What is the mechanism of action of this treatment?

Common treatments for Down Syndrome, particularly those focusing on exercise training, aim to improve cardiovascular and muscular function. Exercise training enhances oxygen uptake kinetics by improving the efficiency of oxygen delivery and utilization in the body. This is crucial for Down Syndrome patients as they often experience reduced exercise capacity and higher rates of cardiovascular issues. By improving oxygen uptake, exercise training can help mitigate these challenges, leading to better overall health and quality of life.

What side effects are associated with this type of intervention?

Exercise training, particularly aimed at improving oxygen uptake kinetics, is a common intervention for adults with Down Syndrome to enhance their exercise capacity. Generally, exercise training is well-tolerated, but potential side effects can include muscle soreness, fatigue, and, in rare cases, overuse injuries such as strains or sprains. It is important to tailor exercise programs to individual capabilities and monitor for any adverse effects to ensure safety and effectiveness.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Down Syndrome mentioned in the provided context. The trial focuses on improving exercise capacity and oxygen uptake kinetics in adults with Down Syndrome, but no specific drugs or treatments for this purpose are detailed. Generally, treatments for Down Syndrome may include therapies and interventions to manage associated health conditions, but specific pharmacological treatments targeting exercise capacity or oxygen uptake kinetics are not highlighted.

What other types of research exist?

Promising novel alternatives to exercise training for improving oxygen uptake kinetics in Down Syndrome patients include: 1) Pharmacological interventions targeting mitochondrial function and cardiovascular health, such as Coenzyme Q10 and L-carnitine supplements. 2) Non-invasive neuromodulation techniques like transcranial direct current stimulation (tDCS) to enhance neural control of cardiovascular function. 3) Advanced respiratory therapies, including high-frequency chest wall oscillation to improve pulmonary function and oxygen delivery.

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Submaximal Exercise Protocol for Down Syndrome

N/A

Waitlist Available

Led By Victor DY Beck, MS

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

Diagnosis with Down syndrome trisomy 21 (Down syndrome group only)

Be between 18 and 65 years old

Must not have

Severe obesity (defined as BMI >40)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, on average 4 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial involves adults with Down syndrome performing treadmill exercises while researchers measure how their bodies use oxygen. The goal is to understand why people with Down syndrome have lower fitness levels and to find ways to improve their exercise routines. By studying how quickly their bodies adapt to exercise, researchers hope to design better exercise programs for them.

Who is the study for?

This trial is for low-active adults with Down syndrome, meaning they engage in less than 30 minutes of moderate exercise daily. They must have normal or stable thyroid function. It's not open to those with severe obesity, uncontrolled high blood pressure, heart disease, diabetes, current smokers, or pregnant individuals.

What is being tested?

The study tests how quickly adults with Down syndrome adjust their oxygen uptake during moderate treadmill exercise compared to those without the condition. It measures lung oxygen uptake, cardiac output and muscle oxygen use to improve understanding of their exercise capacity.

What are the potential side effects?

Since this trial involves a submaximal exercise protocol on a treadmill rather than medication or invasive procedures, side effects are minimal but may include typical exercise-related responses such as shortness of breath or muscle fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Down syndrome.

Exclusion Criteria

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

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My BMI is over 40, indicating severe obesity.

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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 was born with a heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, on average 4 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, on average 4 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, on average 4 hours for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Oxygen uptake kinetics

Secondary study objectives

Absolute peak oxygen uptake

Cardiac output kinetics

Heart rate

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: control without Down syndromeExperimental Treatment1 Intervention

This group of age- and sex-matched participants without Down syndrome will undergo the same testing as participants with Down syndrome

Group II: Down syndromeExperimental Treatment1 Intervention

Participants will complete a submaximal walking protocol on a motorized treadmill, which consists of 4 times 6 minutes of walking at a moderate intensity speed and incline while their breathing, cardiac output, and muscle oxygen use is measured, with 10 minutes rest in between each bout.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Down Syndrome, particularly those focusing on exercise training, aim to improve cardiovascular and muscular function. Exercise training enhances oxygen uptake kinetics by improving the efficiency of oxygen delivery and utilization in the body. This is crucial for Down Syndrome patients as they often experience reduced exercise capacity and higher rates of cardiovascular issues. By improving oxygen uptake, exercise training can help mitigate these challenges, leading to better overall health and quality of life.

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