Clinical trial NCT04045444: Cerebral Oxygenation During Gait in Elderly
Official title: Physical Activity Level and Cerebral Oxygenation During Gait in Old People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Oxygenation
Keywords: physical activity
cognitive function
elderly
parkinson
muscle oxygenation
gait parameters
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Ageing is accompanied by a cognitive decline altering gait and increasing the risk of falling. Physical activity could reduce this cognitive decline by an improvement in the oxygen supply to the brain. At the moment, the effect of physical activity on brain oxygenation during walking in elderly has never been described. Moreover, the increase in cognitive request during a dual task could lead to an increase in the risk of falling. In this context, the investigators of Orleans's hospital want to examine the effect of the physical activity level of elderly on their brain oxygenation during walking and during a dual task.

Moreover, Parkinson' patients could display an impairment of gait and cognitive function. Attentional task and dual task situation are particularly impaired in this pathology. This is why the investigators of Orleans's hospital want to also examine cerebral activation of these patients during walking and during a dual task.

The hemodynamic cerebral activation will be studied using the near infrared spectroscopy at the level of the prefrontal cortex. This non-invasive technic allows the evaluation of the regional oxyhemoglobin and deoxyhemoglobin variations induced by cerebral activation.

Detailed description: The main aim of the study is to determine the effect of the physical activity level on variations of the pre-frontal oxygenation during walking and during a dual task in elderly. The other aims are to study the effects of age, gender and the Parkinson' disease on variations of the pre-frontal oxygenation during walking and during a dual task in elderly.

For that, 160 participants (females and males) will be included and 8 groups will be constituted (woman and man non active young people, woman and man non active old people, woman and man active old people, woman and man patients with Parkinson's disease).

Every participants will performed a set of 6 tasks of 2 minutes. Each task will be separated by a 2 minutes resting period. The tasks will be a cognitive task, a control cognitive task, walking at 3 kilometers/hour, walking while doing the cognitive task, walking at the preferred speed, walking at the preferred speed while doing the cognitive task.

During the set, prefrontal oxygenation will be measured using the near infrared spectroscopy.

Eligibility criteria: Inclusion Criteria:

* men and women non active young people and men and women non active old people : practice less than one hour of physical activity per week
* men and women active old people: practice at least 3 hours of physical activity per week

Non-Inclusion Criteria :

For all subjects:

* Resting electrocardiographic abnormality, Systolic blood pressure \>16
* Heart disease, recent and unusual shortness of breath or needing several pillows to sleep at night, effort/rest chest pain, palpitations with effort, history of discomfort with effort
* Respiratory failure
* Disabling rheumatological pathology for walking
* Neuro-progressive disease or sequelae
* Perceptual disorders
* Medication (neuroleptics, psychotropic treatment modifying alertness) potentially having an impact on walking
* Thickness of the skin fold at the vast lateral area greater than 15 mm
* Inability of the volunteer to perform the Random Generation of Numbers task for at least 1 min or frequency of enunciation numbers during the Random Generation of Numbers task \> 4/s
* Refusal to sign informed consent

For the young sedentary group (woman and man) and the senior group (woman and man, sedentary and active):

-Subjective health \> 3 out of 5

For the senior group (woman and man, sedentary and active):

* Mini-Mental State Evaluation (MMSE) score \< 24
* Geriatric Depression Scale (GDS) score \> 10

For the Parkinson group (woman and man):

* Presence of a freezing or clinically embarrassing festination (walking disorder)
* Score of Hoehn and Yahr ≥III

Exclusion Criteria:

-Inability of the volunteer to walk on the treadmill at a speed of 3 km/h without assistance (stand at the helm or ask for help)

Primary outcomes:
measure: concentration of cerebral oxyhemoglobin
timeFrame: day 1
measure: concentration of cerebral deoxyhemoglobin
timeFrame: day 1
Secondary outcomes:
measure: concentration of muscular oxyhemoglobin
timeFrame: day 1
measure: concentration of muscular deoxyhemoglobin
timeFrame: day 1
measure: measurement of cognitive performance using random number generation task
timeFrame: day 1
measure: cardiac frequency
timeFrame: day 1
measure: Step width: distance between the middle support point of each foot with optogait system
timeFrame: day 1
measure: Scale of perceived difficulties for perception of effort
timeFrame: day 1
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR Orléans
Study officials:
affiliation: CHR orléans
name: Pascal AUZOU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderton BH. Ageing of the brain. Mech Ageing Dev. 2002 Apr;123(7):811-7. doi: 10.1016/s0047-6374(01)00426-2.
citation: Andres P, Van der Linden M. Age-related differences in supervisory attentional system functions. J Gerontol B Psychol Sci Soc Sci. 2000 Nov;55(6):P373-80. doi: 10.1093/geronb/55.6.p373.
citation: Asllani I, Habeck C, Borogovac A, Brown TR, Brickman AM, Stern Y. Separating function from structure in perfusion imaging of the aging brain. Hum Brain Mapp. 2009 Sep;30(9):2927-35. doi: 10.1002/hbm.20719.
citation: Azulay JP, Van Den Brand C, Mestre D, Blin O, Sangla I, Pouget J, Serratrice G. [Automatic motion analysis of gait in patients with Parkinson disease: effects of levodopa and visual stimulations]. Rev Neurol (Paris). 1996 Feb;152(2):128-34. French.