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临床试验/NCT04657029
NCT04657029已完成不适用

The Acute Effects of Aerobic Exercise on Sensorimotor Adaptation in Chronic Stroke

The University of Queensland2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年6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
20
试验地点
2
主要终点
Sensorimotor adaptation change

研究概览

简要总结

A single-blinded crossover study. Participants attended two separate sessions at the university campus, completing an aerobic exercise intervention in one session and a resting control condition in the other session. Sensorimotor adaptation was assessed before and after each session. Participants were twenty people with chronic stroke. Intervention completed was treadmill exercise at mod-high intensity for 30 minutes.

详细描述

Participants Twenty people with chronic stroke participated in the study (aged 61 ± 13 years; 76% male).

Experimental design In a cross-over design, each participant was pseudo-randomised to complete an intervention condition (Treadmill) or control condition (Rest) first, returning at least one week later (washout period) to complete the alternate condition. A minimum washout period of one week was used to allow for any physiological changes due to exercise to return to resting levels, but to minimise any stroke recovery-associated changes to function. Participants were asked to refrain from exercising in the 24 hours prior to their visit. At each visit, participants completed the sensorimotor adaptation task on two occasions, pre and post intervention, resulting in four assessment timepoints (PreControl, PostControl and PreTreadmill, PostTreadmill). The post intervention assessment aimed to commence within 15 minutes of completing the treadmill or rest condition.

Intervention The intervention condition consisted of a single session of moderate-high intensity aerobic exercise (65% of heart rate reserve) for 30 minutes walking on a standard treadmill (Landice L7 treadmill), with arms placed comfortably by participants on the rail (in front) or swinging freely. Information describing the specific features of the training session (e.g. heart rate, blood pressure response, treadmill speed, total distance walked) were recorded to monitor the response to exercise and adherence to the exercise protocol. The single treadmill session included a progressive increase in intensity (usually increased speed, or gradient) to reach the target heart rate (approx. 5 mins) as well as a cooling down period (approx. 5 mins) to allow for participants to return towards resting levels for vital observations. The warm-up and cool-down were included as part of the total 30 minutes of walking exercise. Target heart rates were calculated using the Karvonen method with levels adjusted for those taking heart rate lowering medications (i.e. beta blockers), following methods previously published in post stroke populations. Heart rate was measured using a chest strap monitor (polar-electro) and monitored by a research assistant who facilitated changes in treadmill parameters to enable participants to reach their target. Participants were asked to self-rate their intensity of exercise every 10 minutes verbally using BORG's 6-20 scale rating of perceived exertion. Participants were instructed to walk at a pace that resulted in a rating between 11 (fairly light) and 14 (somewhat hard) on the scale. The control condition involved an equivalent time period (30 minutes) of seated resting where participants were provided with an education session about the impact and effects of stroke by the same research assistant.

Sensorimotor adaptation task Apparatus and setup. Participants were seated in front of a desk (approximately 50 cm from their coronal plane) and asked to move a digitising pen (15.95 cm long, 1.4 cm wide, 17 g) on a digitizing tablet (WACOM Intuos4 PTK 1240, size: 19.2 x 12 in., resolution = 0.25 mm) from an origin to a target point. The pen's position on the tablet (XY coordinates) was sampled at 100 Hz and displayed in real time as a circular cursor with a 5-pixel radius (1.25 mm) on a horizontally placed computer monitor. Direct vision of the hand was prevented by placing the tablet and the hand directly beneath an opaque stand, with the horizontal monitor placed atop the stand.

Task instructions. Participants first received task instructions to move an on-screen cursor from the start to the target, in a straight line, in a single movement, as quickly and as accurately as possible. Further, participants were instructed that the feedback of the movement would be changed from time-to-time, and that participants were to change their movement in response to this change of feedback, whilst keeping movements as straight as possible.

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
Single (Outcomes Assessor)

盲法说明

Blinded Assessors

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of stroke
  • Time of stroke greater than three months ago
  • Be able to walk with or without and aid for at least 10 metres
  • Understand three stage commands

排除标准

  • Unable to walk independently prior to current stroke
  • Have co-morbidities that limit their walking (e.g. arthritis, orthopaedic surgery)
  • Unstable cardiac status
  • Unable to understand three stage commands
  • Unable to provide informed consent

结局指标

主要结局

Sensorimotor adaptation change

时间窗: Pre and Post intervention and Pre and Post Control. There was one week between the two conditions

Participants were seated in front of a desk and asked to move a digitising pen on a digitizing tablet from an origin to a target point. The pen's position on the tablet (XY coordinates) was sampled at 100 Hz and displayed in real time as a circular cursor with a 5-pixel radius (1.25 mm) on a horizontally placed computer monitor. Direct vision of the hand was prevented by placing the tablet and the hand directly beneath an opaque stand, with the horizontal monitor placed atop the stand.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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