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临床试验/NCT04814459
NCT04814459已完成不适用

Prevention Focused Home-Based Physical Therapy Utilizing Community Partnership Referrals

Oakland University2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
144
试验地点
2
主要终点
Stopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk Categorization

研究概览

简要总结

This novel study supports the positive benefits of Home Based Older Persons Upstreaming Physical Therapy (HOP-UP-PT) to older adults identified as "at-risk" by their local senior center after participating in a prevention-focused multimodal program provided by physical therapists in their home.

详细描述

The purpose of this study was to describe the outcomes of Home Based Older Persons Upstreaming Physical Therapy (HOP-UP-PT) program participants and then to compare these outcomes to non-participants. 144 participants (n=72 per group) will be randomized to either the HOP-UP-PT intervention group or the Normal level of activity group. Six Michigan senior centers will refer adults ≥ 65 years who were at-risk for functional decline or falls. Licensed physical therapists will deliver physical, environmental, and health interventions within their approved scope of practice to the HOP-UP-PT intervention group during nine encounters (six in-person, three telerehabilitation) delivered over seven months. The Normal level of activity group participants are told to continue their usual physical activity routines during the same timeframe. Baseline and re-assessments are conducted at 0-, 3-, and 7-months for both the HOP-UP-PT intervention group and Normal level of activity group. Descriptions and comparisons from each assessment encounter will be analyzed.

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

入选标准

  • Greater than or equal to 65 years of age
  • Senior Community Center staff identified them as 'at-risk' for decline in community dwelling status due to physical, social, economic, or community-related barriers
  • Willingness to participate

排除标准

  • Received physical therapy services within the prior two months in any setting
  • Had been hospitalized within the prior two months
  • Were currently receiving palliative or hospice care
  • Mini Cog score less than 4 and Trail Making Part B score greater than 273 seconds
  • Outcomes American College of Sports Medicine exercise pre-participation health screening indicating physician clearance needed for participation and after evaluation the physician will not clear

结局指标

主要结局

Stopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk Categorization

时间窗: 7 Months

Low, moderate, and high risk was determined relative to results of the stay independent brochure, subjective report of falls and fall risk and brochure questions, as well as gait, strength, and balance assessment. The Stopping Elderly Accidents, Death \& Injuries (STEADI) Algorithm underwent revisions since the study onset, the 2015 version was utilized as a guide for key outcome metrics reported in this study. Low STEADI risk =0, moderate STEADI risk =1, and high STEADI risk = 2. Low risk participants were categorized based on "no" responses to falls or fall risk questions as well as no gait, strength, or balance problems. Moderate risk participants were categorized by answering "yes" to key questions as well as demonstrating some gait, strength, or balance problems, and had a fall without injury. High risk participants were categorized by answering yes to key questions, demonstrating gait, strength, or balance problems, and had 2 or more falls or 1 fall with an injury.

Timed Up and Go

时间窗: 7 Months

The Timed Up and Go (TUG) is a times assessment of sit to stand transfer, 20 foot bought of ambulation with a 180 degree turn at 10 feet concluding with a stand to sit transfer.

Number of Participants With Reported Falls

时间窗: 7 months

Record of falls in prior year, and between each subsequent visit.

Modified Short Physical Performance Battery (SPPB)

时间窗: 7 Months

The Modified SPPB uses a 0-12 scale (0 = lowest function, 12 = highest function), calculated using collective outcomes of The Four Test Balance Scale (0= unable to perform, 1 = able to stand: feet together \>10 sec, 2 = semi-tandem \>10 sec, 4 = tandem stance \>10 sec, higher score is better balance), 5 Time Sit to Stand (0 = \>60 sec, 1=16.7 to 60 sec, 2 = 13.7 to 16.69 sec, 3 = 11.2 to 13.69 sec, and 4 = \<11.19 sec, faster time is higher function), and the 3-meter gait speed test (0 = unable to perform, 1= \> 6.52 sec, 2 = 4.66 to 6.52 sec, 3 = 3.62 to 4.65 sec, and 4 = \< 3.62 sec, faster time is higher function). Each of the three categories has a highest score of 4 and are summed together for a highest total Modified SPPB score of 12.

次要结局

  • Modified Falls Efficacy Scale(3 Months)
  • Health Behavior Questionnaire(3 Months)
  • Functional Comorbidity Index(7 Months)
  • Stay Independent Questionnaire(3 Months)
  • Body Mass Index(7 Months)
  • Number of Participants With Orthostatic Hypotension(7 months)
  • Blood Pressure(7 Months)
  • Home Falls and Accidents Screening Tool (Home FAST)(7 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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