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Active, Not Recruiting

NCT Number: NCT03562728

Progressive Rehabilitation Therapy in Patients With Advanced Lung Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRP and NMES(neuromuscular electric stimulation)

Device

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

Other names: Dietary Supplement(NS)

Standard of care

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Assessing the Functional Impact of Progressive Rehabilitation Therapy in Patients With Advanced Lung Disease Requiring Lung Transplantation or ECMO- Bridge to Transplant

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Jun 19, 2018
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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