Combined exercise intervention for Down Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Nevada, Las Vegas, Las Vegas, NV
Down Syndrome+1 More
Combined exercise intervention - Behavioral
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

Blood Flow Regulation in Individuals With Down Syndrome - Training Study

See full description

Eligible Conditions

  • Down Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Combined exercise intervention will improve 1 primary outcome and 15 secondary outcomes in patients with Down Syndrome. Measurement will happen over the course of 13 weeks.

13 weeks
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
Change from Baseline Cardiac output (Aortic blood flow) at 13 weeks
Change from Baseline Catecholamines at 13 weeks
Change from Baseline Functional Reach at 13 weeks
Change from Baseline Gait at 13 weeks
Change from Baseline Inflammatory markers at 13 weeks
Change from Baseline Metabolic markers at 13 weeks
Change from Baseline Muscle oxygenation at 13 weeks
Change from Baseline Oxidative stress markers at 13 weeks
Change from Baseline Standing Balance at 13 weeks
Change from Baseline Thyroid function at 13 weeks
Change from Baseline Timed Up and Go at 13 weeks
Change from Baseline Walking speed at 13 weeks
Change from Baseline Work capacity at 13 weeks

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Reference group without Down syndrome
1 of 3
Combined exercise intervention Down syndrome
1 of 3
Usual care Down Syndrome
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

This trial requires 60 total participants across 3 different treatment groups

This trial involves 3 different treatments. Combined Exercise Intervention is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Combined exercise intervention Down syndrome
Behavioral
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.
Usual care Down Syndrome
Behavioral
The control condition consists of usual activities.
Reference group without Down syndromeThis 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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 13 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 13 weeks for reporting.

Closest Location

University of Nevada, Las Vegas - Las Vegas, NV

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
generally healthy
sedentary (defined as being involved in less than 30 minutes of moderately-intense physical activity per day)
diagnosis of Down syndrome trisomy 21
normal thyroid function or stable thyroid function (and medications) for at least 6 mo.

Patient Q&A Section

Can syndrome be cured?

"It seems that the occurrence of certain syndromes is inevitable. One may try to prevent, reduce, and/or cure them, but it will be impossible to cure them completely." - Anonymous Online Contributor

Unverified Answer

How many people get syndrome a year in the United States?

"Every year, 1 in every 17 persons (2.6%) is diagnosed with 1 of the 14 syndromes on the list. By comparison, 1 in every 18 persons (0.5%) is diagnosed with Alzheimer's disease and 1 of every 100 persons (0.01%) is diagnosed with multiple myeloma. The incidence of these syndromes, especially multiple myeloma, is rising slightly." - Anonymous Online Contributor

Unverified Answer

What is syndrome?

"Syndromes are groups of diseases whose cause and effect is not easily explained by the disease being the cause, the disease being the effect and by no other reason. In most medical conditions where a cause-effect equation is sought the cause is not known, and the effect. Syndromes often have a combination of known or unknown causes. For example, many metabolic conditions are regarded as symptomatic of other more specific genetic abnormalities or environmental risk factors.\n\nThere are a wide variety of syndromes, the largest of which are those characterized by defects in one or more systems, particularly of development, function and regulation." - Anonymous Online Contributor

Unverified Answer

What are the signs of syndrome?

"There is substantial overlap among the signs and symptoms of the syndromes that can be seen in young and middle-aged adults, and can range from mild to severe. It therefore appears that clinicians must routinely look for all of the syndromes in young patients to ensure early recognition." - Anonymous Online Contributor

Unverified Answer

What causes syndrome?

"There is no definitive definition of what constitutes an syndrome. Syndromal personality disorder can be considered as a syndrome or sub-group within the psychiatric nosology, and some sub-groups could be considered as syndromes in certain individuals. Other sub-groups of syndromes or sub-groups based on diagnostic, prognostic and treatment concepts are suggested in the following article." - Anonymous Online Contributor

Unverified Answer

What are common treatments for syndrome?

"Syndromes are frequently treated with pharmacotherapy, and psychotherapy and psychosocial support may be helpful. Although there is no evidence that the syndrome affects outcomes following intervention, many patients reported benefits." - Anonymous Online Contributor

Unverified Answer

Is combined exercise intervention typically used in combination with any other treatments?

"Only 4% of the studies in this review reported that the intervention was combined with some type of treatment (such as medication). However, the level of evidence regarding the effects of such treatments is limited because the reporting in the included studies is too poor." - Anonymous Online Contributor

Unverified Answer

How serious can syndrome be?

"In the absence of an alternative explanation, we believe the syndrome is very likely to pose a significant long-term threat to health and/or a significant contribution to death. This may happen more often than commonly realized. The syndrome is most serious when it affects multiple people at once." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for syndrome?

"Clinical trials may be a good option for patients with an undefined medical condition and a specific syndrome after [assessing the syndrome to help determine appropriate therapies]. Clinical trials of an undefined disease may be the only option for patients with syndrome in which treatment is not yet available. There are [randomized trials that use standardized criteria to assess the syndrome for enrollment in various clinical trials that evaluate treatment options for this condition. If you are looking for such a trial, use<nowiki>[</nowiki>https://www.clinicaltrials.gov/ (http://www.clinicaltrials.gov/)</nowiki> to gain a greater insight of current trials and their participants." - Anonymous Online Contributor

Unverified Answer

Has combined exercise intervention proven to be more effective than a placebo?

"Findings from a recent study of the combined exercise intervention provided by physical therapists were favorable and should be more intensive than physical therapy only, especially for the prevention of fall-related injuries." - Anonymous Online Contributor

Unverified Answer

What is the latest research for syndrome?

"If you're in search for the latest research of syndrome, use [PubMed]. All research on syndrome are in full text, and all the latest research findings can be found here." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating syndrome?

"Syndrome is a long-lasting distress that can affect the brain. Drugs do not cure the disorder yet, but they can improve the effects of the brain. Future research directions include finding ways to diagnose syndrome while improving treatment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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