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临床试验/NCT03916952
NCT03916952已完成不适用

The Effects of Guarding on the Outcomes of the Six Minute Walk Test

Concordia University, St. Paul1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2017年6月11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
205
试验地点
1
主要终点
Gait Speed

研究概览

简要总结

This study was designed to determine if walking with a healthy individual during the 6 minute walk test significantly influenced the outcome of the test.

详细描述

Introduction

The American Thoracic Society recommends not walking with the patient or client during the Six Minute Walk Test (6MWT). However, this recommendation raises safety concerns for individuals at increased risk of falls. Given the recommendations and concerns, the effects of guarding during the 6MWT has not been investigated. Purpose: The purpose of this study was to determine if guarding during the 6MWT affected gait speed and distance walked. Methods: Participants were randomized into a 'guarded first' vs 'guarded second' condition. Data were analyzed using a one-sample t-test, Pearson Correlation Coefficients, Intraclass Correlation Coefficients (ICC), and Bland Altman plots to assess differences and relationships for gait speed and distance walked between the guarded and unguarded trials.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Young Group
  • Between 18 and 50 years of age
  • Independent with ambulation such that no physical assistance was required during the 6MWT
  • No pertinent acute or chronic medical conditions.
  • Older adult group
  • 50 years of age or older Ambulatory without requiring physical assistance Intact cognition as determined by achieving a score of 24 on the Mini Mental Status Exam
  • Stable balance by scoring a minimum of 18cm (7 inches) on the Functional Reach Test

排除标准

  • All Participants:
  • Unstable angina
  • History of myocardial infarction 30 days prior to the study
  • Resting heart rate greater than 120 beats per minute
  • Resting systolic blood pressure greater than 180 mmHg
  • Resting diastolic blood pressure greater than 100 mmHg
  • Symptoms were reported or observed that were consistent with low blood pressure
  • Recent injury, surgery or medical procedure.
  • Older Participants:
  • Functional Reach Test (<18cm or 7 inches)
  • Mini Mental Exam (score < 24).

结局指标

主要结局

Gait Speed

时间窗: 6 Minutes

How fast the patient was able to ambulate

Distance Walked

时间窗: 6 Minutes

How far the patient was able to ambulate

次要结局

未报告次要终点

研究者

发起方
Concordia University, St. Paul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristin Lefebvre

Principle investigator

Concordia University, St. Paul

研究点 (1)

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