Patients”. Edited by Itamar Ashkenazi. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0241554.

JAMA Network OpenJournal