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Trial record 2 of 45 for:    Recruiting, Not yet recruiting, Available Studies | "Down Syndrome"

Blood Flow in Individuals With Down Syndrome

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ClinicalTrials.gov Identifier: NCT03590665
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Down Syndrome Other: Hand grip exercise and lower body negative pressure Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Central & Peripheral Blood Flow Regulations in Individuals With Down Syndrome
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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: Hand grip exercise and lower body negative pressure
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.

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.
Other: Hand grip exercise and lower body negative pressure
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Cardiac outut [ Time Frame: Every second minute until the 12th minute of the maximal test. ]
    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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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590665


Contacts
Contact: Thessa Hilgenkamp, PhD 3129969607 thessa@uic.edu
Contact: Bo Fernhall, PhD 312-996-6695 fernhall@uic.edu

Locations
United States, Illinois
Disability, Health, and Social Policy Building, Integrative Physiology Laboratory, Suite 158 at 1640 W. Roosevelt Rd Recruiting
Chicago, Illinois, United States, 60608
Contact: Thessa Hilgenkamp, PhD    312-996-9607    thessa@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Thessa Hilgenkamp, PhD University of Illinois at Chicago

Responsible Party: University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03590665     History of Changes
Other Study ID Numbers: 1K99HD092606-01 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Illinois at Chicago:
exercise, blood flow, strength, blood pressure, heart rate,

Additional relevant MeSH terms:
Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn