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临床试验/NCT03590665
NCT03590665
终止
不适用

Central & Peripheral Blood Flow Regulations in Individuals With Down Syndrome

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 21 人2018年3月1日
适应症Down Syndrome

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Down Syndrome
发起方
University of Illinois at Chicago
入组人数
21
试验地点
1
主要终点
Brachial blood flow
状态
终止
最后更新
6年前

概览

简要总结

This study focuses on physiological explanations of difficulties with physical activity and exercise in individuals with Down syndrome, by non-invasively examining cardiac output and the regulation of blood flow to working muscles during exercise.

详细描述

Work capacity is an important predictor of declining health or physical function, and of mortality, and is commonly measured as peak oxygen consumption. Peak oxygen consumption is very low in individuals with Down syndrome, the most prevalent genetic cause of intellectual disability. Previous research suggests individuals with Down syndrome may experience a double disadvantage when they are exercising: they may not be able to increase cardiac output sufficiently and they may not be able to allocate adequate blood flow to the working muscles. The aim of this research study is therefore to determine the impact of limitations in central and peripheral regulation of blood flow on work capacity in individuals with DS. The results of this project will aid our understanding of the underlying mechanisms and determine the potential to improve health across the lifespan of individuals with Down syndrome by tailoring exercise interventions.

注册库
clinicaltrials.gov
开始日期
2018年3月1日
结束日期
2019年5月8日
最后更新
6年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Thessa Hilgenkamp

Postdoctoral fellow

University of Illinois at Chicago

入排标准

入选标准

  • Between 18 and 45 years old
  • generally healthy
  • sedentary or low-active (defined as being involved in less than 30 minutes of moderately-intense physical activity per day)
  • additionally for the participants with Down syndrome:
  • diagnosis of Down syndrome trisomy 21 and
  • normal thyroid function or stable thyroid function (and medications) for at least 6 months.

排除标准

  • atherosclerotic or other vascular disease;
  • asthma or other pulmonary disease;
  • hypertension (defined BP \>140/90 mmHg);
  • blood pressure below 90/60 mmHg;
  • history of pre-syncope or syncope;
  • diabetes (defined as Hba1c of \>7.5% or use of glucose lowering medication);
  • severe obesity (defined as BMI \>40);
  • medications affecting heart rate, blood pressure or arterial function;
  • anti-inflammatory medication including NSAIDS;
  • current smoking and

结局指标

主要结局

Brachial blood flow

时间窗: In minute 4 of the 5-minute bout of grip strength exercise

Forearm blood flow and vascular conductance will be measured in both the exercising and non-exercising arm using high definition ultrasound (Alpha 7, Aloka-Hitachi). The brachial artery will be imaged in dual mode allowing for simultaneous determination of artery diameter (B-mode) and flow velocity (Doppler mode). Blood flow will be determined from the following formula: Forearm Blood flow = (Mean blood velocity) x (Brachial Cross Sectional Area) x (60) and expressed as ml/min. Forearm vascular conductance will be determined by dividing forearm blood flow by mean arterial pressure. Forearm blood flow and vascular conductance will be normalized to forearm lean mass to account for differences in lean mass between individuals.

次要结局

  • Muscle oxygenation(In minute 4 of the 5-minute bout of grip strength exercise)
  • Cardiac outut(Every second minute until the 12th minute of the maximal test.)

研究点 (1)

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