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临床试验/NCT03709251
NCT03709251终止不适用

High Intensity Walking to Reduce Frailty

Northwestern University2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2018年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
59
试验地点
2
主要终点
Change in frailty as measured by the Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI)

研究概览

简要总结

The purpose of this study is to evaluate a physical therapist (PT) led gait training intervention for 100 older adults with pre-frailty or frailty. The goals of this study are To determine the effect of gait training intensity on frailty, mobility, physical functioning, and quality of life, as well as balance and healthcare utilization.

详细描述

Frailty is a leading cause of dependency among older adults, affects up to 60% of older adults, and is associated with an increased risk for falls, hospitalizations, institutionalization, and death. Exercise is the most widely recommended treatment for improving physical function among the frailty, but the optimal type or intensity of exercise is unknown. Walking is a preferred physical activity among older adults, however, there are no clear guidelines on the best intensity of walking to reduce frailty. The specific goal of this project is to compare a high intensity walking (HIW) intervention (70-80% of heart rate maximum) to a moderate intensity walking (MIW) intervention (50-60% of heart rate maximum) for pre-frail or frail older adults to determine the impact on frailty, mobility, balance, quality of life, and healthcare utilization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Receiving services from CJE SeniorLife
  • Pre-frailty or frailty as determined on the SHARE-FI.
  • Able to ambulate at least 10 feet with moderate assistance (<50% physical assistance) or less. Participants will be able to use their assistive device (e.g. cane or walker) during sessions.
  • > 65 years of age
  • Provision of informed consent and clearance for participation as determined by the Exercise and Screening for You (EASY)

排除标准

  • Uncontrolled cardiovascular, metabolic, renal, or respiratory disease that limits exercise participation (e.g., previous heart attack within 3 months of enrollment or uncontrolled diabetes)
  • Resting blood pressure > 180/110 mmHg.59

结局指标

主要结局

Change in frailty as measured by the Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI)

时间窗: Baseline, Week 9, Month 6

Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI) which assesses fatigue, appetite, weakness, walking difficulties, and low physical activity

次要结局

  • Improved mobility as measured by 6 Minute Walk Test(Baseline, Week 9, Month 6)
  • Monthly self reports of Health Care Utilization(Baseline, Week 9, Month 3, Month 4, Month 5, Month 6)
  • Improved mobility as measured by Time Up and Go(Baseline, Week 9, Month 6)
  • Improved balance as measured by the Berg Balance Scale(Baseline, Week 9, Month 6)
  • Improved mobility as measured by gait speed(Baseline, Week 9, Month 6)
  • Patient Reported Outcomes Measure Information System (PROMIS) Global Health(Baseline, Week 9, Month 6)
  • Improved physical function on the Short Physical Performance Battery(Baseline, Week 9, Month 6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Margaret Danilovich

Assistant Professor

Northwestern University

研究点 (2)

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