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临床试验/NCT05720013
NCT05720013已完成不适用

Acute Effects of Beetroot Juice on Locomotor Economy and Capacity in Chronic Stroke

Indiana University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年2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
22
试验地点
2
主要终点
Changes in gait efficiency during steady state walking

研究概览

简要总结

The purpose of this study is to investigate if a beetroot juice supplement can improve oxygen capacity during walking tasks at a submaximal and maximal effort in people greater than 6 months following stroke.

详细描述

During this study, participants will perform baseline measurements such as walking and balance tests. During baseline testing, participants will be asked to perform a maximal exertion test while walking on a treadmill to determine the speed for a submaximal walking test. One week after baseline testing, the participant will have an intervention session where they drink either a beetroot juice supplement or a placebo. The placebo will taste similar to the beetroot juice and participants may not be able to tell the difference between the two different supplements. After a week, the participant will return to the lab and drink the other supplement. For example, if the participant drank the beetroot juice in the first session, then they will drink the placebo in the second session. During each intervention session, the participant will be asked to perform two treadmill tests, one with submaximal effort and one with maximal effort. After the walking tests, they will drink either the beetroot juice or placebo and have their blood drawn. They will wait at the hospital for 2-3 hours and have their blood drawn again. The participants will then complete the two treadmill tests again. The two intervention sessions will last about 4-6 hours for each session. Participation in the study will last 4-6 weeks including screening and baseline testing.

研究设计

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults aged 18-89 years
  • diagnosis of chronic hemiparesis following unilateral stroke (greater than six months)
  • ability to ambulate at least 0.3 m/s, with or without using an assistive device or bracing below the knee
  • ability to read and understand English
  • follow three-step commands

排除标准

  • presence of cerebellar deficits
  • any other neurological or orthopedic deficits that would limit walking ability
  • cannot receive physical therapy for gait-related impairments
  • uncontrolled metabolic, respiratory, and cardiovascular disease

结局指标

主要结局

Changes in gait efficiency during steady state walking

时间窗: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion

Oxygen Consumption during steady state walking prior to and following placebo or beetroot juice ingestion

Changes in plasma levels of Nitrate and Nitrite

时间窗: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion

Blood samples taken prior and following ingestion of either the beetroot juice or placebo supplements.

次要结局

  • Changes in peak Treadmill Speed(Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion)
  • Changes in peak oxygen consumption during maximum gait speed(Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.)
  • Changes in peak heart rate during the graded treadmill test(Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.)

研究者

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

George Hornby

Professor

Indiana University

研究点 (2)

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