N/A N=60 Randomized Supportive Care

Blood Flow Regulation in Individuals With Down Syndrome - Training Study

Down Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT04854122 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2026

Primary outcome: Primary: Change From Baseline Work Capacity at 13 Weeks — -1.20; -0.18 change in ml/kg/min — p=0.660

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Combined exercise intervention (Behavioral); Usual care / Sham intervention (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Nevada, Las Vegas
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline Work Capacity at 13 Weeks	-1.20; -0.18	0.660
SECONDARY Change From Baseline Brachial Blood Flow at 13 Weeks	24.66; -15.87	0.196
SECONDARY Change From Baseline Muscle Oxygenation at 13 Weeks	-5.27; 0.49	0.256
SECONDARY Change From Baseline Cardiac Output (Aortic Blood Flow) at 13 Weeks	4.26; 0.84	—
SECONDARY Change From Baseline Autonomic Cardiac Function at Rest at 13 Weeks	-7.40; 3.71	0.198
SECONDARY Change From Baseline Autonomic Cardiac Function During Orthostasis at 13 Weeks	20.33; -4.43	0.043 sig
SECONDARY Change From Baseline IL-6 at 13 Weeks	-0.75; 3.28	0.174
SECONDARY Change From Baseline HDL at 13 Weeks	-3.67; -2.31	0.707
SECONDARY Change From Baseline Superoxide Dismutase at 13 Weeks	-0.5510; -0.1576	0.571
SECONDARY Change From Baseline Comfortable Walking Speed at 13 Weeks	5.49; 1.27	0.559
SECONDARY Change From Baseline Fast Walking Speed at 13 Weeks	6.96; -1.93	0.306
SECONDARY Change From Baseline Functional Reach at 13 Weeks	-0.82; 0.17	0.287
SECONDARY Change From Baseline Timed Up and Go at 13 Weeks	-0.59; -0.34	0.725
SECONDARY Change From Baseline Standing Balance at 13 Weeks	1.11; -3.39	0.163

Summary

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

Inclusion Criteria

generally healthy
sedentary (defined as being involved in less than 30 minutes of moderately-intense physical activity per day)
additionally for the participants with Down syndrome:
diagnosis of Down syndrome trisomy 21 and
normal thyroid function or stable thyroid function (and medications) for at least 6 mo.

Exclusion Criteria

congenital heart disease;
atherosclerotic or other vascular disease;
asthma or other pulmonary disease;
hypertension (defined BP >140/90 mmHg);
blood pressure below 90/60 mmHg;
history of pre-syncope or syncope;
diabetes (defined as Hba1c of >7.5% or use of glucose lowering medication);
severe obesity (defined as BMI >40);
medications affecting heart rate, blood pressure or arterial function;
anti-inflammatory medication including NSAIDS;
current smoking and
pregnancy.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04854122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.