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临床试验/NCT04586725
NCT04586725Unknown不适用

The Effect of Encouragement on Six Minute Walk Test Performance in Patients With Intermittent Claudication

University of Central Lancashire0 个研究点目标入组 76 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
76
主要终点
Maximal walking distance (MWD)

研究概览

简要总结

Peripheral artery disease (PAD) is characterised by a build up of fatty plaque in the arteries in the lower limbs, resulting in a reduction of blow flow to the muscles. Globally, it is estimated that 236 million people are living with PAD. A classic symptom of PAD is intermittent claudication (IC) which is characterised by muscle cramps in the lower limbs, typically brought on by exercise and relieved at rest. Exercise is recommended at first line treatment for IC. However to assess IC symptoms in response to an exercise study, maximal walking capacity (the furthest they can walk before it becomes too painful to walk) is typically the main measure. A patients walking capacity is assessed by a number of exercise testing protocols including the six-minute walk test (6MWT), where patients walk for six minutes with the aim to walk as far as they can in the time allotted. Patient encouragement has been shown to improve walking performance by as much as 30 meters in heart failure and respiratory disease populations. However the effect of encouragement on walking performance in people with IC is yet to be studied.

详细描述

Peripheral artery disease (PAD) is characterised by atherosclerotic lesions of the arteries in the lower limbs, resulting in a reduction of blow flow (Hiatt, 2001). Globally, it is estimated that 236 million people are living with PAD, with the number of cases increasing by 24% from 2000 to 2010. A classic symptom of PAD is intermittent claudication (IC), characterised by ischemic muscle pain precipitated by exertion and relieved by rest. IC is associated with various comorbidities such as diabetes mellitus, hypertension and dyslipidaemia as well as reductions in physical function, quality of life, and balance. National and international guidelines recommend supervised exercise therapy as first line treatment for patients with IC.

To assess IC impairment in response to an exercise intervention, maximal walking capacity is typically the primary outcome in randomised controlled trials (RCT's). This involves a patient walking for as long as possible until ischemic leg symptoms, fatigue or other symptoms prevent them from continuing. This is assessed by a number of exercise testing protocols including the six-minute walk test (6MWT). The American Thoracic Society provide guidelines for performing a standardised 6MWT including verbal phrases that are conducted every minute. Conversely, Montgomery and Gardner suggest encouragement every two minutes. Encouragement has been shown to significantly affect walking performance by as much as 30 meters in heart failure and respiratory disease populations. However the effect of encouragement on walking performance in people with IC is yet to be investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants will be blinded to the level of encouragement they will receive during the tests

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

  • >18 years old
  • Resting ankle brachial pressure index (ABPI) <0.9 or a reduction of ≥ 20 mmHg following exercise testing (per site protocol)
  • Able to walk unaided
  • English speaking and able to follow exercise instructions
  • Able to provide informed consent

排除标准

  • Those who have critical limb threatening ischaemia (rest pain and/or tissue loss)
  • Unable to provide consent
  • Those presenting with any significant comorbidities or contraindications to exercise testing or training in accordance to the American College of Sports Medicine
  • Uncontrolled or symptom limiting coronary heart or pulmonary disease

结局指标

主要结局

Maximal walking distance (MWD)

时间窗: 6 weeks

Metres walked during the tests

次要结局

  • Learning effect metres walked(6 weeks)

研究者

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

Stefan Birkett

Lecturer In Exercise Science

University of Central Lancashire

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