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临床试验/NCT05553223
NCT05553223招募中不适用

Can Micro-doses of Physical Activity Offset the Negative Cardiovascular Consequences of Being Sedentary in Patients With COPD?

University of British Columbia2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Change in superficial femoral artery endothelial function

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is a disease of the lungs that makes it hard for people to breath. Those with COPD spend considerably more time sitting and lying and less time performing physical activity than healthy individuals. Those who are the most sedentary have a greater risk of heart and blood vessel disease, which may lead to an early death. This project will investigate the effect of sitting still for 3 hours on blood vessel health in individuals with COPD. It will also investigate whether breaking up the amount of time patients sit with regular short bouts of walking (5 minutes each hour) at a comfortable pace chosen by the patient can have a positive effect on maintaining the health of their blood vessels. It is hypothesized that blood vessel health will be worse after 3 hours of sitting compared to when the sitting is broken up by short bouts of walking.

详细描述

The Purpose of the Study:

The aim of the proposed study is to examine whether regular microdoses of low intensity physical activity (PA) can reduce the vascular dysfunction and adverse cardiovascular consequences associated with being sedentary in patients with COPD.

Hypothesis to be Tested:

Primary Hypothesis: Endothelial function (measured as superficial femoral flow mediated dilation) will be reduced in patients with COPD after 3-hours of prolonged sitting compared to the same duration of sitting interspersed with micro-doses of PA (5 min/hour of walking).

Secondary Hypothesis: Superficial femoral endothelial shear rate and antegrade blood flow will be reduced and retrograde blood flow and arterial stiffness will be increased following prolonged sitting compared to the same duration of sitting interspersed with micro-doses of PA. Mean 24-hour blood pressure will be lower when micro-doses of PA are used to reduce sedentary time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The investigator who will analyze the primary outcome data will be blinded to the participant and condition.

入排标准

性别
All
接受健康志愿者

入选标准

  • Non-smoking (>6 months) patients with stable moderate-to-severe COPD (post bronchodilator forced expired volume in 1 sec/forced vital capacity<0.7 and <lower limit of normal, 30%<Forced Expired Volume in 1 sec<80% predicted and exacerbation free for >6 weeks) will be recruited for the study.

排除标准

  • performing structured exercise training (or pulmonary rehabilitation)
  • have a history of deep vein thrombosis
  • are on anticoagulant medication
  • have advanced cardiac or cerebrovascular disease (i.e. heart failure, previous stroke or myocardial infarction)
  • have diabetes
  • have musculoskeletal contraindications that limit their ability to perform physical activity
  • vascular ultrasound measurements cannot be obtained.

结局指标

主要结局

Change in superficial femoral artery endothelial function

时间窗: Within 3 hours of sitting (Day1) or within 3 hours of micro-doses of physical activity (Day 2). Days performed in a randomized order.

The change in endothelial function (measured by the flow-mediated dilation response to reactive hyperaemia of the superficial femoral artery using ultrasound) from baseline to 3-hours of prolonged sitting in the control condition compared to performing 3-hours of sitting broken up by micro-doses of physical activity.

次要结局

  • Change in superficial femoral artery blood flow patterns(Within 3 hours of sitting (Day1) or within 3 hours of micro-doses of physical activity (Day 2). Days performed in a randomized order.)
  • Difference in 24-hour ambulatory blood pressure between the two conditions(Within 24 hours of sitting (Day 1) or within 24 hours of micro-doses of physical activity (Day 2). Days performed in a randomized order.)

研究者

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

Neil Eves

Professor

University of British Columbia

研究点 (2)

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