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临床试验/NCT05906446
NCT05906446已完成不适用

Feasibility of a Multicomponent Frailty Intervention During Post-acute Rehabilitation in Skilled Nursing Facilities

Hebrew SeniorLife2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Feasibility of the Intervention

研究概览

简要总结

The goal is to test feasibility of a frailty intervention, including exercises and nutritional supplementation.

详细描述

The frailty intervention includes frequent short exercise sessions incorporating balance, resistance training, and walking to accommodate diminished endurance, with synergistic protein and nutritional supplementation, delivered on top of usual care in the post-acute Skilled Nursing Facility (SNF) setting. There is no control group.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Community-dwelling before hospitalization
  • Age ≥ 65 years
  • Admitted to SNF directly from inpatient hospitalization
  • English speaking
  • Mild Frailty or worse, as measured by a Clinical Frailty Scale

排除标准

  • Discharged from Emergency Department
  • Non-community discharge plan on admission (e.g. plan to discharge to hospice)
  • Nothing per oral (NPO) dietary status
  • Presence of any feeding tube
  • Chronic kidney disease stage IV or worse
  • Clinician refusal
  • Inability or refusal to consume intervention products (e.g. allergies to protein supplement)
  • Inability to consent to study procedures

结局指标

主要结局

Feasibility of the Intervention

时间窗: Estimated average <1 month

Feasibility will be determined by assessing 1) the proportion of eligible patients enrolled, and 2) the proportion of participants adherent to the intervention Range: 0-100% (higher values indicate higher feasibility).

Feasibility of the Intervention

时间窗: Estimated average <1 month

Feasibility will be determined by assessing 1) the proportion of eligible patients enrolled, and 2) the proportion of participants adherent to the intervention Range: 0-100% (higher values indicate higher feasibility).

次要结局

  • Gait Speed(Discharge (on average between 2-3 weeks))
  • Adherence to supplementation(Entire study period (on average over 2-3 weeks))
  • Grip Strength(Discharge (on average at 2-3 weeks))
  • The Patient Reported Outcomes Measurement Information System (PROMIS Global Health v1.2)(Discharge (on average at 2-3 weeks))
  • Modified Barthel Index(Discharge (on average at 2-3 weeks))
  • Adherence to exercise(Entire study period (on average over 2-3 weeks))
  • Adherence to supplementation(Entire study period (on average over 2-3 weeks))
  • Gait Speed(Discharge (on average between 2-3 weeks))
  • Grip Strength(Discharge (on average at 2-3 weeks))
  • The Patient Reported Outcomes Measurement Information System (PROMIS Global Health v1.2)(Discharge (on average at 2-3 weeks))
  • Modified Barthel Index(Discharge (on average at 2-3 weeks))
  • Adherence to exercise(Entire study period (on average over 2-3 weeks))

研究者

发起方
Hebrew SeniorLife
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Shi

Instructor of Medicine

Hebrew SeniorLife

研究点 (2)

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