跳至主要内容
临床试验/NCT02421692
NCT02421692终止不适用

Improving Physical Function in Skilled Nursing Facility Residents

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2015年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
153
试验地点
1
主要终点
Short Physical Performance Battery (SPPB)

研究概览

简要总结

Each year Medicare spends approximately $31.3 billion on 2.4 million skilled nursing facility (SNF) episodes of care. SNFs rely on interdisciplinary approaches to patient care to maximize rehabilitation potential for return to prior level of function and reduce the risk of adverse events in older adults. However despite a substantial increase in spending on SNF services and minimal change in complexity of the caseload, 68% of patients are below their pre-hospitalization level of function at discharge, 25% return to the community, and 18% are hospitalized. This may be partially explained by current SNF approaches to patient care which foster inactivity and participation in low intensity rehabilitation interventions (preliminary data). Both inactivity and low-intensity interventions may perpetuate further functional decline or impede maximal recovery. The serious implication of risk with functional decline is exemplified by studies which have shown declines in physical function can increase the risk of being re-hospitalized six-fold and may infer other long term effects such as increased risk for mortality, morbidity, and institutionalization. Muscle weakness, reduced cardiorespiratory reserve, and neuromuscular deficits have been attributed to this acute decline in function. However current rehabilitation strategies in SNFs do not promote adequate dose and mode of interventions to induce beneficial systemic adaptations, perhaps due to the lack of evidence on effective rehabilitation protocols for this medically-complex population. Therefore, the investigators have designed an rehabilitation program, which uniquely integrates principles of physiologic tissue overload with strengthening and functional interventions for greater gains in physical function. Data will be collected on the first cohort of patients who cycle through a SNF during Stage 1, in which usual care occurs (5 months). Then, staff training on progressive rehabilitation interventions will occur over 2 months. Finally, data will be collected on a second cohort of patients who cycle through a SNF during Stage 2, in which progressive rehabilitation is implemented by SNF staff (5 months). Given the high turnover of patients in SNFs (average length of stay ~21 days), 2 different cohorts of patients will be studied and the analysis will consist of independent 2-sample t-tests. During Stage 1 and 2, measures of physical function will be assessed on all eligible patients at admission and discharge from SNF. Therapists will be assessed on adherence to the protocol through documentation audits and use of on-site observational checklist. Acceptability of the intervention by the patients will be assessed by a patient satisfaction survey. Any adverse events will be obtained from the medical record and documented. The discharge location of all patients will be documented.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults older ≥55 years of age who are admitted to a skilled nursing facility following hospitalization
  • •Qualify to receive at least physical therapy services.

排除标准

  • •Patients with primary diagnoses related to neurological disorders will be excluded as patient needs require more of a motor-control approach versus the proposed high-intensity approach. Such patient populations include:
  • •Parkinson's Disease
  • •Traumatic Brain Injury
  • •Recent Cerebral Vascular Accident
  • •Alzheimer's
  • •Patients on hospice care will be excluded as the approach is based on palliative principles. Other patients to be excluded will include those with conditions where strength training is contraindicated (as indicated by the American College of Sports Medicine Guidelines for Exercise Testing and Prescription):
  • •Recent unstable fractures
  • •Advanced congestive heart failure (ejection fracture <30%)
  • •Bone metastasis sites
  • •Tumors in strengthening target areas
  • •Acute illness
  • •Recent myocardial infarction (within 3-6 weeks)
  • •Weight bearing restrictions on graft or fracture sites
  • •Exposed tendon or muscle
  • •Absence of pedal pulses
  • •Presence of a fistula
  • •Platelet levels <50,000/µL.
  • •Additional exclusions assessed prior to randomization include a score of less than 21 on the Mini-Mental Status Exam.

研究组 & 干预措施

Usual Care

No Intervention

SNF rehabilitation therapists provide all patients with usual standard of care.

Progressive Rehabilitation

Experimental

SNF rehabilitation therapists have been trained on principles of progressive rehabilitation strategies and will implement to all eligible patients as new standard of care.

干预措施: Progressive Rehabilitation (Other)

结局指标

主要结局

Short Physical Performance Battery (SPPB)

时间窗: Change from Admission to Discharge (expected average length of stay 21 days)

Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests

次要结局

  • Gait Speed(Change from Admission to Discharge (expected average length of stay 21 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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