Ambulation for Frailty in Lung Transplant Patients

(iFRAIL Trial)

Overseen By Marie Budev, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Age <18, Multi-organ transplant, others

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to assess the feasibility and effectiveness of dedicated ambulator-assisted physical activity in lung transplant inpatients. The primary hypothesis is that an ambulator-assisted intervention for lung transplant patients will prove feasible and may result in improved frailty, hospital outcomes, including less need for inpatient rehabilitation and shorter length of stay in the hospital.

Research Team

Marie Budev, DO

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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.

Admitted to the transplant floor (J82) after discharge from the ICU

My medical records include a complete history and physical exam.

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Ambulatory Intervention Experimental Treatment 1 Intervention

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.

Group II: No Ambulator Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+