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临床试验/NCT04623060
NCT04623060Unknown不适用

Feasibility of Low-Volume Interval Training and Resistance Exercise on Walking Performance, Aerobic Fitness, Muscle Strength and Quality Of Life in Individual With Stroke

Universiti Teknologi Mara2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Change in Six Minute Walk Test

研究概览

简要总结

To examine the feasibility of Low-Volume Interval Training (LV-ITT) and Resistance Exercise (RE) on walking performance (walking endurance, gait speed, functional balance), lower limb muscle strength and quality of life among individuals with post-stroke.

详细描述

Prescribing aerobic and resistance training in concurrence is proposed as an optimum strategy to target cardiovascular as well as musculoskeletal functions in individuals with post-stroke. Lower limb's resistance training alone in chronic stroke produces a large effect on muscle strength. However, it has shown uncertainty results on walking performance. Therefore, it is suggested that to prescribe mix training (treadmill training and strength training) in order to improve muscle strength, gait performance and quality of life in stroke survivors. Previous studies have shown the effect of mixed training on walking performance and endurance in other populations such as multiple sclerosis and coronary artery disease. However, there is a lack of study that conducted mixed training among chronic post-stroke. Therefore, the feasibility study on the effectiveness of combining LV-ITT and RE in post-stroke should be conducted.

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
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age range between 45-65 years' old
  • At least 3-months post-stroke
  • Gait speed ≤1.0 m·s -¹ measured by the 10 m walk test.
  • Able to walk 10 m overground with assistive devices as needed and no physical assistance.
  • Able to walk for 3 min on the treadmill at ≥0.17 m·s -¹ (0.4 mph) with no aerobic exercise contraindications.
  • Modified Rankin Score (mRS) of <4 at the screening
  • American Heart Association class B (2), allowing for aerobic capacity <6 metabolic equivalent (MET)

排除标准

  • Significant resting ECG abnormalities
  • Hospitalization for cardiac or pulmonary disease within 3 months
  • Using Pacemaker
  • Significant musculotendinous or bony restrictions of the affected limb, or any serious chronic disease independently causing disability or profound atrophy of the affected limb that will comprise further indications to participation significant.

结局指标

主要结局

Change in Six Minute Walk Test

时间窗: 0, 6 weeks

This test measures the distance that an individual can quickly walk in a period of 6 minutes on a flat surface. Participants will complete one trial with the gait aide prescribed to them. The distance will be recorded. Participants can stop and rest or discontinue to the test at any time.

次要结局

  • Change in Timed Up and Go test(0, 6 weeks)
  • Patient satisfaction(6 weeks)
  • Change in 10-meter walk test(0, 6 weeks)
  • Change in Lower Limb Muscle Strength(0, 6 weeks)
  • Adherence(0 to 6 weeks)
  • Stroke Impact Scale (SIS)(0,week 6)
  • Adverse Events(0 to 6 weeks)

研究者

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

Mohd Haidzir Abd Manaf

Associate Professor

Universiti Teknologi Mara

研究点 (2)

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