Exercise Intervention for Down Syndrome

Recruiting in Palo Alto (17 mi)

Overseen byThessa Hilgenkamp, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Nevada, Las Vegas

No Placebo Group

Trial Summary

What is the purpose of this trial?Work capacity is an important predictor of declining health or physical function, and of mortality, and is commonly measured as peak oxygen consumption. Peak oxygen consumption is very low in individuals with Down syndrome, the most prevalent genetic cause of intellectual disability. Previous research suggests individuals with Down syndrome may experience a double disadvantage when they are exercising: they may not be able to increase cardiac output sufficiently and they may not be able to allocate adequate blood flow to the working muscles. The aim of this research proposal is therefore to investigate the responses in central and peripheral blood flow regulation and cardiac autonomic function to exercise training in individuals with DS. Additionally the effects of exercise on gait, balance and attitude towards exercise in individuals with DS are investigated.

Eligibility Criteria

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.

Inclusion Criteria

I have Down syndrome with normal or stable thyroid function for at least 6 months.

I do less than 30 minutes of moderate exercise daily.

Generally healthy

Exclusion Criteria

You have high blood pressure (defined as blood pressure higher than 140/90 mmHg).

You are extremely overweight with a body mass index (BMI) over 40.

Your blood pressure is lower than 90/60 mmHg.

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Participant Groups

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.

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.