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临床试验/NCT03562728
NCT03562728进行中(未招募)不适用

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

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
70
试验地点
2
主要终点
Global muscle strength

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Global muscle strength

时间窗: 14 days

Muscle group strength is obtained using hand held dynamometer

Muscle mass

时间窗: 14 days,

Muscle mass measurement of lower extremity muscle volume using ultrasound scan or computer tomography

Mobility status

时间窗: 14 days

Mobility status is assessed with 6 minute walk distance

次要结局

  • Time on the ventilator or ECMO(14 days, 1 month)
  • Stay in the ICU and hospital(14 days, 1,3month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Irina Timofte

Assistant Professor

University of Maryland, Baltimore

研究点 (2)

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