Down SyndromeNCT03590665
Blood Flow in Individuals With Down Syndrome
A study testing Hand grip exercise and lower body negative pressure in people with Down Syndrome, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Hand grip exercise and lower body negative pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 8 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 11Show fewer
- severe obesity (defined as BMI >40);
- medications affecting heart rate, blood pressure or arterial function;
- anti-inflammatory medication including NSAIDS;
- current smoking and
- pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Disability, Health, and Social Policy Building, Integrative Physiology Laboratory, Suite 158 at 1640 W. Roosevelt Rd
Chicago, Illinois, 60608
About this study
Official title: Central & Peripheral Blood Flow Regulations in Individuals With Down Syndrome
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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- Hand grip exercise and lower body negative pressure
- Keywords
- exercise, blood flow, strength, blood pressure, heart rate,
- Medical subject headings
- Down Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand grip exercise and lower body negative pressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Down syndrome | Other | 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. Receives: Other: Hand grip exercise and lower body negative pressure |
| Individuals without Down syndrome | Other | 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. Receives: Other: Hand grip exercise and lower body negative pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial blood flow
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.
Measured: In minute 4 of the 5-minute bout of grip strength exercise
Secondary outcomes (2)
Muscle oxygenation
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.
Measured: In minute 4 of the 5-minute bout of grip strength exercise
Cardiac outut
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.
Measured: Every second minute until the 12th minute of the maximal test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Mar 2018
- Primary completion8 May 2019
- Study completion8 May 2019
Why it stopped: PI accepted a position at a new Institution and terminated the study at UIC.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Thessa Hilgenkamp, University of Illinois Chicago
- Investigators
- Thessa Hilgenkamp, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590665
- Sponsor's protocol ID
- 2017-0642
- Other IDs
- 1K99HD092606-01
- Status last verified
- Jul 2019
- First submitted
- 21 Jun 2018
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central & Peripheral Blood Flow Regulations in Individuals With Down Syndrome
- ClinicalTrials.gov ID
- NCT03590665
- Acronym / sponsor ID
- 2017-0642
- Conditions
- Down Syndrome
- Keywords
- exercise, blood flow, strength, blood pressure, heart rate,
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI accepted a position at a new Institution and terminated the study at UIC.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 8 May 2019 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individuals with Down syndrome | Other | Other: Hand grip exercise and lower body negative pressureFor 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 | Other | Other: Hand grip exercise and lower body negative pressureFor 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand grip exercise and lower body negative pressureFor 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 with Down syndrome, Individuals without Down syndrome |
Primary outcome
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.
2 secondary outcomes
Muscle oxygenation
Time frame: In minute 4 of the 5-minute bout of grip strength exercise
Cardiac outut
Time frame: Every second minute until the 12th minute of the maximal test.
Results and safety
The study was stopped early (reason given: PI accepted a position at a new Institution and terminated the study at UIC.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thessa Hilgenkamp, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand grip exercise and lower body negative pressure in people with Down Syndrome, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI accepted a position at a new Institution and terminated the study at UIC.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial blood flow (time frame: In minute 4 of the 5-minute bout of grip strength exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.