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Exercise for Down Syndrome (FBI21 Trial)

Phase 3
Recruiting
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
18-45 yrs old and apparently healthy individuals
BMI <40kg/m2
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

FBI21 Trial 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

FBI21 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 18 and 45 years old and in good health.
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You weigh less than 40 kilograms per square meter.
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People with Down syndrome who have mild to moderate intellectual disability.
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You have a corrected congenital heart defect if you have Down syndrome.
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Your thyroid is working normally, or you have been taking the same thyroid medication for at least 6 months.
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You do not have heart, lung, inflammation, or metabolic problems.

FBI21 Trial 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

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

FBI21 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.

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
605 Previous Clinical Trials
1,559,209 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

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05528549 — Phase 3
Down Syndrome Research Study Groups: Dynamic Exercise, Static Exercise
Down Syndrome Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT05528549 — Phase 3
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05528549 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I get involved in this experiment?

"This clinical trial is only accepting 36 patients that currently have down syndrome and fall between the ages of 18-45. Furthermore, it is vital that these patients meet the following additional criteria: being free from any cardiovascular, pulmonary, inflammatory, or metabolic diseases; having a BMI that is below 40kg/m2; and, for individuals with DS, that they have mild to moderate intellectual disability and corrected congenital heart disease."

Answered by AI

Are investigators looking for more subjects for this research?

"Based on the information available on clinicaltrials.gov, it seems as though this study is still recruiting patients. The study was originally posted on September 1st, 2022 and was most recently updated on September 27th, 2022. So far, 36 patients have been enrolled at 1 location."

Answered by AI

What is the risk profile for patients who engage in Exercise?

"Exercise is considered safe according to our team's assessment, as it is a phase 3 trial with some data supporting its efficacy and multiple rounds of data supporting its safety."

Answered by AI

If a person is over the age of 50, can they still participate in this experiment?

"Eligibility for this particular study is restricted to patients aged 18-45. However, there are other ongoing trials that welcome patients who are under 18 (387 trials) and over 65 (1023 trials)."

Answered by AI

Could you give me a ballpark number of people enrolling in this research project?

"The information on clinicaltrials.gov affirms that this study is open for enrollment and is currently looking for 36 patients at a single location. The study was first posted on September 1, 2022 and updated on September 27, 2022."

Answered by AI
~14 spots leftby Apr 2025