Blood Flow Regulation in Individuals With Down Syndrome - Training Study

NCT04854122 | Completed Results

• 2 other identifiers: UNLV_BFDS_TrainingStudy4R00HD092606-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Down Syndrome

Keywords

exercise; blood flow regulation; blood pressure; heart rate

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Work Capacity at 13 Weeks

  Change in work capacity from baseline to 13 weeks, as measured by peak oxygen uptake in ml/kg/min with a graded exercise test on a treadmill.

  13 weeks

Secondary Outcomes (13)

• Change From Baseline Brachial Blood Flow at 13 Weeks

  13 weeks

• Change From Baseline Muscle Oxygenation at 13 Weeks

  13 weeks

• Change From Baseline Cardiac Output (Aortic Blood Flow) at 13 Weeks

  13 weeks

• Change From Baseline Autonomic Cardiac Function at Rest at 13 Weeks

  13 weeks

• Change From Baseline Autonomic Cardiac Function During Orthostasis at 13 Weeks

  13 weeks

Other Outcomes (4)

• Change From Baseline C-Reactive Protein at 13 Weeks

  13 weeks

• Change From Baseline Tumor Necrosis Factor - Alpha at 13 Weeks

  13 weeks

• Change From Baseline Glucose at 13 Weeks

  13 weeks

Study Arms (3)

Combined exercise intervention Down syndrome

EXPERIMENTAL

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.

Behavioral: Combined exercise intervention

Usual care Down Syndrome

SHAM COMPARATOR

The control condition consists of usual activities.

Behavioral: Usual care / Sham intervention

Reference group without Down syndrome

NO 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.

Interventions

Combined exercise intervention 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. Aerobic exercise will be part of all three sessions, with resistance exercise during two out of three sessions. Training sessions will be supervised by personal trainers to ensure the safe use of the equipment and the correct form when performing each exercise. The first 3 weeks of the intervention will be familiarization with the exercises and the program. After a warm-up, the participant will perform 30 min of aerobic exercise at a heart rate of 65% of the participant's maximum heart rate \[43\], which increases to 65-85% during weeks 4-12 of the intervention. The resistance exercise part will include all major muscle groups, both upper and lower body.

Combined exercise intervention Down syndrome

Usual care / Sham intervention BEHAVIORAL

The control condition consists of usual activities.

Usual care Down Syndrome

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

Location

MeSH Terms

Conditions

Down Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Behavior

Results Point of Contact

• Title: Thessa Hilgenkamp
• Organization: University of Nevada, Las Vegas

thessa.hilgenkamp@unlv.edu

702-895-1055

Study Officials

• Thessa Hilgenkamp, PhD

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As this is an exercise intervention, both the study team and the participant will be aware of which group the participant is assigned to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This intervention study will be set up as a randomized controlled trial comparing the effects of a 12-weeks exercise program to 12-weeks of non-exercise usual care in participants with Down syndrome.

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: April 22, 2021
• Study Start: September 9, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)