NCT05995223

Brief Summary

This study aims to compare the rate at which oxygen uptake adapts to submaximal, moderate intensity exercise (oxygen uptake kinetics) between adults with and without Down syndrome, to determine the contribution of oxygen uptake kinetics to exercise intolerance of adults with Down syndrome. Additionally, the study will investigate the role of oxygen delivery (by the cardiovascular circuit) and oxygen utilization (in the mitochondria) on the oxygen uptake kinetics of adults with Down syndrome to identify specific areas which adults with Down syndrome could benefit from targeting during exercise training. Overall, this study aims to contribute to the knowledge on the exercise capacity of adults with Down syndrome, in order to improve the way adults with Down syndrome participate in and benefit from exercise. Participants will perform a maximal exercise test on a treadmill, and walk on a treadmill at a submaximal, moderate intensity speed and incline, during which oxygen uptake at the lungs, cardiac output, and oxygen utilization in the muscle will be measured.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 4, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

June 29, 2023

Last Update Submit

June 27, 2024

Conditions

Keywords

Down syndromecardiorespiratory fitnessoxygen uptakecardiac outputmitochondrial oxygen utilization

Outcome Measures

Primary Outcomes (1)

  • Oxygen uptake kinetics

    The finite rate at which oxygen uptake (measured with breath-by-breath gas exchange analysis at the mouth) adapts to a (submaximal) increase in exercise intensity, primarily captured by time constant tau, which describes the time needed to reach 63% of the required, steady state oxygen uptake

    Through study completion, on average 4 hours

Secondary Outcomes (13)

  • Cardiac output kinetics

    Through study completion, on average 4 hours

  • Muscle deoxygenation kinetics

    Through study completion, on average 4 hours

  • Steady-state cardiac output

    Through study completion, on average 4 hours

  • Absolute peak oxygen uptake

    Through study completion, on average 4 hours

  • Relative peak oxygen uptake (corrected for total body mass)

    Through study completion, on average 4 hours

  • +8 more secondary outcomes

Study Arms (2)

Down syndrome

EXPERIMENTAL

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.

Other: Submaximal exercise protocol

control without Down syndrome

EXPERIMENTAL

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

Other: Submaximal exercise protocol

Interventions

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.

Down syndromecontrol without Down syndrome

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • low active (defined as being involved in less than 30 minutes of moderately-intense physical activity per day);
  • diagnosis with Down syndrome trisomy 21 (Down syndrome group only);
  • normal thyroid function or stable thyroid function (with medications) for at least 6 months (Down syndrome group only).

You may not qualify if:

  • asthma or other pulmonary disease;
  • severe obesity (defined as BMI \>40);
  • uncontrolled hypertension (defined as blood pressure \>130/80 mmHg);
  • congenital heart disease;
  • diabetes (defined as Hba1c of \>7.5% or use of glucose lowering medication);
  • current smoking;
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Victor DY Beck, MS

    University of Nevada, Las Vegas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Research Assistant

Study Record Dates

First Submitted

June 29, 2023

First Posted

August 16, 2023

Study Start

October 4, 2023

Primary Completion

June 27, 2024

Study Completion

June 27, 2024

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

De-identified IPD will be made available to other researchers upon request.

Locations