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Clinical Trials/NCT04045444
NCT04045444
Completed
Not Applicable

Physical Activity Level and Cerebral Oxygenation During Gait in Old People

Centre Hospitalier Régional d'Orléans1 site in 1 country117 target enrollmentFebruary 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Oxygenation
Sponsor
Centre Hospitalier Régional d'Orléans
Enrollment
117
Locations
1
Primary Endpoint
concentration of cerebral oxyhemoglobin
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 25, 2019
End Date
April 20, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

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)

Outcomes

Primary Outcomes

concentration of cerebral oxyhemoglobin

Time Frame: 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

Time Frame: 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 Outcomes

  • Scale of perceived difficulties for perception of effort(day 1)
  • concentration of muscular oxyhemoglobin(day 1)
  • measurement of cognitive performance using random number generation task(day 1)
  • Step width: distance between the middle support point of each foot with optogait system(day 1)
  • concentration of muscular deoxyhemoglobin(day 1)
  • cardiac frequency(day 1)

Study Sites (1)

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