Exercise Program for Frailty in Lung Transplant Candidates

(XFIT Trial)

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

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

What data supports the effectiveness of the treatment XFIT for frailty in lung transplant candidates?

Research shows that home-based exercise programs can improve physical capacity and quality of life in patients awaiting liver transplants, and mobile health technology has been effective in improving frailty and physical activity in lung transplant recipients. These findings suggest that similar exercise interventions like XFIT could be beneficial for lung transplant candidates. ^{1 2 3 4 5}

Is the exercise program safe for frail patients awaiting organ transplants?

A 12-week home-based exercise program, including resistance and aerobic exercises, was found to be safe for patients awaiting liver transplants, with no serious adverse events reported. ^{1 2 4 5 6}

How does the XFIT treatment for frailty in lung transplant candidates differ from other treatments?

XFIT is unique because it focuses on a structured exercise program specifically designed for lung transplant candidates to address frailty, which is not commonly targeted by standard treatments. This approach emphasizes improving exercise capacity and physical function, which are crucial for better transplant outcomes. ^{1 2 3 7 8}

What is the purpose of this trial?

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 candidates in their own home. The main questions XFIT aims to answer are: * Is XFIT safe? * Is XFIT feasible and acceptable by participants? * Is XFIT effective in improving frailty and physical function as reflected in patient-reported outcomes. Participants will: - Participate in the 8-week XFIT program or enhanced standard of care

Research Team

Jonathan Singer, MD, MS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Frailty and maximal exercise capacity in adult lung transplant candidates. [2018]

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

Home-Based Exercise in Patients Awaiting Liver Transplantation: A Feasibility Study. [2021]

3. Denmark pubmed.ncbi.nlm.nih.gov

Mobile health technology to improve emergent frailty after lung transplantation. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Older persons with signs of frailty in a home-based physical exercise intervention: baseline characteristics of an RCT. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

A mobile health technology enabled home-based intervention to treat frailty in adult lung transplant candidates: A pilot study. [2019]

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

Frailty trajectories in adult lung transplantation: A cohort study. [2020]

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

Relationship of Exercise Capacity, Physical Function, and Frailty Measures With Clinical Outcomes and Healthcare Utilization in Lung Transplantation: A Scoping Review. [2022]

8. Denmark pubmed.ncbi.nlm.nih.gov

Pre-transplant short physical performance battery: Response to pre-habilitation and relationship to pre- and early post-lung-transplant outcomes. [2021]