Ambulation for Frailty in Lung Transplant Patients

(iFRAIL Trial)

BS
MB
Overseen ByMarie Budev, DO
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether assisted walking (ambulation) can help lung transplant patients recover faster and improve their overall health during hospitalization. The goal is to determine if this approach can reduce hospital stays and lessen the need for rehabilitation. Eligible participants must have undergone a lung transplant and be able to walk, even with some assistance. As an unphased trial, this study allows patients to contribute to innovative research that could enhance recovery strategies for future lung transplant recipients.

Do I need to stop my current medications for this trial?

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 this ambulation protocol is safe for lung transplant patients?

Research shows that early mobility, such as walking, is generally safe for lung transplant patients. Studies have found that this practice can enhance their mobility with minimal risk. Early movement often results in stronger muscles and improved overall function.

Importantly, there have been no major reports of complications from this activity. Patients typically tolerate walking well, allowing them to move safely with supervision. The goal is to aid lung transplant patients in recovering faster and more effectively.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on ambulation, or walking, as a novel approach to help frail lung transplant patients improve their mobility. Unlike standard physical therapy, which typically involves exercises performed in a stationary position, this method involves patients actively walking with assistance. This approach may enhance recovery by building strength and endurance, potentially leading to better post-transplant outcomes. The trial aims to find out if this proactive, movement-based technique can make a difference in the recovery process compared to traditional methods.

What evidence suggests that ambulation is effective for improving frailty in lung transplant patients?

This trial will compare an ambulatory intervention with no intervention for lung transplant patients. Research has shown that assisted walking can reduce frailty in these patients. One study found that exercise programs made lung transplant candidates stronger and more active. Another study found that lung transplant patients who stayed active experienced better recovery outcomes. These findings suggest that walking could enhance recovery and shorten hospital stays for lung transplant patients.15678

Who Is on the Research Team?

MB

Marie Budev, DO

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults on the lung transplant waiting list who can walk with or without help and are not bed/wheelchair-bound. They must understand the study, speak English, be admitted to a specific hospital floor post-ICU, and have a certain score on a frailty scale. It's not for those under 18, in urgent work-up for transplant, already hospitalized before transplant day, needing mechanical breathing support or multi-organ transplants.

Inclusion Criteria

I have had a lung transplant.
My medical records include a complete history and physical exam.
Admitted to the transplant floor (J82) after discharge from the ICU
See 5 more

Exclusion Criteria

I am currently on a ventilator or have an ECMO cannula in place.
I have had a multi-organ transplant (like liver-lung or heart-lung).
Bed rest order placed
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Transplant Assessment

Evaluation of frailty and physical performance before lung transplant

Weeks to a year

Post-Transplant Treatment

Ambulator-assisted physical activity intervention and standard physical therapy

Up to 1 year
Multiple daily ambulation sessions

Follow-up

Participants are monitored for safety, effectiveness, and frailty changes after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Ambulation
Trial Overview The study tests if helping lung transplant patients walk (ambulation) after surgery helps them recover better. The goal is to see if this assistance leads to less need for rehab and shorter hospital stays by improving their physical condition.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Ambulatory InterventionExperimental Treatment1 Intervention
Group II: No AmbulatorActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

Citations

Rehabilitation for Physical Frailty in Lung Transplant CandidatesThe objectives of this study were to systematically evaluate the effectiveness of exercise (intervention) in modifying physical frailty (outcome) ...
Ambulation for Frailty in Lung Transplant Patients (iFRAIL ...The objective of this study is to assess the feasibility and effectiveness of dedicated ambulator-assisted physical activity in lung transplant inpatients.
Virtual Physical Prehabilitation in Lung Transplant CandidatesThis study aimed to preliminary test the effectiveness of 12-week virtual physical prehabilitation program followed by a maintenance phase.
Remote Therapy to Improve Outcomes in Lung Transplant...Lung transplant recipients exhibit a slower return to normal psychological functioning compared with other solid organ transplant recipients, 42 and, ...
Improving Lung Transplant Outcomes with Coping Skills ...The study will aim to evaluate the effectiveness of the Coping Skills Training plus Exercise (CSTEX) intervention in reducing distress.
Early mobilization after lung transplantation: A scoping ...The main question is: what evidence exists regarding the feasibility, safety, and clinical outcomes of early mobilization interventions for lung transplant ...
Early mobilization after lung transplantation: A scoping review ...The main question is: what evidence exists regarding the feasibility, safety, and clinical outcomes of early mobilization interventions for LTx ...
FULL TEXTOur results indicated that the comprehensive PR led to improvement in functional mobility; that is, patients demonstrated an increased muscle ...
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