NCT04045444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

2.2 years

First QC Date

February 21, 2019

Last Update Submit

August 31, 2021

Conditions

Cerebral Oxygenation

Keywords

physical activitycognitive functionelderlyparkinsonmuscle oxygenationgait parameters

Outcome Measures

Primary Outcomes (2)

  • concentration of cerebral oxyhemoglobin

    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.

    day 1

  • concentration of cerebral deoxyhemoglobin

    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.

    day 1

Secondary Outcomes (6)

  • concentration of muscular oxyhemoglobin

    day 1

  • concentration of muscular deoxyhemoglobin

    day 1

  • measurement of cognitive performance using random number generation task

    day 1

  • cardiac frequency

    day 1

  • Step width: distance between the middle support point of each foot with optogait system

    day 1

  • +1 more secondary outcomes

Study Arms (8)

women non active young people

EXPERIMENTAL

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

Other: walkingOther: cognitive task

men non active young people

EXPERIMENTAL

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

Other: walkingOther: cognitive task

women non active old people

EXPERIMENTAL

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

Other: walkingOther: cognitive task

men non active old people

EXPERIMENTAL

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

Other: walkingOther: cognitive task

women active old people

EXPERIMENTAL

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

Other: walkingOther: cognitive task

men active old people

EXPERIMENTAL

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

Other: walkingOther: cognitive task

women with parkinson's disease

EXPERIMENTAL

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

Other: walkingOther: cognitive task

men with parkinson's disease

EXPERIMENTAL

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

Other: walkingOther: cognitive task

Interventions

walkingOTHER

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.

men active old peoplemen non active old peoplemen non active young peoplemen with parkinson's diseasewomen active old peoplewomen non active old peoplewomen non active young peoplewomen with parkinson's disease
cognitive taskOTHER

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.

men active old peoplemen non active old peoplemen non active young peoplemen with parkinson's diseasewomen active old peoplewomen non active old peoplewomen non active young peoplewomen with parkinson's disease

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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
  • +6 more criteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Orléans

Orléans, 45067, France

Location

Related Publications (4)

  • Anderton BH. Ageing of the brain. Mech Ageing Dev. 2002 Apr;123(7):811-7. doi: 10.1016/s0047-6374(01)00426-2.

    PMID: 11869738BACKGROUND

  • 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.

    PMID: 11078107BACKGROUND

  • 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.

    PMID: 19172645BACKGROUND

  • 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.

    PMID: 8761620BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Pascal AUZOU, MD

    CHR orléans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

August 5, 2019

Study Start

February 25, 2019

Primary Completion

April 20, 2021

Study Completion

April 20, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)