Prehabilitation Program for Frailty

Overseen By Viviana Camacho

Age: 18+

Sex: Any

Trial Phase: Academic

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a prehabilitation program (also known as an exercise program, preoperative rehabilitation, or pre-surgical conditioning) aimed at helping adults who are pre-frail or frail and require thoracic surgery. The goal is to determine if this program can improve patient outcomes by better preparing them for surgery. The trial will assess the program's usability and effectiveness for participants. Individuals planning to undergo lung surgery using methods like thoracotomy or robotic-assisted surgery may be suitable candidates. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance surgical outcomes for future patients.

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 prior data suggests that this prehabilitation program is safe for pre-frail and frail adults undergoing thoracic surgery?

Research has shown that prehabilitation programs are generally safe for people preparing for surgery. In one study, 84% of participants completed the program before their surgery without major problems. Another study found that these programs can help shorten hospital stays and reduce the risk of complications. Importantly, they have improved physical abilities, which might aid recovery after surgery. Overall, evidence suggests that prehabilitation is well-tolerated and beneficial for those who are frail or nearly frail and facing surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Prehabilitation Program for frailty because it takes a proactive approach to strengthening patients before they undergo surgery or treatment. Unlike traditional methods that often focus on rehabilitation after a procedure, this program aims to enhance physical and mental resilience in advance. By improving fitness, nutrition, and psychological readiness beforehand, the program potentially reduces complications and speeds up recovery. This forward-thinking strategy could revolutionize how we prepare frail individuals for medical interventions, ultimately improving outcomes and quality of life.

What evidence suggests that the Prehabilitation Program is effective for frailty?

Research has shown that prehabilitation programs, like the one studied in this trial, can improve outcomes after major surgeries. Studies have found that exercising before surgery increases strength and aids recovery. These programs particularly benefit frail, older adults by reducing the risk of losing physical abilities. Evidence also suggests that performing prehabilitation exercises at home helps maintain physical function. Overall, prehabilitation aims to better prepare patients, potentially leading to smoother recoveries. ^{5 6 7 8 9}

Who Is on the Research Team?

Maria L Madariaga, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10683858/

Preoperative Rehabilitation Is Feasible in the Weeks Prior ... Prior research demonstrates that rehabilitation strategies deployed after surgery improve outcomes by building strength.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8487197/

Pre-admission interventions (prehabilitation) to improve ... To determine the benefits and harms of pre-admission interventions (prehabilitation) on postoperative outcomes in patients undergoing major elective surgery.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999302048384

A prehabilitation program for physically frail community ... The effectiveness of exercise interventions for the management of frailty: A systematic review. 2011, Journal of Aging Research. Recovery of activities of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02934230

The Prehabilitation Study: Exercise Before Surgery to ... The role of preoperative exercise training (prehabilitation) in improving postoperative outcomes is a priority research area in perioperative medicine, and ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa020423

A Program to Prevent Functional Decline in Physically Frail ... A home-based program targeting underlying impairments in physical abilities can reduce the progression of functional decline among physically frail, elderly ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38008976/

Preoperative Rehabilitation Is Feasible in the Weeks Prior to ... Results: 43 patients completed baseline assessments; 36(84%) completed a median 5(range 3-10) weeks of prehabilitation before surgery; 32(74%) were retained ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06857981

Patient's Database: Prepare for Your Surgery Program ... Recent studies indicate that prehabilitation may lead to shorter hospital length of stay (LOS) and fewer complications. Recognizing the vital role that frailty ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2260134124000471

Preoperative Rehabilitation Is Feasible in the Weeks Prior ... Prehabilitation is feasible before major surgery and achieves clinically meaningful improvements in functional performance that may impact postoperative ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12638108/

A prehabilitation program for physically frail community-living ... A preventive, home-based physical therapy program (PREHAB) and to provide evidence for the safety and interrater reliability of the PREHAB protocol.