Oxygen Uptake Kinetics During Submaximal Exercise in Adults With Down Syndrome
1 other identifier
interventional
28
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
August 16, 2023
CompletedStudy Start
First participant enrolled
October 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2024
CompletedJuly 1, 2024
June 1, 2024
9 months
June 29, 2023
June 27, 2024
Conditions
Keywords
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
EXPERIMENTALParticipants 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.
control without Down syndrome
EXPERIMENTALThis group of age- and sex-matched participants without Down syndrome will undergo the same testing as participants with Down syndrome
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victor DY Beck, MS
University of Nevada, Las Vegas
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.