Prehabilitation Program for Frailty

Overseen By Viviana Camacho

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Chicago

Disqualifiers: Unable to consent, Non-English speakers, Age <17

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

Compensation: Varies

Number of Visits: 2

100 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.

What data supports the effectiveness of the Prehabilitation Program treatment for frailty?

Research suggests that prehabilitation, which includes exercise and other preparatory activities before surgery, can improve recovery and reduce complications for older adults with frailty undergoing surgery. This approach aims to boost physical reserves, helping patients better handle the stress of surgery and recover more effectively. ^{1 2 3 4 5}

Is the Prehabilitation Program for Frailty safe for humans?

Research suggests that prehabilitation, which includes exercise programs for people with frailty, is generally safe and may help reduce the risk of complications after surgery. It aims to improve physical reserves and reduce the likelihood of functional decline, enhancing recovery and quality of life. ^{1 2 3 4 6}

How is the Prehabilitation Program treatment different from other treatments for frailty?

The Prehabilitation Program is unique because it focuses on exercise and physical conditioning before surgery to improve the body's ability to recover, specifically targeting frail patients who are more vulnerable to surgical complications. Unlike other treatments that may address frailty after surgery, this program aims to enhance physical reserves and resilience beforehand, potentially reducing postoperative risks and improving recovery outcomes. ^{1 2 3 4 7}

What is the purpose of this trial?

The purpose of this study will be to implement and evaluate a prehab program for pre-frail and frail adults who need to undergo thoracic surgery. The study team hypothesizes using an implementation framework will increase the reach, effectiveness, adoption, and implementation of the prehab program.

Research Team

Maria L Madariaga, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for pre-frail and frail adults who are preparing for thoracic surgery. Participants should be able to follow a prehabilitation program using an Apple Watch Series 6 and exercise flipbook provided by the study.

Inclusion Criteria

Able to complete baseline evaluations at time of enrollment

I was identified as pre-frail or frail during my thoracic surgery assessment.

I am 50 years old or older.

Exclusion Criteria

I am under 50 years old.

I am unable to understand and agree to the study's details on my own.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants receive the prehab program from 2-12 weeks prior to undergoing elective inpatient thoracic surgery

2-12 weeks

Surgery

Participants undergo elective inpatient thoracic surgery

Follow-up

Participants are monitored for functional status and clinical outcomes after surgery

6 months

Surveys at 2-3 weeks, 2 months, 3-4 months, and 6 months after surgery

Treatment Details

Interventions

• Prehabilitation Program

Trial Overview The trial is testing a prehabilitation program designed to improve fitness before thoracic surgery. The program involves exercises tracked with an Apple Watch Series 6, along with guidance from an exercise flipbook.

Participant Groups

Group I: Prehabilitation Program Participant Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

This trial will assess the effectiveness of a home-based exercise prehabilitation program over 3 weeks for frail patients over 60 undergoing elective cancer surgery, aiming to improve their postoperative functional outcomes, particularly measured by the 6-minute walk test.

The study will also evaluate secondary outcomes such as quality of life and complications, providing a comprehensive understanding of how exercise prehabilitation can benefit frail older adults in the surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PREHAB study: a protocol for a prospective randomised clinical trial of exercise therapy for people living with frailty having cancer surgery. McIsaac, DI., Saunders, C., Hladkowicz, E., et al.[2022]

This trial will assess the effectiveness of a home-based multimodal prehabilitation program, including exercise and nutrition, in reducing postoperative complications and disability in older patients with frailty undergoing major surgery, involving 750 participants.

The study aims to demonstrate that prehabilitation can lead to significant improvements in patient-reported disability and a reduction in in-hospital complications, with a power of over 90% to detect meaningful differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PREPARE trial: a protocol for a multicentre randomised trial of frailty-focused preoperative exercise to decrease postoperative complication rates and disability scores. McIsaac, DI., Fergusson, DA., Khadaroo, R., et al.[2023]

Prehabilitation, particularly involving exercise and nutrition, shows high feasibility in frail surgical patients and may improve pre-operative functional capacity, but evidence for better post-operative recovery is lacking.

While some studies reported reductions in mortality and hospital stay duration with prehabilitation, the overall quality of evidence is very low, highlighting the need for more rigorous randomized controlled trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of prehabilitation in frail surgical patients: A systematic review. Milder, DA., Pillinger, NL., Kam, PCA.[2019]

A home-based prehabilitation program for older adults with frailty undergoing cancer surgery did not show significant improvements in postoperative recovery, as measured by the 6-minute walk test and other secondary outcomes, in a study involving 204 participants.

However, higher adherence to the prehabilitation program (≥80%) was associated with better outcomes, suggesting that how well patients follow the program may influence its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based prehabilitation with exercise to improve postoperative recovery for older adults with frailty having cancer surgery: the PREHAB randomised clinical trial. McIsaac, DI., Hladkowicz, E., Bryson, GL., et al.[2022]

Prehabilitation, which includes exercise, nutrition, and psychosocial counseling, may improve postoperative outcomes for frail surgical patients, as suggested by a review of five studies.

Despite the potential benefits of prehabilitation in reducing surgical risks, there is currently limited evidence supporting its widespread use, highlighting the need for more randomized controlled trials in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in Frail Surgical Patients: A Systematic Review. Baimas-George, M., Watson, M., Elhage, S., et al.[2021]

Frailty in older adults increases the risk of complications during and after surgery, but this condition can be improved through targeted therapeutic and medical interventions.

Prehabilitation, which includes these interventions, has been shown to reduce surgical complications, enhance rehabilitation, improve quality of life, and help maintain independence in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prehabilitation for Preparing Older People with Frailty for Surgery]. Kiselev, J., Schaller, SJ., Schmidt, K., et al.[2022]

In Germany, frailty assessments and structured prehabilitation approaches for patients over 65 years are not routinely implemented in surgical care, despite their potential to improve postoperative outcomes.

Multimodal prehabilitation concepts can positively influence the health outcomes of older patients by addressing frailty, which is often overlooked in current clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Are we missing the first step? : An online expert survey in a mixed methods design on current state analysis of perioperative risk estimation and preoperative preparation of patients over 65 years old in Germany]. Schindele, D., Suralis, A., Schlottke, C., et al.[2023]

References

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

PREHAB study: a protocol for a prospective randomised clinical trial of exercise therapy for people living with frailty having cancer surgery. [2022]

2. England pubmed.ncbi.nlm.nih.gov

PREPARE trial: a protocol for a multicentre randomised trial of frailty-focused preoperative exercise to decrease postoperative complication rates and disability scores. [2023]

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

The role of prehabilitation in frail surgical patients: A systematic review. [2019]

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

Home-based prehabilitation with exercise to improve postoperative recovery for older adults with frailty having cancer surgery: the PREHAB randomised clinical trial. [2022]

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

Prehabilitation in Frail Surgical Patients: A Systematic Review. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

[Prehabilitation for Preparing Older People with Frailty for Surgery]. [2022]

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

[Are we missing the first step? : An online expert survey in a mixed methods design on current state analysis of perioperative risk estimation and preoperative preparation of patients over 65 years old in Germany]. [2023]