Blood Flow Regulation in Individuals With Down Syndrome - Training Study

NCT04854122 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-04

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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

Interventions

BEHAVIORAL

Combined exercise 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. 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.

BEHAVIORAL

Usual care / Sham intervention

The control condition consists of usual activities.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • University of Nevada, Las Vegas

    lead OTHER

Principal Investigators

  • Thessa Hilgenkamp, PhD · University of Nevada, Las Vegas

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04854122 on ClinicalTrials.gov