Development of a Rehabilitation Strengthening and Mobility Program for Ventilator Dependent Older Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Functional Assessment: 6 Minute Walk Distance
研究概览
简要总结
As the general population ages and technology advances, many who suffer from catastrophic critical illness (i.e. septic shock, respiratory failure, Acute Respiratory Disease Syndrome) survive only to find themselves severely physically debilitated and compromised from a pulmonary standpoint, requiring assistance from a mechanical ventilator in order to breath. Oftentimes, these patients require a long course of physical rehabilitation and ventilator support. These patients frequently remain ventilator dependent for greater than 3 weeks, and are thus referred to as requiring prolonged mechanical ventilation (PMV).
Older patients are at significantly higher risk for requiring PMV for reasons that are not entirely clear, but which may include physical deconditioning, impaired cardiopulmonary physiology, and cognitive or behavioral disturbances.
The purpose of this study is two fold: 1. to characterize the functional phenotype of ventilator dependent, and recently ventilated patients with respect to general strength, endurance, balance, and pulmonary functioning and body composition. 2. To pilot test a rehabilitation protocol that targets improving this populations disabilities through exercises focused on improving strength, endurance, balance, and pulmonary functioning.
详细描述
Screening will occur daily, at which time the subject's medical history and current condition will be reviewed. If they qualify informed consent will be obtained and the subject will undergo baseline tests of function and health.
The subject will be asked to perform simple tasks for baseline testing purposes. These include timed walking, lifting light weights or elastic exercise bands, assessment of handgrip strength, getting up out of a chair, breathing into a machine to test lung function, and answering questionnaires. The order of these tests may vary depending upon the subject's schedule and availability of equipment. It may be necessary to repeat one or more of the tests. Not all tests will be performed on everyone, depending upon one's strength, balance, coordination and endurance.
After the completion of the baseline tests subjects will be randomized into one of two groups. One group will receive a multimodal rehabilitation program (MRP) and usual care and the other will receive usual care physical therapy.
If the subject is randomized to the intervention group, he/she will receive special MRP sessions three times a week, for up to 8 weeks. Each session will last approximately one hour, and will consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. All sessions will be supervised by a licensed physical therapist, physical trainer, or certified instructor, with a respiratory therapist present, if needed. Sessions will be conducted at the Pulmonary Rehabilitation Gymnasium at the University of Maryland, Midtown Campus (MTC) or in the subjects room at bedside.
If the subject is not randomized to the group receiving the MRP, they will receive the standard therapy program provided by MTC therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 or greater
- •Received prolonged mechanical ventilation for >= 14 days during their last acute hospitalization
- •Has received mechanical ventilation within the past 14 days for at least 6 hours in a 24 hour period
- •Tracheostomy in place
- •Subject is able to follow commands, and can give written or witnessed verbal consent in English
- •Subject is eligible for physical rehabilitation
- •All four limbs intact and mobile
排除标准
- •Acute superimposed cardiopulmonary disease (ie.pulmonary edema, Stage IV congestive heart failure, COPD exacerbation, asthma attack, untreated infections, other)
- •Severe functional impairment or physical impairment to rehabilitation
- •Dementia, cognitive impairment (see attached description outlining cognitive impairment under additional documents)
研究组 & 干预措施
Usual care
Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
multimodal physical therapy
Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills.
干预措施: multimodal physical therapy (Other)
结局指标
主要结局
Functional Assessment: 6 Minute Walk Distance
时间窗: Upon completion of study, up to 56 days
6 minute walk distance will be reported in feet
Functional Assessment: Handgrip
时间窗: Upon completing of study, up to 56 days
Handgrip strength will be reported in kilograms
Functional Assessment: Short Physical Performance Battery (SPPB)
时间窗: Upon Completion of study, up to 56 days
Short Physical Performance Battery will be reported as a score from 0 to 12 from with lower scores indicating a worse outcome
Functional Assessment: 4 Meter Gait Speed
时间窗: Upon completion of study, up to 56 days
4 meter gait speed will be reported in meters per second
次要结局
- Percent of Patients Weaned From Mechanical Ventilation(Upon completion of study, up to 56 days)
- Percent of Patients Discharged Home(Upon completion of study, up to 56 days)
研究者
Avelino Verceles
Associate Professor
University of Maryland, Baltimore