- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03590665
Blood Flow in Individuals With Down Syndrome
Central & Peripheral Blood Flow Regulations in Individuals With Down Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60608
- Disability, Health, and Social Policy Building, Integrative Physiology Laboratory, Suite 158 at 1640 W. Roosevelt Rd
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Individuals with Down syndrome
For participants with Down syndrome, the first visit includes baseline measures and familiarization with the graded maximal exercise test protocol.
If necessary, additional familiarization sessions will be scheduled for people with Down syndrome.
The second visit, we perform the graded maximal exercise test and familiarize the participant with the procedures for the third visit: the hand grip exercise protocol and the lower body negative pressure (LBNP) box.
The third visit we assess the peripheral blood flow during the hand grip exercise protocol without and with the LBNP.
For control subjects, the first and second visit are combined.
Their second visit is the same as the third visit for individuals with Down syndrome.
|
For participants with Down syndrome, the first visit includes baseline measures and familiarization with the graded maximal exercise test protocol.
If necessary, additional familiarization sessions will be scheduled for people with Down syndrome.
The second visit, we perform the graded maximal exercise test and familiarize the participant with the procedures for the third visit: the hand grip exercise protocol and the lower body negative pressure (LBNP) box.
The third visit we assess the peripheral blood flow during the hand grip exercise protocol without and with the LBNP.
For control subjects, the first and second visit are combined.
Their second visit is the same as the third visit for individuals with Down syndrome.
|
Other: Individuals without Down syndrome
For participants with Down syndrome, the first visit includes baseline measures and familiarization with the graded maximal exercise test protocol.
The second visit, we perform the graded maximal exercise test and familiarize the participant with the procedures for the third visit: the hand grip exercise protocol and the lower body negative pressure (LBNP) box.
The third visit we assess the peripheral blood flow during the hand grip exercise protocol without and with the LBNP.
For control subjects, the first and second visit are combined.
Their second visit is the same as the third visit for individuals with Down syndrome.
|
For participants with Down syndrome, the first visit includes baseline measures and familiarization with the graded maximal exercise test protocol.
If necessary, additional familiarization sessions will be scheduled for people with Down syndrome.
The second visit, we perform the graded maximal exercise test and familiarize the participant with the procedures for the third visit: the hand grip exercise protocol and the lower body negative pressure (LBNP) box.
The third visit we assess the peripheral blood flow during the hand grip exercise protocol without and with the LBNP.
For control subjects, the first and second visit are combined.
Their second visit is the same as the third visit for individuals with Down syndrome.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brachial blood flow
Time Frame: 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.
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In minute 4 of the 5-minute bout of grip strength exercise
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle oxygenation
Time Frame: In minute 4 of the 5-minute bout of grip strength exercise
|
Muscle oxygenation will be measured with near-infrared spectography (NIRS), which is a simple, noninvasive method for measuring the presence of oxygen in muscle.
It can monitor changes in muscle oxygenation and blood flow during submaximal and maximal exercise.
During exercise, the extent to which skeletal muscles deoxygenate varies according to the type of muscle, type of exercise and blood flow response.
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In minute 4 of the 5-minute bout of grip strength exercise
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Cardiac outut
Time Frame: Every second minute until the 12th minute of the maximal test.
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Cardiac output will be measured during a graded maximal test protocol using ultrasonography, by measuring the aortic diameter at the level of the valve form the peristernal long axis.
Ascending aortic blood flow will be measured using continuous Doppler echocardiography using a pedoff probe in the suprasternal notch.
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Every second minute until the 12th minute of the maximal test.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Thessa Hilgenkamp, PhD, University of Illinois at Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-0642
- 1K99HD092606-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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