CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
Pedalling exercise on a cycle ergometer +1 morebiological
Likely dose
Not stated in record
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Search/NCT02854280
NCT02854280N/ACompleted

Brain During Effort : Effects of Hypoxia With Respiratory Patients

University Hospital, Grenoble·interventional·Posted Aug 3, 2016·Updated Mar 7, 2018

In Brief

A clinical study evaluating Pedalling exercise on a cycle ergometer and Isolated contractions of the quadriceps for Chronic Obstructive Pulmonary Disease (COPD) and 2 related conditions. Completed, enrolled 33 participants across 1 site.

Detailed Summary

Brain oxygenation is determined by the product of CaO2 and the cerebral blood flow (CBF), the modification of one or the other can affect the neuronal O2 availability. Besides the effect of the PaO2, the CBF is also regulated by the PaCO2. During effort in state of hypoxia, the drop of the PaO2 associated to a potential decrease of the PaCO2 and therefore of the CBF, can create an important dizziness between the demand and the supply of cerebral O2. It seems that hypoxia can trouble in a significant way the response of central neurons, just as the production of a motor cortex generated motor command. Studies suggest that exercise in severe hypoxia condition can constitute a necessary threat for brain oxygenation and the motor command, with the consequence a decrease of the exercise performance. This projects aim to study effects of hypoxia on the brain function for patients suffering from chronic respiratory disease. Neurophysiologic responses of the brain while resting or exercising, including drip and cerebral oxygenation, cortical excitation and motor command resulting for hypoxic subjects before and after a treatment to correct abnormalities of gaz in blood. The study will use a multidisciplinary and supplementary methodological approach : the near-infrared spectroscopy (NIRS) to appreciate the drip and cerebral oxygenation, CBF, neurostimulation procedures and electromyography (EMG) to appreciate the cortical excitability, measure the level of central activation and motor command. The goals of this study will be : * Measure the drip and cerebral oxygenation, the cortical excitability, mechanisms of voluntary activation and central fatigue to the effort for the chronic hypoxemic patient compared to healthy control subjects. * Analyse disruptions of locomotion parameters and posturographyc, in simple and double task, involving different levels of cerebral task. * Analyse acute effects of an improvement of arterial oxygenation for patients suffering from chronic obstructive pulmonary disease (COPD) on drip and cerebral oxygenation, cortical excitability, mechanisms of voluntary activation and central fatigue. * Evaluate effects of a treatment by continuous positive airway pressure (CPAP) for patients suffering from obstructive sleep apnea (OSA) with the same parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 3, 2016
Enrollment StartJun 1, 2013
Primary CompletionApr 1, 2016
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.9 years ago

Interventions

Pedalling exercise on a cycle ergometerbiological

At 80% of the maximal aerobic power, until exhaustion

Isolated contractions of the quadricepsbiological

Until exhaustion