Exercise Program for Frailty in Lung Transplant Candidates

(XFIT Trial)

Not yet recruiting at 3 trial locations

Overseen By Legna Betancourt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Lives alone, BMI < 18, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-based exercise program called XFIT to determine its safety and effectiveness for people who are frail and awaiting a lung transplant. Researchers aim to assess whether telehealth exercises are safe, easy to follow, and beneficial for improving frailty and physical function. Participants will either engage in the XFIT program or receive enhanced standard care, which includes personalized advice but no weekly sessions. Suitable candidates for this trial are lung transplant candidates who speak English or Spanish, use oxygen support, and are not currently enrolled in a pulmonary rehab program. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance pre-transplant care.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the XFIT program is safe for lung transplant candidates?

Previous studies have shown that similar exercise programs are safe and well-tolerated by participants. These programs often help people become stronger and healthier without causing serious side effects. The XFIT program is designed for safety, allowing participants to exercise from home using telehealth. This setup reduces the risk of injury compared to more intense exercise routines. While this trial focuses on safety, the telehealth method and training components have been used successfully in similar situations without major issues. Overall, this suggests that the XFIT program is likely safe for lung transplant candidates dealing with frailty. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for frailty in lung transplant candidates, which typically involves general recommendations and information, XFIT offers a personalized and interactive approach. XFIT is unique because it is an 8-week telehealth program that combines home-based exercise with behavior modification techniques, specifically designed to engage and prepare frail patients for lung transplants. Researchers are excited about XFIT because it integrates behavioral change theories to enhance patient engagement and could significantly improve physical frailty more effectively than traditional methods. This individualized, telehealth-delivered intervention allows for greater accessibility and convenience, potentially leading to better outcomes for those awaiting transplants.

What evidence suggests that the XFIT program is effective for treating frailty in lung transplant candidates?

This trial will compare the XFIT exercise program with enhanced standard care for frailty in lung transplant candidates. Studies have shown that exercise programs can improve frailty in those awaiting a lung transplant. Research indicates that frailty affects about one-third of these candidates, leading to more health problems. The XFIT program, which participants in this trial may receive, aims to strengthen individuals and better prepare them for surgery. Initial findings suggest that exercise can enhance physical function and overall health. However, the certainty of these conclusions varies, and more research is needed to fully understand the impact. Overall, the potential benefits of exercise programs in this setting appear promising. ^{1 6 7 8 9}

Who Is on the Research Team?

Jonathan Singer, MD, MS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

The XFIT trial is for lung transplant candidates experiencing frailty, including those with pulmonary fibrosis. Participants will engage in an 8-week telehealth exercise and behavioral training program from home.

Inclusion Criteria

My physical abilities score is 10 or less.

My physical ability score is 10 or less.

Group 1: Lung Transplant Candidates

Exclusion Criteria

Group 2: Lives Alone

Group 2: BMI < 18.0 kg/m2

I have severe pulmonary hypertension.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week telehealth-delivered exercise and behavioral training program

8 weeks

8 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• XFIT

Trial Overview XFIT aims to test the safety, feasibility, acceptability, and effectiveness of a home-based exercise program designed to improve frailty and physical function in lung transplant candidates.

How Is the Trial Designed?

Group I: XFIT Active Control 1 Intervention

XFIT is an 8-week telehealth-delivered, home-based exercise/behavior modification intervention. It integrates theoretical frameworks of behavior change to engage frail lung transplant candidates in program of pre-habilitation.

Group II: Enhanced standard of care Active Control 1 Intervention

Participants in ESC will be provided with individualized recommendations to improve physical frailty tailored to their baseline assessments, as well as contemporary information on treatments for physical frailty published by the NIH's Science of Frailty group (https://frailtyscience.org/). ESC participants will not engage in weekly treatment sessions, wear activity trackers throughout the intervention period, or receive the personalized psychological treatment provided to those in XFIT.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study involving 300 older adults (average age 82.5 years) with signs of frailty, it was found that greater severity of frailty is linked to lower functional independence and health-related quality of life (HRQoL).

The participants were randomized into a 12-month home-based exercise program or usual care, highlighting the potential for supervised physical activity to improve outcomes for frail individuals, although the results of the intervention are not detailed in this abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older persons with signs of frailty in a home-based physical exercise intervention: baseline characteristics of an RCT. Suikkanen, S., Soukkio, P., Pitkälä, K., et al.[2022]

A 12-week home-based exercise program (HBEP) for patients awaiting liver transplantation was found to be safe and feasible, meeting all study criteria for patient eligibility, recruitment, and adherence.

Participants showed significant improvements in aerobic capacity (measured by the incremental shuttle walk test) and functional capacity after 6 and 12 weeks, suggesting that such exercise programs could benefit patients on the liver transplant waiting list.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Exercise in Patients Awaiting Liver Transplantation: A Feasibility Study. Williams, FR., Vallance, A., Faulkner, T., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06960421

Exercise-based Frailty Intervention in Lung Transplantation ... The goal of XFIT study is to measure the safety of an 8-week telehealth-delivered exercise and behavioral training program to treat frailty in lung transplant ...

2. reporter.nih.gov reporter.nih.gov/project-details/11193900

XFIT: An Exercise-based Frailty Intervention in Lung Transplant ... Over the last decade, our team has shown that physical frailty is present in up to 1/3 of lung transplant candidates and is associated with markedly increased ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06960421

Exercise-based Frailty Intervention in Lung Transplantation ... The goal of XFIT study is to measure the safety of an 8-week telehealth-delivered exercise and behavioral training program to treat frailty ...

4. journals.lww.com journals.lww.com/cptj/fulltext/2025/07000/rehabilitation_for_physical_frailty_in_lung.5.aspx

Rehabilitation for Physical Frailty in Lung Transplant... Exercise training appears beneficial in modifying surrogate markers of physical frailty before LTx, but conclusions are limited by low or very low certainty ...

5. frontierspartnerships.org frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2024.12355/full

Virtual Physical Prehabilitation in Lung Transplant Candidates This study aimed to preliminary test the effectiveness of 12-week virtual physical prehabilitation program followed by a maintenance phase.

6. reporter.nih.gov reporter.nih.gov/search/l-SFCiE4SEWfQo_fF1qDqg/project-details/11193900

An Exercise-based Frailty Intervention in Lung Transplant ... Over the last decade, our team has shown that physical frailty is present in up to 1/3 of lung transplant candidates and is associated with markedly increased ...

7. ucsfhealth.org ucsfhealth.org/clinics/lung-transplant-program

Lung Transplant Program Outcomes data is available from SRTR and from the Organ Procurement and Transplantation Network. ... We conduct additional outreach to candidates for lung ...

8. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/lung-transplant

UCSF Lung Transplant Clinical Trials for 2025 The goal of XFIT study is to measure the safety of an 8-week telehealth-delivered exercise and behavioral training program to treat frailty in ...

9. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/lung-transplant

Lung Transplant clinical trials at University of California Health The goal of XFIT study is to measure the safety of an 8-week telehealth-delivered exercise and behavioral training program to treat frailty in ...