OXYSENIOR: Cerebral Oxygenation During Gait in Elderly

Sponsor
Centre Hospitalier Régional d'Orléans (Other)
Overall Status
Completed
CT.gov ID
NCT04045444
Collaborator
(none)
117
1
8
25.8
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: walking
  • Other: cognitive task
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
117 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Physical Activity Level and Cerebral Oxygenation During Gait in Old People
Actual Study Start Date :
Feb 25, 2019
Actual Primary Completion Date :
Apr 20, 2021
Actual Study Completion Date :
Apr 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: women non active young people

women between 18 and 30 years practice less than 1h of physical activity per week

Other: walking
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be walking at 3 km/h, walking while doing the cognitive task, walking at the preferred speed, walking at the preferred speed while doing the cognitive task.

Other: cognitive task
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be a cognitive task, a control cognitive task.

Experimental: men non active young people

men between 18 and 30 years practice less than 1h of physical activity per week

Other: walking
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be walking at 3 km/h, walking while doing the cognitive task, walking at the preferred speed, walking at the preferred speed while doing the cognitive task.

Other: cognitive task
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be a cognitive task, a control cognitive task.

Experimental: women non active old people

women between 60 and 85 years practice less than 1h of physical activity per week

Other: walking
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be walking at 3 km/h, walking while doing the cognitive task, walking at the preferred speed, walking at the preferred speed while doing the cognitive task.

Other: cognitive task
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be a cognitive task, a control cognitive task.

Experimental: men non active old people

men between 60 and 85 years practice less than 1h of physical activity per week

Other: walking
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be walking at 3 km/h, walking while doing the cognitive task, walking at the preferred speed, walking at the preferred speed while doing the cognitive task.

Other: cognitive task
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be a cognitive task, a control cognitive task.

Experimental: women active old people

women between 60 and 85 years practice at least 3h of physical activity per week

Other: walking
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be walking at 3 km/h, walking while doing the cognitive task, walking at the preferred speed, walking at the preferred speed while doing the cognitive task.

Other: cognitive task
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be a cognitive task, a control cognitive task.

Experimental: men active old people

men between 60 and 85 years practice at least 3h of physical activity per week

Other: walking
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be walking at 3 km/h, walking while doing the cognitive task, walking at the preferred speed, walking at the preferred speed while doing the cognitive task.

Other: cognitive task
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be a cognitive task, a control cognitive task.

Experimental: women with parkinson's disease

women between 60 and 85 years presence of the disease according to the criteria of the UK Parkinson Disease Brain Bank

Other: walking
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be walking at 3 km/h, walking while doing the cognitive task, walking at the preferred speed, walking at the preferred speed while doing the cognitive task.

Other: cognitive task
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be a cognitive task, a control cognitive task.

Experimental: men with parkinson's disease

men between 60 and 85 years presence of the disease according to the criteria of the UK Parkinson Disease Brain Bank

Other: walking
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be walking at 3 km/h, walking while doing the cognitive task, walking at the preferred speed, walking at the preferred speed while doing the cognitive task.

Other: cognitive task
Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be a cognitive task, a control cognitive task.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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)

  2. 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)

  3. 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.

  4. cardiac frequency [day 1]

    Study the effect of age and gender on cardiac frequency during the simple walk and during the double task operation

  5. 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

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHR Orléans Orléans France 45067

Sponsors and Collaborators

  • Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Pascal AUZOU, MD, CHR orléans

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier:
NCT04045444
Other Study ID Numbers:
  • CHRO-2018-11
First Posted:
Aug 5, 2019
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Régional d'Orléans

Study Results

No Results Posted as of Sep 1, 2021