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

(BE-FIT Trial)

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Out-of-province, Palliative surgery, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older adults recover better after surgery by encouraging earlier movement. It will test the BE-FIT exercise program, designed for bedside use to reduce muscle loss and improve recovery time. Participants will either follow this exercise program or receive regular care to compare results. The trial seeks patients aged 65 or older who have undergone surgeries such as general surgical, urologic, or transplant procedures. As an unphased trial, it offers participants the opportunity to contribute to innovative recovery strategies for older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on exercise and mobility for recovery.

What prior data suggests that the BE-FIT exercise program is safe for post-surgery recovery in older patients?

Research has shown that the BE-FIT exercise program is safe for older adults recovering from surgery. In a previous study, researchers found no harmful side effects. Another study confirmed that this type of exercise is safe and feasible, especially in a hospital setting for elderly patients. These findings suggest that the BE-FIT program is well-tolerated and can aid recovery without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BE-FIT exercise program for post-surgery recovery because it introduces a structured, phased approach to exercise specifically designed for older patients. Unlike typical post-surgery care, which often relies on general physiotherapy and independent activities like walking, BE-FIT is a comprehensive, time-sequenced intervention. It spans multiple weeks and is tailored to systematically improve functional performance and patient satisfaction. This method could potentially enhance recovery outcomes beyond what usual care can achieve, offering a more targeted way to support older patients in regaining their strength and mobility after surgery.

What evidence suggests that the BE-FIT exercise program is effective for post-surgery recovery in older patients?

Research has shown that exercise programs like BE-FIT, which participants in this trial will receive, can aid older adults in recovering better after surgery. Studies have found these programs to be safe and effective in improving physical abilities in older patients. Participants in similar programs reported completing most exercises and experiencing benefits. One study found that these exercises can shorten rehab time and lead to better overall recovery. This suggests that BE-FIT might help patients regain strength and reduce hospital stays. ^{2 4 5 6 7}

Who Is on the Research Team?

Rachel G Khadaroo, MD, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 65 years old or older.

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

Exclusion Criteria

Out-of-province

I have had surgery to ease symptoms.

Multi-system trauma patients

Timeline for a Trial Participant

Pre-intervention

Participants are assessed for baseline mobility and readiness for the BE-FIT program

10 weeks

Intervention

Participants receive the BE-FIT exercise program focusing on early mobilization and recovery

16 weeks

Post-intervention

Participants' mobility and functional outcomes are assessed after the intervention

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BE-FIT exercise program

Trial Overview

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.

How Is the Trial Designed?

Group I: BE-FIT Experimental Treatment 1 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 care Active Control 1 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).

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Published Research Related to This Trial

A self-monitored, home-based exercise program for high-risk cardiac surgery patients was found to be safe, with no cardiovascular complications reported during the eight-week training period.

However, the exercise program did not significantly improve aerobic capacity compared to a control group that received general activity guidelines, indicating that the home-based approach may not provide additional benefits in this specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of a self-monitored, home-based phase II exercise program for high risk patients after cardiac surgery. Brosseau, R., Juneau, M., Sirard, A., et al.[2008]

In a study of 109 elderly lung cancer patients, those who participated in enhanced recovery after surgery-based respiratory function exercises showed significant improvements in respiratory function and overall quality of life compared to those receiving only conventional care.

The exercise program also led to a lower incidence of pulmonary complications (5.26% in the exercise group vs. 21.15% in the control group), highlighting its effectiveness in promoting safer postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Enhanced Recovery After Surgery-Based Respiratory Function Exercise in Elderly Patients with Lung Cancer and its Effect on Postoperative Functional Recovery. Du, J., Wu, C., Li, A., et al.[2023]

A ten-step development process was used to create a safe and effective inpatient exercise program for colorectal cancer patients recovering from surgery, which included systematic reviews and expert discussions.

The exercise program significantly reduced the length of hospital stays and the time to flatus, indicating improved recovery outcomes for patients after colectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development process of an evidence-based exercise program for post-operative colorectal cancer patients. An, KY., In Yang, H., Kang, DW., et al.[2020]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29942346/

Development of a reconditioning program for elderly ...

BE FIT participants had a median of three rehab days and self-reported completing an average of 83% of the exercises. The adjusted between group difference ...

2.

wjes.biomedcentral.com

wjes.biomedcentral.com/articles/10.1186/s13017-018-0180-7

Development of a reconditioning program for elderly ...

The reconditioning program was shown to be safe and feasible within the hospital setting for the elderly emergency abdominal surgery patients.

3.

researchgate.net

researchgate.net/publication/325279716_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_

(PDF) Development of a reconditioning program for elderly ...

BE FIT participants had a median of three rehab days and self-reported completing an average of 83% of the exercises. The adjusted between group difference ...

4.

jamanetwork.com

jamanetwork.com/journals/jamasurgery/fullarticle/2760955

Clinical Effectiveness of the Elder-Friendly Approaches to ...

This study suggests that an elder-friendly approach to the surgical environment may be clinically effective in an emergency setting.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666756825000492

Effectiveness of post-discharge exercise interventions in ...

Our findings suggest that post-discharge exercise interventions are safe and effective in improving physical function in older adults following acute ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8986621/

Be Brave, BE-FIT! A Pilot Investigation of an ACT-informed ...

There were no adverse events reported. BE-FIT produced large-sized effects on reductions in exercise sensitivity and increases in both average steps/day and ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05338528

Implementation and Assessment of the BE-FIT Program

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 ...