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Exercise for Down Syndrome (FBI21 Trial)
FBI21 Trial Summary
This trial will help to elucidate why people with Down Syndrome have reduced work capacity, and how this can be improved.
- Down Syndrome
FBI21 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FBI21 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Dynamic Exercise
- Group 2: Static Exercise
- 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.
- 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.
Frequently Asked Questions
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."
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."
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."
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)."
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."
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