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Trial record 7 of 13 for:    24108501 [PUBMED-IDS]

Progressive Rehabilitation Therapy in Patients With Advanced Lung Disease

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ClinicalTrials.gov Identifier: NCT03562728
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Irina Timofte, University of Maryland, College Park

Brief 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.


Condition or disease Intervention/treatment Phase
Advanced Lung Disease Lung Transplant Extracorporeal Membrane Oxygenation Device: MRP and NMES(neuromuscular electric stimulation) Other: Standard of Care Not Applicable

Detailed Description:

Intensive rehabilitation is recognized as an essential component to successful outcomes for post procedure recovery after a major cardio-thoracic procedure. The investigators propose a unique multi-modal rehabilitation program (MRP) that combines a step-up physical therapy protocol with neuromuscular electric stimulation (NMES), nutritional supplementation (NS), occupational therapy and pulmonary rehabilitation techniques to achieve improved functional outcomes for advanced lung disease patients requiring transplantation or ECMO-bridge to transplant. The investigators hypothesized that a progressive rehabilitation program, incorporating neuromuscular electric stimulation, strength and balance training, and nutritional supplementation with essential amino acids will reduce sarcopenia and loss of functional mobility in patients with advanced lung disease requiring transplantation or ECMO-bridge to transplant.

The purpose of this study is to determine the effectiveness of a progressive rehabilitation program, which incorporates neuromuscular electric stimulation, strength and mobility training, and nutritional supplementation in ameliorating 1) the loss of muscle mass and strength, and lower extremity balance, strength and coordination, 2) time on the ventilator or ECMO, stay in the intense care unit and hospital, and 3) return home and quality of life compared to usual ICU care.

The investigators propose a prospective, randomized interventional trial assessing the effectiveness of the program in decreasing adverse post-transplant outcomes compared to usual care. All advanced lung disease patients listed for transplantation or requiring ECMO cannulation will be screened for this study according to the inclusion and exclusion criterion. The patients will be randomized to either the treatment arm or usual care within 72 hours after the procedure (transplant or ECMO cannulation if patient requires ECMO-bridge to transplant). All groups of patients will undergo an initial global assessment of functional capabilities after listing for lung transplantation and then again within 72 hours after cardio-thoracic procedure (transplant or ECMO cannulation). Patients in the treatment arm will receive additional physical therapy that include: arm and leg exercises, using light weight machines, hand weights, or rubber bands, exercise machines such as portable arm or seated bikes. The treatment group will receive exercise therapy plus therapy with an electric stimulator device. This device uses weak electric impulses to involuntarily exercise the muscles (one-two sessions a day, with each session starting off at 10 minutes, then increasing to a maximum of 30 minutes). Subjects receiving the intervention will receive daily treatment using the neuromuscular electric stimulation unit. Four muscle groups (quadriceps and dorsiflexors bilaterally) will be stimulated using 3x5 inch surface electrodes (quadriceps) and 2x4 inch (dorsiflexors). In addition, patients in the experimental group will receive nutrition supplementation with essential amino acids 3 times a day in their feeding to prevent muscle breakdown and promote positive nitrogen balance. Comprehensive re-assessments are repeated on a weekly basis and the therapy will be adjusted to the patient's clinical status.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessing the Functional Impact of Progressive Rehabilitation Therapy in Patients With Advanced Lung Disease Requiring Lung Transplantation or ECMO- Bridge to Transplant
Actual Study Start Date : January 13, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ECMO- Bridge to Transplant
Interventions: MRP+MNES(neuromuscular electric stimulation).Patients in the treatment arm will receive additional physical therapy(arm and leg exercises, using light weight machines, hand weights, or rubber bands, exercise machines such as portable arm or seated bikes) as well as therapy with an electric stimulator device. This device uses weak electric impulses to involuntarily exercise the muscles(one-two sessions a day).Four muscle groups(quadriceps and dorsiflexors bilaterally) will be stimulated using surface electrodes .In addition, patients in the experimental group will receive nutrition supplementation with essential amino acids 3 times a day in their feeding to prevent muscle breakdown and promote positive nitrogen balance.
Device: MRP and NMES(neuromuscular electric stimulation)
nutrition supplementation includes addition of essential amino acids 3 times a day to feeding
Other Name: Dietary Supplement(NS)

ECMO- Bridge to Transplant Control Group

Interventions: standard of care

Patients are not going to receive any additional intervention.

Other: Standard of Care
Patients in the control group are going to receive standard of care

Active Comparator: Transplant
Interventions: MRP+MNES(neuromuscular electric stimulation).Patients in the treatment arm will receive additional physical therapy(arm and leg exercises, using light weight machines, hand weights, or rubber bands, exercise machines such as portable arm or seated bikes) as well as therapy with an electric stimulator device. This device uses weak electric impulses to involuntarily exercise the muscles(one-two sessions a day).Four muscle groups(quadriceps and dorsiflexors bilaterally) will be stimulated using surface electrodes .In addition, patients in the experimental group will receive nutrition supplementation with essential amino acids 3 times a day in their feeding to prevent muscle breakdown and promote positive nitrogen balance.
Device: MRP and NMES(neuromuscular electric stimulation)
nutrition supplementation includes addition of essential amino acids 3 times a day to feeding
Other Name: Dietary Supplement(NS)

Transplant Control Group

Interventions: standard of care.

Patients are not going to receive any additional intervention.

Other: Standard of Care
Patients in the control group are going to receive standard of care




Primary Outcome Measures :
  1. Global muscle strength [ Time Frame: 14 days ]
    Muscle group strength is obtained using hand held dynamometer

  2. Mobility status [ Time Frame: 14 days ]
    Mobility status is assessed with 6 minute walk distance

  3. Muscle mass [ Time Frame: 14 days, ]
    Muscle mass measurement of lower extremity muscle volume using ultrasound scan or computer tomography


Secondary Outcome Measures :
  1. Time on the ventilator or ECMO [ Time Frame: 14 days, 1 month ]
    Measured as ECMO or ventilator days

  2. Stay in the ICU and hospital [ Time Frame: 14 days, 1,3month ]
    Measured as days in the ICU and hospital



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced lung disease requiring lung transplantation
  • Advanced lung disease requiring ECMO bridge to lung transplantation
  • Patient or legally authorized representative are able to provide written or witnessed verbal consent.

Exclusion Criteria:

  • Unable to obtain consent from patient or family member
  • Advanced lung disease but not transplant candidate due to other comorbidities
  • Patient is deemed unsafe for rehabilitation by the transplant physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562728


Contacts
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Contact: Irina Timofte, MD 410 328 2864 irtimofte@SOM.umaryland.edu
Contact: Avelino Verceles, MD 410-328-8141 avercele@som.umaryland.edu

Locations
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United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Irina o Timofte    410-328-2864 ext 4103282864    Irtimofte@som.umaryland.edu   
Contact: Irina o Timofte    4103282864 ext 4103282864    Irtimofte@som.umaryland.edu   
Sponsors and Collaborators
University of Maryland, College Park
Investigators
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Principal Investigator: Irina Timofte University of Maryland, College Park

Publications:

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Responsible Party: Irina Timofte, Assistant Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT03562728     History of Changes
Other Study ID Numbers: HP-00080970
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information will be shared only with the investigators that are actively involved in the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Irina Timofte, University of Maryland, College Park:
Transplant
ECMO
Sarcopenia
Deconditioning
Physical therapy
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases