Cerebral Oxygenation During Gait in Elderly

Not Applicable

Completed

• Conditions: Cerebral Oxygenation
• Interventions: Other: walking; Other: cognitive task

• Registration Number: NCT04045444
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

Study Timeline

• Study First Submitted: 2019-02-21
• Study Start: 2019-02-25
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-05
• Primary Completion: 2021-04-20
• Study Completion: 2021-04-20
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
women non active young people	walking	women between 18 and 30 years practice less than 1h of physical activity per week
women non active old people	cognitive task	women between 60 and 85 years practice less than 1h of physical activity per week
men non active young people	cognitive task	men between 18 and 30 years practice less than 1h of physical activity per week
men non active old people	cognitive task	men between 60 and 85 years practice less than 1h of physical activity per week
men active old people	cognitive task	men between 60 and 85 years practice at least 3h of physical activity per week
men with parkinson's disease	walking	men between 60 and 85 years presence of the disease according to the criteria of the UK Parkinson Disease Brain Bank
men non active young people	walking	men between 18 and 30 years practice less than 1h of physical activity per week
men with parkinson's disease	cognitive task	men between 60 and 85 years presence of the disease according to the criteria of the UK Parkinson Disease Brain Bank
women non active young people	cognitive task	women between 18 and 30 years practice less than 1h of physical activity per week
women non active old people	walking	women between 60 and 85 years practice less than 1h of physical activity per week
men non active old people	walking	men between 60 and 85 years practice less than 1h of physical activity per week
women active old people	cognitive task	women between 60 and 85 years practice at least 3h of physical activity per week
women active old people	walking	women between 60 and 85 years practice at least 3h of physical activity per week
men active old people	walking	men between 60 and 85 years practice at least 3h of physical activity per week
women with parkinson's disease	walking	women between 60 and 85 years presence of the disease according to the criteria of the UK Parkinson Disease Brain Bank
women with parkinson's disease	cognitive task	women between 60 and 85 years presence of the disease according to the criteria of the UK Parkinson Disease Brain Bank

Primary Outcome Measures

Name	Time	Method
concentration of cerebral oxyhemoglobin	day 1	The objective is to determine the effect of physical activity level on variations in cerebral oxygenation (combination of concentration of oxyhemoglobin and deoxyhemoglobin) during simple walking and during double task walking in elderly people.; Cerebral oxygenation will be determined continuously at rest and during walking. She will be measured non-invasively with a near infrared spectrometry system (Oxymon, Artinis Medical system, Netherlands). This system measures the evolution of the concentration of OxyHb and DeoxyHb by measuring the absorption of light into tissues.; The measurement of cerebral oxygenation will evaluate the hemodynamic response at the regional level during the cognitive task, the simple walking task and the dual task.
concentration of cerebral deoxyhemoglobin	day 1	The objective is to determine the effect of physical activity level on variations in cerebral oxygenation (combination of concentration of oxyhemoglobin and deoxyhemoglobin) during simple walking and during double task walking in elderly people.; Cerebral oxygenation will be determined continuously at rest and during walking. She will be measured non-invasively with a near infrared spectrometry system (Oxymon, Artinis Medical system, Netherlands). This system measures the evolution of the concentration of OxyHb and DeoxyHb by measuring the absorption of light into tissues.; The measurement of cerebral oxygenation will evaluate the hemodynamic response at the regional level during the cognitive task, the simple walking task and the dual task.

Secondary Outcome Measures

Name	Time	Method
cardiac frequency	day 1	Study the effect of age and gender on cardiac frequency during the simple walk and during the double task operation
Scale of perceived difficulties for perception of effort	day 1	This scale consists of 15 steps of ladder associated with verbal information (ranging from extremely easy for 2 to extremely difficult for 14) allowing the subjective descritpion of the difficulty of the task. With this scale the effect of gender on the perception of effort during the simple walk and during the double task will be studied.
concentration of muscular oxyhemoglobin	day 1	Study the effect of age and gender on muscular oxygenation during the simple walk and during the double task operation.; This will be measured non invasively with a near infrared spectrometry system (Oxymon, artinis medical system, netherlands)
measurement of cognitive performance using random number generation task	day 1	This task is for the particpants to state a number between 0 and 9 randomly at the fastest possible frequency by avoiding to state two consécutives digits one after the other (eg not to stay 5 then 6) . this task will be realised during simple walk and double task.
Step width: distance between the middle support point of each foot with optogait system	day 1	Study the effect of age on walking parameters during the simple walk and during the double task operation
concentration of muscular deoxyhemoglobin	day 1	Study the effect of age and gender on muscular oxygenation during the simple walk and during the double task operation.; This will be measured non invasively with a near infrared spectrometry system (Oxymon, artinis medical system, netherlands)

Trial Locations

Locations (1)

CHR Orléans; 🇫🇷 Orléans, France