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Progressive Rehabilitation Therapy in Patients With Advanced Lung Disease

NCT03562728 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-03-22

No results posted yet for this study

Summary

The International Society of Heart and Lung Transplantation Registry data shows that there is a growing population of critically ill patients with advanced lung disease undergoing lung transplantation.

The goal of our study is to evaluate the role of intensive physical therapy for patients with advanced lung disease requiring transplant or ECMO(extracorporeal membrane oxygenation)- bridge to transplant with emphasis on the restoration of functional independence and prevention of functional declines after lung transplantation.

The project is a designed as a randomized prospective research study investigating the impact of a multi-modal rehabilitation program(MRP), which incorporates neuromuscular electric stimulation(NMES), strength and mobility training, and nutritional supplementation(NS) in ameliorating the loss of muscle mass and strength, and lower extremity balance, strength and coordination that will decrease time on the ventilator or ECMO, stay in the ICU and hospital.

Conditions

  • Advanced Lung Disease
  • Lung Transplant
  • Extracorporeal Membrane Oxygenation

Interventions

DEVICE

MRP and NMES(neuromuscular electric stimulation)

nutrition supplementation includes addition of essential amino acids 3 times a day to feeding

OTHER

Standard of Care

Patients in the control group are going to receive standard of care

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Irina Timofte · University of Maryland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-13
Primary Completion
2025-11-01
Completion
2027-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03562728 on ClinicalTrials.gov