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Exercise Intervention for Down Syndrome

N/A

Recruiting

Led By Thessa Hilgenkamp, PhD

Research Sponsored by University of Nevada, Las Vegas

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

Must not have

Diabetes (defined as Hba1c of >7.5% or use of glucose lowering medication)

Atherosclerotic or other vascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 13 weeks

Summary

This trial looks at the effects of exercise on people with Down Syndrome, specifically how it affects blood flow and cardiac function. They also want to see how exercise affects balance, walking, and attitude.

Who is the study for?

This trial is for generally healthy, sedentary adults with Down syndrome who have normal or stable thyroid function. It's not open to those with heart disease, vascular issues, severe lung conditions, uncontrolled blood pressure, a history of fainting episodes, diabetes, extreme obesity, or those on certain medications affecting the heart and arteries.

What is being tested?

The study is testing how well people with Down syndrome respond to exercise training in terms of blood flow regulation and cardiac function. Participants will either receive combined exercise interventions or usual care to see if there are improvements in their peak oxygen consumption.

What are the potential side effects?

While specific side effects aren't listed for this trial since it involves exercise intervention rather than medication, typical risks might include muscle soreness or injury from physical activity.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes with an HbA1c over 7.5% or I am on medication to lower my blood sugar.

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I have a condition related to hardening of the arteries.

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I am currently taking anti-inflammatory medication.

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I have a history of fainting or nearly fainting.

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I was born with a heart condition.

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I am not on medications that affect my heart rate, blood pressure, or arteries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline Work capacity at 13 weeks

Secondary study objectives

Change from Baseline Autonomic cardiac function at rest at 13 weeks

Change from Baseline Autonomic cardiac function during orthostasis at 13 weeks

Change from Baseline Brachial blood flow at 13 weeks

+12 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Combined exercise intervention Down syndromeExperimental Treatment1 Intervention

The exercise intervention will last 12 weeks and will consist of a supervised combined aerobic and resistance training program with a frequency of 3 days/week.In the exercise sessions, the participant will work with the trainer on their strength, balance and aerobic endurance. Each session consists of 10 min of strength exercises (Foundational Exercise), 10 min of Hip Strengthening, 10 min of Vestibular and Balance Exercise, and 20 min of Aerobic Exercise, and starts with a warming up and ends with stretching/cooling down. Each new exercise will be introduced in easy steps and practiced until the participant is comfortable executing it.

Group II: Reference group without Down syndromeActive Control1 Intervention

This reference group of age- and sex-matched inactive individuals without Down syndrome will undergo the same baseline testing as the other groups but without intervention or post-intervention measures.

Group III: Usual care Down SyndromePlacebo Group1 Intervention

The control condition consists of usual activities.

0 / 6Eligibility criteria met