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临床试验/NCT03704194
NCT03704194已完成不适用

Adapted Lifestyle-integrated Functional Exercise Program for Older Adults in Under Resourced Communities: A Pilot Study

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年8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
17
试验地点
2
主要终点
The Berg Balance Scale (BBS)

研究概览

简要总结

This study will test the feasibility of a study design for the Adapted Lifestyle-integrated Functional Exercise (LiFE) program for medically underserved older adults and to explore factors related to implementation. A feasibility trial will be conducted with a total of 16 participants. The control group will receive flexibility exercise program as attention control.

详细描述

This study will test the feasibility the Adapted Lifestyle-integrated Functional Exercise (LiFE) program among medically underserved older adults. Sixteen medically underserved older adults will be recruited in the study and randomized to Adapted LiFE or attention control group (flexibility exercise program). Process outcomes and preliminary outcomes will be collected to determine feasibility and preliminary efficacy. Process outcomes such as reach, acceptance, adherence, fidelity, and safety will also be collected throughout the study. Preliminary efficacy outcomes include habit formation, balance, muscle strength will be collected at baseline and at immediately after intervention is completed.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • (1) age 70 or older;
  • (2) live independently;
  • (3) live in a medically underserved/health professional shortage area;
  • (4) self-report two falls or one injurious fall.

排除标准

  • (1) Short Blessed Test score ≥8, indicating cognitive impairment consistent with dementia;
  • (2) inability to stand independently with a walking device;
  • (3) having a serious health condition with a physician's order where exercise is contraindicated.

结局指标

主要结局

The Berg Balance Scale (BBS)

时间窗: Baseline and 12 weeks

The Berg Balance Scale (BBS) is a 14-item assessment of static and dynamic balance. Performance quality, time, and assistance required are rated on a scale of 0-4 based on pre-specified criteria. Total scores range from 0-56, with a score of 45 or below indicating high risk of falls.

次要结局

  • The Short Physical Performance Battery (SPPB)(Baseline and 12 weeks)
  • The Activities-specific Balance Confidence Scale (ABC)(12 weeks)
  • Center of Pressure (CoP) Velocity (cm/s)(Baseline and 12 weeks)
  • Center of Pressure (CoP) Path (cm)(Baseline and 12 weeks)
  • The Self-Reported Habit Index (SRHI)(Baseline and 12 weeks)
  • Lower Extremity Muscle Strength(Baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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