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NCT05528549 · ClinicalTrials.gov registry record · Phase 3
Blood Flow and Blood Pressure Investigation in Down Syndrome
A Phase 3 study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- Phase 3
- Development phase
- 48
- Enrollment target
NCT05528549: Completed Phase 3 study, sponsored by University of Illinois at Chicago.
NCT05528549 is a Phase 3 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 48 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05528549, a Phase 3 study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 48 participants
- Enrollment target
Study Summary
Down syndrome (DS) is a chromosomal condition that occurs in approximately 1 in 800 births worldwide, and causes impairments in physical function, including a reduced work capacity (as measured by VO2peak or aerobic capacity). Work capacity is important for activities of daily living, in order to live longer, healthier lives. Reduced work capacity stems in large part from autonomic dysfunction, which has been described in individuals with DS. Individuals with DS experience reduced sympathetic and parasympathetic control, which results in alterations in resting heart rate, blood pressure, and attenuated responses to sympathoexcitatory stimuli. Autonomic dysfunction may impair the ability to regulate blood flow and blood pressure to working muscles during exercise, which may cause a mismatch between oxygen supply and demand, further compromising the already reduced work capacity observed in individuals with DS. Utilization of a large muscle mass exercise, such as lower-limb dynamic exercise (similar to walking), requires a large shift in blood flow to match metabolic demand and allows the opportunity to evaluate blood flow regulation. Conversely, examination of the large changes in pressure in response to isometric exercise (i.e., a sustained contraction), allows for examination of the exercise pressor reflex as evoked by the isometric contraction. Thus, by comprehensively evaluating blood flow and blood pressure regulation, our work will further elucidate the mechanisms that underlay the reduced work capacity in individuals with DS. Improvement of overall work capacity for a population with reduced work capacity will guide future studies and exercise interventions aimed at helping to improve independence and quality of life, ultimately allowing individuals with DS to live longer, healthier lives. Aim 1 (Dynamic Exercise): To examine the effects of an acute bout of dynamic leg kicking at both relative and absolute intensity workloads on femoral blood flow to both exe
Primary Outcome
The investigators will use a Doppler ultrasound machine to assess lower limb blood flow during repeated leg contractions.
Interventions
- OTHER Exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2023-04-26 |
| Phase | Phase 3 |
What the finished NCT05528549 record still lists
NCT05528549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Exercise is the first listed.
NCT05528549 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05528549 about?
NCT05528549 is a clinical study titled "Blood Flow and Blood Pressure Investigation in Down Syndrome". Down syndrome (DS) is a chromosomal condition that occurs in approximately 1 in 800 births worldwide, and causes impairments in physical function, including a reduced work capacity (as measured by VO2peak or aerobic capacity). Work capacity is important for activities of daily living, in order to li...
What is the current status of trial NCT05528549?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2022-09-01. Estimated completion is 2023-04-26.
What interventions are being tested in trial NCT05528549?
The interventions under investigation include: Exercise (OTHER).
Who is sponsoring clinical trial NCT05528549?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05528549's enrollment target sits among peer trials
48 1862nd of 2000 higher than 134 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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