Cerebral OxygenationOXYSENIORNCT04045444
Cerebral Oxygenation During Gait in Elderly
A study testing walking and cognitive task in people with Cerebral Oxygenation, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Oxygenation
- What is being tested?
- walking and cognitive task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2019to 20 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 22Show fewer
- 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
Who cannot join
- -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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity Level and Cerebral Oxygenation During Gait in Old People
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.
Read the 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.
- Conditions
- Cerebral Oxygenation
- Being tested
- walking, cognitive task
- Keywords
- physical activity, cognitive function, elderly, parkinson, muscle oxygenation, gait parameters
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| women non active young people | Experimental | women between 18 and 30 years practice less than 1h of physical activity per week Receives: Other: walking; Other: cognitive task |
| men non active young people | Experimental | men between 18 and 30 years practice less than 1h of physical activity per week Receives: Other: walking; Other: cognitive task |
| women non active old people | Experimental | women between 60 and 85 years practice less than 1h of physical activity per week Receives: Other: walking; Other: cognitive task |
| men non active old people | Experimental | men between 60 and 85 years practice less than 1h of physical activity per week Receives: Other: walking; Other: cognitive task |
| women active old people | Experimental | women between 60 and 85 years practice at least 3h of physical activity per week Receives: Other: walking; Other: cognitive task |
| men active old people | Experimental | men between 60 and 85 years practice at least 3h of physical activity per week Receives: Other: walking; Other: 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 Receives: Other: walking; Other: 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 Receives: Other: walking; Other: cognitive task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: day 1
Secondary outcomes (6)
concentration of muscular oxyhemoglobin
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)
Measured: day 1
concentration of muscular deoxyhemoglobin
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)
Measured: day 1
measurement of cognitive performance using random number generation task
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.
Measured: day 1
cardiac frequency
Study the effect of age and gender on cardiac frequency during the simple walk and during the double task operation
Measured: day 1
Step width: distance between the middle support point of each foot with optogait system
Study the effect of age on walking parameters during the simple walk and during the double task operation
Measured: day 1
Scale of perceived difficulties for perception of effort
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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start25 Feb 2019
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal AUZOU, MD, Principal investigator, CHR orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045444
- Sponsor's protocol ID
- CHRO-2018-11
- Acronym
- OXYSENIOR
- Status last verified
- Aug 2021
- First submitted
- 21 Feb 2019
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderton BH. Ageing of the brain. Mech Ageing Dev. 2002 Apr;123(7):811-7. doi: 10.1016/s0047-6374(01)00426-2.
PubMed 11869738Andres 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.
PubMed 11078107Asllani 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.
PubMed 19172645Azulay 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.
PubMed 8761620
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Level and Cerebral Oxygenation During Gait in Old People
- ClinicalTrials.gov ID
- NCT04045444
- Acronym / sponsor ID
- OXYSENIOR / CHRO-2018-11
- Conditions
- Cerebral Oxygenation
- Keywords
- physical activity, cognitive function, elderly, parkinson, muscle oxygenation, gait parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| women non active young people | Experimental | Other: walking, Other: cognitive taskwomen between 18 and 30 years practice less than 1h of physical activity per week |
| men non active young people | Experimental | Other: walking, Other: cognitive taskmen between 18 and 30 years practice less than 1h of physical activity per week |
| women non active old people | Experimental | Other: walking, Other: cognitive taskwomen between 60 and 85 years practice less than 1h of physical activity per week |
| men non active old people | Experimental | Other: walking, Other: cognitive taskmen between 60 and 85 years practice less than 1h of physical activity per week |
| women active old people | Experimental | Other: walking, Other: cognitive taskwomen between 60 and 85 years practice at least 3h of physical activity per week |
| men active old people | Experimental | Other: walking, Other: cognitive taskmen between 60 and 85 years practice at least 3h of physical activity per week |
| women with parkinson's disease | Experimental | Other: walking, Other: cognitive taskwomen between 60 and 85 years presence of the disease according to the criteria of the UK Parkinson Disease Brain Bank |
| men with parkinson's disease | Experimental | Other: walking, Other: cognitive taskmen between 60 and 85 years presence of the disease according to the criteria of the UK Parkinson Disease Brain Bank |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- 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
- 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
Key exclusion criteria (1 listed)
- -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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walkingEvery 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 | men active old people, men non active old people, men non active young people, men with parkinson's disease, women active old people, women non active old people, women non active young people, women with parkinson's disease |
| cognitive taskEvery 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. | Other | men active old people, men non active old people, men non active young people, men with parkinson's disease, women active old people, women non active old people, women non active young people, women with parkinson's disease |
Primary outcome
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.
6 secondary outcomes
concentration of muscular oxyhemoglobin
Time frame: day 1
concentration of muscular deoxyhemoglobin
Time frame: day 1
measurement of cognitive performance using random number generation task
Time frame: day 1
cardiac frequency
Time frame: day 1
Step width: distance between the middle support point of each foot with optogait system
Time frame: day 1
Scale of perceived difficulties for perception of effort
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Background: PubMed 11869738Anderton BH. Ageing of the brain. Mech Ageing Dev. 2002 Apr;123(7):811-7. doi: 10.1016/s0047-6374(01)00426-2.
- Background: PubMed 11078107Andres 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.
- Background: PubMed 19172645Asllani 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.
- Background: PubMed 8761620Azulay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal AUZOU, MD principal investigator
CHR orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking and cognitive task in people with Cerebral Oxygenation, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of cerebral oxyhemoglobin (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04045444, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.