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临床试验/NCT05284110
NCT05284110招募中不适用

Breaking up Sedentary Time in Rheumatoid Arthritis: Effects on Vascular Function

Liverpool John Moores University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年12月1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
12
试验地点
2
主要终点
Middle cerebral artery mean velocity (MCAV)

研究概览

简要总结

This study will verify the effects of breaking up sitting time with short bouts of light intensity walking on vascular function in women with rheumatoid arthritis.

详细描述

Women diagnosed with rheumatoid arthritis will participate in this randomized crossover trial. In one of the experimental sessions, the participants will remain 4-h on uninterrupted sitting, and in another day they will perform 3-min light intensity walk every 30 min to break up the sitting position. Vascular function will be assessed before and after each intervention using the following devices/techniques: a) transcranial Doppler ultrasound to assess the middle cerebral artery blood flow velocity at baseline and in response to CO2 breathing (5% CO2 mixture for 3 min), and to repeated sit-to-stand transitions; b) a multi-frequency linear transducer (7-12 MHz) attached to a high-resolution ultrasound machine to assess femoral artery dilation after reactive hyperemia (i.e., flow-mediated dilation); c) a laser Doppler probe attached to the skin surface of the right shin in order to quantify the Laser Doppler flux at baseline and during reactive hyperemia. Additionally, healthy age- and body mass-matched women will be recruited and will only perform the pre-intervention tests.

研究设计

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

盲法说明

The researcher who will perform the vascular analysis will be blinded to the allocation order.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult women diagnosed with RA
  • From the Rheumatology Clinic at the Liverpool University Hospitals NHS Foundation Trust
  • Aged 18-60 yr
  • Non-smoker for at least 6months
  • Able to provide written informed consent.

排除标准

  • Cannot readily read and understand English.
  • Currently smoking or within last 6 months.
  • Alcohol consumption >14units per week.
  • Symptoms of or established cardiovascular disease (except hypertension)
  • Previous stroke or myocardial infarction.
  • History of diabetes or respiratory disease or chronic kidney disease.
  • Musculoskeletal impairment/disability precluding physical activity
  • Unstable medication (change in medication within the 3 months)
  • Aged <18 or > 60 yr
  • Currently pregnant

结局指标

主要结局

Middle cerebral artery mean velocity (MCAV)

时间窗: Change from baseline (hour 0) to hour 4 (post-intervention/control)

MCAV will be assessed using continuous bilateral transcranial Doppler ultrasound.

Middle cerebral artery mean velocity reactivity to carbon dioxide

时间窗: Change from baseline (hour 0) to hour 4 (post-intervention/control)

Participants will breathe a 5% carbon dioxide mixture for 3 min during which time MCAV reactivity to CO2 will be assessed using continuous bilateral transcranial Doppler ultrasound.

Cerebral autoregulation

时间窗: Change from baseline (hour 0) to hour 4 (post-intervention/control)

Participants will be asked to complete a series of repeated sit to stand moves (coached by a member of the research team) for a 5-minute period, during which time MCAV will be assessed using continuous bilateral transcranial Doppler ultrasound. Beat by beat blood pressure will also be assessed using finger photoplethysmography.

次要结局

  • Brachial artery endothelial function(Change from baseline (hour 0) to hour 4 (post-intervention/control))
  • Brachial artery blood flow(Change from baseline to 1-hour/2-hour/3-hour/4-hour)
  • Femoral artery blood flow(Change from baseline to 1-hour/2-hour/3-hour/4-hour)
  • Pain intensity(Change from baseline to 1-hour/2-hour/3-hour/4-hour)
  • Finger blood pressure(Change from baseline (hour 0) to hour 4 (post-intervention/control))
  • Skin blood flow response to hyperemia(Change from baseline (hour 0) to hour 4 (post-intervention/control))
  • Stroop color-word test(Change from baseline (hour 0) to hour 4 (post-intervention/control))
  • Superficial femoral artery endothelial function(Change from baseline (hour 0) to hour 4 (post-intervention/control))
  • California Verbal Learning Test-2(Change from baseline (hour 0) to hour 4 (post-intervention/control))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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