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临床试验/NCT02720276
NCT02720276已完成不适用

Sms Guided Training After Acute Stroke: A Pilot Study

Uppsala County Council, Sweden0 个研究点目标入组 19 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
主要终点
6 Minutes Walk Test

研究概览

简要总结

The purpose of this exploratory study is to investigate how a predetermined outdoor walking program (12 weeks) is best delivered to individuals with stroke over 18 years, either by smartphone and the Short Message Service (SMS) or video link.

Furthermore, the aim is to investigate how the study design works in practice and determine the effects of the outdoor walking exercise program in combination with a leg exercise on physical functioning (walking capacity, gait speed, mobility and grip strength).

详细描述

Twenty community-living individuals in Uppsala municipality will be included and treated with a cross-over design. Ten individuals will initially receive exercise instructions to their smartphones via Short Message Service (SMS) for 6 weeks and after that instructions by a video link (6 weeks). Another 10 individuals will initially receive instructions by a video link and then switching to management with SMS after 6 weeks of training.

Intervention: Participants are supposed to perform an outdoor walking exercise program for 12 weeks. The walks should gradually increase in frequency and intensity, and is expected to start after discharge from the stroke department, after the assessment. The first 2 weeks start with daily walks. The walks will be conducted at a pace that increases the heart rate but still makes it possible to talk. The intensity and frequency of walks will progressively increase performed according to the Borg scale: 12-15, ie, moderate to strenuous. Participants will walk 5-7 days/week. Added to this is a strength exercise, which should be performed in connection with the walk training.

Methods: Questionnaires and medical records used for documentation of age, sex, comorbidity, blood pressure, medications and previous education.

Assessment of motor function, cognition, level of physical activity are only performed as screening at baseline measurements. Objective evaluation of the participants' adherence to the outdoor walking program will be measured with a training diary where the individual documents whether they have followed the training instructions.

Power analysis is not performed since this is an exploratory study. The investigators will analyze the data using an intention-to -treat. The investigators will also do a 'per-protocol analysis, where only participants who completed the training are included. Participants should have participated in at least 50% of the training sessions. All analyzes will be done using SPSS version 23 (IBM, Armonk).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Verified ischemic cerebral infarction or intracerebral hemorrhage.
  • Sufficient walking capacity and motor function
  • Able to communicate in Swedish
  • Signed consent

排除标准

  • Are one or more of the following:
  • Subarachnoid bleeding
  • Insufficient cognition and impaired ability to understand instructions
  • Medical problems that make it unsuitable to participate

研究组 & 干预措施

Training after acute stroke

Experimental

Intervention: Outdoor walking and strength training.

干预措施: Training after acute stroke (Other)

结局指标

主要结局

6 Minutes Walk Test

时间窗: change from baseline walking capacity to three months

walking capacity

次要结局

  • Montreal Outcome Assessment(baseline)
  • Modified Rankin Scale(baseline)
  • Jamar hand dynamometer(change from baseline hand-grip strength to three months)
  • 10 meters walk test(change from baseline gait speed to three months)
  • Short Physical Performance Battery(change from baseline mobility to three months)
  • Saltin Grimby Physical Activity Level Scale(baseline)
  • The Visual Analogue Rating Scale (VAS)(change from baseline to three months.)

研究者

发起方
Uppsala County Council, Sweden
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Birgit Vahlberg

Med Dr, RPT

Uppsala County Council, Sweden

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