Clinical trial NCT03590665: Blood Flow in Individuals With Down Syndrome
Official title: Central & Peripheral Blood Flow Regulations in Individuals With Down Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Down Syndrome
Keywords: exercise, blood flow, strength, blood pressure, heart rate,
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-07-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The acute response to exercise in blood flow is non-invasively assessed in group of individuals with Down syndrome and a control group of age- and sex-matched individuals without Down syndrome.
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* pregnancy.

Primary outcomes:
measure: Brachial blood flow
timeFrame: In minute 4 of the 5-minute bout of grip strength exercise
Secondary outcomes:
measure: Muscle oxygenation
timeFrame: In minute 4 of the 5-minute bout of grip strength exercise
measure: Cardiac outut
timeFrame: Every second minute until the 12th minute of the maximal test.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Disability, Health, and Social Policy Building, Integrative Physiology Laboratory, Suite 158 at 1640 W. Roosevelt Rd
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Thessa Hilgenkamp, PhD
role: PRINCIPAL_INVESTIGATOR
References: