Ambulation for Frailty in Lung Transplant Patients
(iFRAIL Trial)
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Transplant Assessment
Evaluation of frailty and physical performance before lung transplant
Post-Transplant Treatment
Ambulator-assisted physical activity intervention and standard physical therapy
Follow-up
Participants are monitored for safety, effectiveness, and frailty changes after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
Patients who score greater than or equal to 6 on the John's Hopkins Highest Level of Mobility (JH-HLM) scale, up to 72 hours after transfer from the ICU to the regular nursing floor will be enrolled in an ambulatory intervention. Care technicians will ambulate patients three times per day at their level of physical ability. They will also receive physical therapy standard of care.
Patients who score less than 6 on the John's Hopkins Highest Level of Mobility (JH-HLM) scale, up to 72 hours after transfer from the ICU to the regular nursing floor will not be enrolled in the ambulatory intervention. They will receive physical therapy standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
Citations
Rehabilitation for Physical Frailty in Lung Transplant Candidates
The 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.
3.
frontierspartnerships.org
frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2024.12355/fullVirtual 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.
4.
journals.lww.com
journals.lww.com/transplantationdirect/fulltext/2020/03000/remote_therapy_to_improve_outcomes_in_lung.6.aspxRemote 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 TEXT
Our results indicated that the comprehensive PR led to improvement in functional mobility; that is, patients demonstrated an increased muscle ...
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