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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
Complete history and physical examination on file
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-transplant to 1 year following transplant
Awards & highlights

iFRAIL Trial 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.Check my eligibility
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.See study design
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.

iFRAIL Trial 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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My medical records include a complete history and physical exam.
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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.

iFRAIL Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
30-day readmission
Hospital Length of Stay
Regular Nursing Floor Length of Stay
Secondary outcome measures
Accelerometer energy expenditure
Accelerometer step change
Accelerometer time ambulating
+13 more

iFRAIL 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.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,019 Previous Clinical Trials
1,364,875 Total Patients Enrolled
Marie Budev, DOPrincipal InvestigatorThe Cleveland Clinic

Media Library

Ambulation Clinical Trial Eligibility Overview. Trial Name: NCT03636412 — N/A
Transplant Rejection Research Study Groups: Ambulatory Intervention, No Ambulator
Transplant Rejection Clinical Trial 2023: Ambulation Highlights & Side Effects. Trial Name: NCT03636412 — N/A
Ambulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03636412 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals has this clinical trial set out to realize?

"This medical experiment, which will be monitored for one year after transplantation is conducted with the intention of reducing Hospital Length of Stay. Secondary objectives include ascertaining Accelerometer time ambulating (change in movement from pre-transplant to post-transplant), measuring Change in sarcopenia (pre and post-transplant m2) and noting Alterations in step count (difference between pre and post-transplant)."

Answered by AI

Is the recruitment process for this clinical trial still in progress?

"The clinical trial registry registered on clinicaltrials.gov states that this particular medical study is not actively enrolling new individuals. The initial listing for the research was posted August 15th 2018 but has since been updated June 30th 2022. Nevertheless, 280 other studies are currently seeking patients to participate in their own trials."

Answered by AI
~3 spots leftby Apr 2024