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Exercise for Down Syndrome (FBI21 Trial)
Phase 3
Waitlist Available
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during study visit 2, blood pressure will be measured as a change from baseline blood pressure to leg contraction blood pressure. it will also be measured as a change in baseline blood pressure to post leg contraction blood flow.
Awards & highlights
Summary
This trial will help to elucidate why people with Down Syndrome have reduced work capacity, and how this can be improved.
Eligible Conditions
- Down Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during study visit 2, blood pressure will be measured as a change from baseline blood pressure to leg contraction blood pressure. it will also be measured as a change in baseline blood pressure to post leg contraction blood flow.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during study visit 2, blood pressure will be measured as a change from baseline blood pressure to leg contraction blood pressure. it will also be measured as a change in baseline blood pressure to post leg contraction blood flow.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood Flow
Blood Pressure
Trial Design
2Treatment groups
Experimental Treatment
Group I: Static ExerciseExperimental Treatment1 Intervention
The investigators will look at blood pressure responses to a sustained leg kick. Blood pressure should increase during the sustained contraction for people without Down syndrome.
Group II: Dynamic ExerciseExperimental Treatment1 Intervention
The investigators will look at leg blood flow during a seated leg-kicking test that is similar to biking. Leg blood flow will be measured in both the active and inactive legs. These measurements will be taken to examine how blood is directed (or controlled) during exercise.
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Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
618 Previous Clinical Trials
1,563,990 Total Patients Enrolled
1 Trials studying Down Syndrome
21 Patients Enrolled for Down Syndrome
American College of Sports MedicineOTHER
11 Previous Clinical Trials
301 Total Patients Enrolled
Robert Motl, Ph.D.Study ChairUniversity of Illinois at Chicago
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had cancer in the past 6 months.You use tobacco products, vaping, or marijuana.You are between 18 and 45 years old and in good health.You have high blood pressure, even if you take medicine for it.Your blood pressure is too low when resting (less than 90/60 mmHg).Women who are still able to have children and use birth control that is not a pill.You weigh less than 40 kilograms per square meter.You are taking medications that affect your heart rate or metabolism.You have not taken any anti-inflammatory medication in the 7 days before testing.You have diabetes and take medication to lower your blood sugar.You are not able to do leg exercises or have any leg problems that would stop you from kicking while sitting down.People with Down syndrome who have mild to moderate intellectual disability.You have a corrected congenital heart defect if you have Down syndrome.Your thyroid is working normally, or you have been taking the same thyroid medication for at least 6 months.You do not have heart, lung, inflammation, or metabolic problems.
Research Study Groups:
This trial has the following groups:- Group 1: Dynamic Exercise
- Group 2: Static Exercise
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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