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Ambulation for Frailty in Lung Transplant Patients (iFRAIL Trial)

N/A

Waitlist Available

Led By Marie Budev, DO

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have undergone a single or bilateral lung transplant

Able to ambulate pre-transplant (not bed/wheelchair bound) with or without assistive device

Must not have

Admitted to hospital for expedited transplant work-up

Current invasive mechanical ventilation or placement of ECMO cannula

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-transplant to 1 year following transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a physical activity intervention is feasible and effective for improving outcomes in lung transplant patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves physical activity assisted by an ambulator (a device or person), potential side effects may include muscle soreness, fatigue, joint pain or discomfort related to increased activity levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a lung transplant.

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I can walk by myself or with help from a device.

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I am on the waiting list for a lung transplant.

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I have a physical therapy consult and scored ≥6 on the JH-HLM Scale after moving to the transplant floor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am in the hospital for a fast-track transplant evaluation.

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I am currently on a ventilator or have an ECMO cannula in place.

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I have had a multi-organ transplant (like liver-lung or heart-lung).

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I need a machine to help me breathe during the day or night.

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I am under 18 years old.

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I was hospitalized before my transplant date.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-transplant to 1 year following transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-transplant to 1 year following transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-transplant to 1 year following transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

30-day readmission

Hospital Length of Stay

Regular Nursing Floor Length of Stay

Secondary study objectives

Accelerometer energy expenditure

Accelerometer step change

Accelerometer time ambulating

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ambulatory InterventionExperimental Treatment1 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 AmbulatorActive Control1 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.

0 / 10Eligibility criteria met