Oxygen Uptake Kinetics During Submaximal Exercise in Adults With Down Syndrome
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ClinicalTrials.gov Identifier: NCT05995223 |
Recruitment Status :
Recruiting
First Posted : August 16, 2023
Last Update Posted : November 28, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
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Down Syndrome | Other: Submaximal exercise protocol | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Oxygen Uptake Kinetics During Submaximal Exercise in Adults With Down Syndrome |
Actual Study Start Date : | October 4, 2023 |
Estimated Primary Completion Date : | July 2024 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Down syndrome
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.
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Other: Submaximal exercise protocol
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. |
Experimental: control without Down syndrome
This group of age- and sex-matched participants without Down syndrome will undergo the same testing as participants with Down syndrome
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Other: Submaximal exercise protocol
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. |
- Oxygen uptake kinetics [ Time Frame: Through study completion, on average 4 hours ]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
- Cardiac output kinetics [ Time Frame: Through study completion, on average 4 hours ]The finite rate at which cardiac output (calculated from beat-to-beat blood pressure waves) 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 cardiac output
- Muscle deoxygenation kinetics [ Time Frame: Through study completion, on average 4 hours ]The finite rate at which muscle oxygen utilization (measured as the production of deoxyhemoglobin at the muscle) 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 muscle oxygen utilization
- Steady-state cardiac output [ Time Frame: Through study completion, on average 4 hours ]Steady state cardiac output during standing rest and submaximal exercise (in L/min)
- Absolute peak oxygen uptake [ Time Frame: Through study completion, on average 4 hours ]Peak oxygen uptake (VO2peak; expressed in L/min)
- Relative peak oxygen uptake (corrected for total body mass) [ Time Frame: Through study completion, on average 4 hours ]Peak oxygen uptake (VO2peak; expressed in ml/kg/min)
- Relative peak oxygen uptake (corrected for lean body mass) [ Time Frame: Through study completion, on average 4 hours ]Peak oxygen uptake (VO2peak; expressed in L=mL/kg lean body mass/min)
- Ventilatory threshold (L/min) [ Time Frame: Through study completion, on average 4 hours ]The threshold where ventilation starts to increase at a faster rate than oxygen uptake during a graded maximal exercise test (expressed in L/min)
- Ventilatory threshold (%VO2peak) [ Time Frame: Through study completion, on average 4 hours ]The threshold where ventilation starts to increase at a faster rate than oxygen uptake during a graded maximal exercise test (expressed as a percentage of VO2peak)
- Stroke volume [ Time Frame: Through study completion, on average 4 hours ]Stroke volume (mL)
- Heart rate [ Time Frame: Through study completion, on average 4 hours ]Heart rate (in bpm)
- Oxygen uptake efficiency slope [ Time Frame: Through study completion, on average 4 hours ]The slope between oxygen uptake (L/min) and the common logarithm of minute ventilation (L/min) during a graded maximal exercise test
- Ve/VCO2 slope [ Time Frame: Through study completion, on average 4 hours ]The slope between minute ventilation (Ve; L/min) and carbon dioxide production (VCO2; L/min) during a graded maximal exercise test
- Lean body mass [ Time Frame: Through study completion, on average 4 hours ]Lean body mass determined with Dual Energy X-ray Absorptiometry (DXA) scan in kg
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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05995223
Contact: Victor DY Beck, MS | 702-895-3003 | victor.beck@unlv.edu | |
Contact: Thessa IM Hilgenkamp, PhD | 702-895-3003 | thessa.hilgenkamp@unlv.edu |
United States, Nevada | |
University of Nevada, Las Vegas | Recruiting |
Las Vegas, Nevada, United States, 89154 | |
Contact: Victor DY Beck, MS 702-895-3003 victor.beck@unlv.edu |
Principal Investigator: | Victor DY Beck, MS | University of Nevada, Las Vegas |
Responsible Party: | Victor Beck, Graduate Research Assistant, University of Nevada, Las Vegas |
ClinicalTrials.gov Identifier: | NCT05995223 |
Other Study ID Numbers: |
UNLV-2022-489 |
First Posted: | August 16, 2023 Key Record Dates |
Last Update Posted: | November 28, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | De-identified IPD will be made available to other researchers upon request. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Down syndrome cardiorespiratory fitness oxygen uptake cardiac output mitochondrial oxygen utilization |
Down Syndrome Syndrome Disease Pathologic Processes Intellectual Disability Neurobehavioral Manifestations |
Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn |