Progressive Rehabilitation Therapy in Patients With Advanced Lung Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/3/2019 |
| Start Date: | January 13, 2019 |
| End Date: | September 1, 2020 |
| Contact: | Irina Timofte, MD |
| Email: | irtimofte@SOM.umaryland.edu |
| Phone: | 410 328 2864 |
Assessing the Functional Impact of Progressive Rehabilitation Therapy in Patients With Advanced Lung Disease Requiring Lung Transplantation or ECMO- Bridge to Transplant
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.
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.
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.
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.
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
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