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

2180 Participants Needed

Trial Summary

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 data supports the effectiveness of the BE-FIT exercise program treatment for post-surgery recovery in older patients?

Research shows that exercise programs before and after surgery can reduce complications and improve recovery in patients undergoing cancer surgeries, such as lung and abdominal surgeries. These findings suggest that similar exercise programs, like BE-FIT, could help older patients recover better after surgery. ^{1 2 3 4 5}

Is the BE-FIT Exercise Program safe for post-surgery recovery in older patients?

Exercise programs, including those for post-surgery recovery, have been studied for safety in various conditions. For example, a home-based exercise program was found to be safe for high-risk patients after cardiac surgery, and another study showed that exercise reduced complications and hospital stay for patients after cardiac surgery. These findings suggest that exercise programs can be safe for post-surgery recovery. ^{5 6 7 8 9}

How is the BE-FIT exercise program different from other treatments for post-surgery recovery in older patients?

The BE-FIT exercise program is unique because it focuses on a structured exercise regimen specifically designed for older patients recovering from surgery, aiming to restore muscle function and improve recovery outcomes. Unlike standard treatments, it emphasizes early post-surgery strength training and may be conducted in a home-based setting, which can be more convenient and accessible for older adults. ^{8 10 11 12 13}

What is the purpose of this trial?

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.

Research Team

Rachel G Khadaroo, MD, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Preoperative exercise halves the postoperative complication rate in patients with lung cancer: a systematic review of the effect of exercise on complications, length of stay and quality of life in patients with cancer. [2022]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effects of preoperative and postoperative resistance exercise interventions on recovery of physical function in patients undergoing abdominal surgery for cancer: a systematic review of randomised controlled trials. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Should we provide outreach rehabilitation to very old people living in Nursing Care Facilities after a hip fracture? A randomised controlled trial. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Community-based Exercise Prehabilitation for Patients Scheduled for Colorectal Surgery With High Risk for Postoperative Complications: Results of a Randomized Clinical Trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Validation of preoperative cardiopulmonary exercise testing-derived variables to predict in-hospital morbidity after major colorectal surgery. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Development process of an evidence-based exercise program for post-operative colorectal cancer patients. [2020]

8. England 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. [2008]

9. United States pubmed.ncbi.nlm.nih.gov

Exercise program for patients after cardiac surgery. [2004]

10. United States pubmed.ncbi.nlm.nih.gov

Home-Based Exercise in Older Adults Recently Discharged From the Hospital for Cardiovascular Disease in China: Randomized Clinical Trial. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Perioperative exercise programs improve early return of ambulatory function after total hip arthroplasty: a randomized, controlled trial. [2019]

12. Denmark pubmed.ncbi.nlm.nih.gov

[Older patients should be offered strength training early post surgery]. [2014]

13. South Africa pubmed.ncbi.nlm.nih.gov

The role of chair exercises for older adults following hip fracture. [2014]