Ignite Creation Date:
2024-05-06 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03562728
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2018-05-23
Brief Title:
Progressive Rehabilitation Therapy in Patients With Advanced Lung Disease
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Assessing the Functional Impact of Progressive Rehabilitation Therapy in Patients With Advanced Lung Disease Requiring Lung Transplantation or ECMO- Bridge to Transplant
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ECMOextracorporeal 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 programMRP which incorporates neuromuscular electric stimulationNMES strength and mobility training and nutritional supplementationNS 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
The goal of our study is to evaluate the role of intensive physical therapy for patients with advanced lung disease requiring transplant or ECMOextracorporeal 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 programMRP which incorporates neuromuscular electric stimulationNMES strength and mobility training and nutritional supplementationNS 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
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 patients clinical status
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 patients clinical status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None