Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT03029559
Brief Summary:
Rehabilitation approaches introduce a stimulus to a motor system, with the goal to enhance motor function to patients. For example, exposure to brief and intermittent episodes of mild hypoxia has shown to strengthen synaptic pathways to respiratory and skeletal muscle motor neurons. In humans with spinal cord injury, exposure to intermittent hypoxia (IH) alone or in combination with rehabilitative strategies has shown enhanced motor function. Another strategy known as inspiratory threshold loading, which involves breathing against pressure threshold loads, results in improved inspiratory muscle strength. Although there is evidence supporting the use of IH alone or in combination with other rehabilitative strategies in improving motor function in humans, the impact of exposure to IH or IH with inspiratory threshold loading on inspiratory muscle function and ventilation in humans is unknown.
Detailed Description:
Investigators will test whether exposure to IH alone and in combination with inspiratory threshold loading (ITL) will result in increased inspiratory muscle strength and ventilation.
Investigators will use a Latin square, repeated measures design which will consist of 12 subjects participating in four experimental conditions.There will be an interval of 1 week between each of the four conditions, which will serve as a washout period.
At the end of each of the 5 sessions, the subjects will rest in a reclining chair for 15 minutes while their heart rate, blood pressure, oxygen saturation and breathing are monitored. Subjects that have a blood systolic blood pressure \> 140 or diastolic pressure \> 90 or SPO2 \< 92% will be asked to remain in the laboratory for 15 additional minutes and the vital signs will be repeated. If the blood pressure and/or peripheral capillary oxygen saturation (SPO2) remain outside of the criteria mentioned above, the subject will be instructed to seek assessment by their health provider and the incident will be reported to the Institutional Review Board. Subjects will also be asked to report any discomfort.
Study:
NCT03029559
Study Brief:
Protocol Section:
NCT03029559