Neurocognitive DisordersEduAPANCT05866822
Adapted Physical Activity Education in Patients With Neurocognitive Disorder
A study testing APA and PAE in people with Neurocognitive Disorders, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
This study aims to compare the effect of a program of Adapted Physical Activity (APA) versus the same program combined with a physical activity education program (PAE). Patients suffering from neurocognitive disorders (mild or early major) will be randomized into one of the two conditions. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Neurocognitive Disorders
- What is being tested?
- APA and PAE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2024to 27 Apr 2026
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- mild neurocognitive disorder or early major neurocognitive disorder
Who cannot join
- Medical pathology involving the vital prognosis in the short term
- Major neurocognitive disorder at moderate stage and beyond (DSM 5) and/or MMSE < 20
- Unbalanced depressive syndrom
- Contraindication to the practice of the exercises proposed during the study;
- Major hearing or visual impairment;
- Sufficiently active with regard to the daily recommendations described by the WHO
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapted Physical Activity Education in Patients With Neurocognitive Disorder: Single-blind, Single-center Randomized Controlled Trial
This study aims to compare the effect of a program of Adapted Physical Activity (APA) versus the same program combined with a physical activity education program (PAE). Patients suffering from neurocognitive disorders (mild or early major) will be randomized into one of the two conditions. 3 complete evaluations will be done (inclusion M0, after 3 month of intervention M3, 3 months after the end of the intervention M6). The team except that APA+PEA will be more effectiv than the APA solely, on the following criteria : level of physical activity, cogntive function and quality of life.
- Conditions
- Neurocognitive Disorders
- Being tested
- APA, PAE
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APAOther
24 APA sessions
PAEOther
8 individuals sessions of PAE
| Study group | Role | What they receive |
|---|---|---|
| APA (adapted physical activity) | Active comparator | 24 APA sessions will take place, there will be 2 sessions a week for 12 weeks which will include global exercises for the upper and lower limb. One session will be 1 hour long and supervised by professionals. It will be divided in 4 cycles which will be differentiated by the intensity of its components: aerobic, strength, speed, balance, coordination and flexibility. The intensity of the sessions will be measured by RPE and heart rate monitor, Receives: Other: APA |
| APA (adapted physical activity) + physical activity education (PAE) | Experimental | 24 APA sessions will take place, there will be 2 sessions a week for 12 weeks which will include global exercises for the upper and lower limb. One session will be 1 hour long and supervised by professionals. It will be divided in 4 cycles which will be differentiated by the intensity of its components: aerobic, strength, speed, balance, coordination and flexibility. The intensity of the sessions will be measured by RPE and heart rate monitor,
+ 8 individuals sessions of PAE (one per week, half an hour long) that will consist of advising and setting weekly goals related to improving PA level and sedentary behavior Receives: Other: APA; Other: PAE |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity level
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
Measured: at inclusion
physical activity level
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
Measured: at 3 months after inclusion
physical activity level
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
Measured: at 6 months after inclusion
Secondary outcomes (30)
global cognition
global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
Measured: at inclusion
global cognition
global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
Measured: at 3 months after inclusion
global cognition
global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
Measured: at 6 months after inclusion
executive functions
executiv functions will be assessed by FAB (frontal assessment battery)
Measured: at inclusion
executive functions
executiv functions will be assessed by FAB (frontal assessment battery)
Measured: at 3 months after inclusion
executive functions
executiv functions will be assessed by FAB (frontal assessment battery)
Measured: at 6 months after inclusion
executive functions (FAB)
executiv functions will be assessed by FAB (frontal assessment battery) giving a score
Measured: at inclusion
executive functions (FAB)
executiv functions will be assessed by FAB (frontal assessment battery) giving a score
Measured: at 3 months after inclusion
executive functions (FAB)
executiv functions will be assessed by FAB (frontal assessment battery) giving a score
Measured: at 6 months after inclusion
executive functions (TMT)
executiv functions will be assessed by TMT (frontal assessment battery) - giving a score
Measured: at inclusion
executive functions (TMT)
executiv functions will be assessed by TMT (frontal assessment battery) - giving a score
Measured: at 3 months after inclusion
executive functions (TMT)
executiv functions will be assessed by TMT (frontal assessment battery) - giving a score
Measured: at 6 months after inclusion
cardiovascular performance
Cardiovascular performance will be evaluated through a effort test that will be performed on a stationary bicycle ergometer connected to a portable gas exchange analysis system in ml/kg/min
Measured: at inclusion
cardiovascular performance
Cardiovascular performance will be evaluated through a effort test that will be performed on a stationary bicycle ergometer connected to a portable gas exchange analysis system in ml/kg/min
Measured: at 3 months after inclusion
cardiovascular performance
Cardiovascular performance will be evaluated through a effort test that will be performed on a stationary bicycle ergometer connected to a portable gas exchange analysis system in ml/kg/min
Measured: at 6 months after inclusion
power - physical condition
physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
Measured: at inclusion
power - physical condition
physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
Measured: at 3 months after inclusion
power - physical condition
physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
Measured: at 6 months after inclusion
strenght - physical condition
physical condition will be asessed by grip strength (hand grip) with a score
Measured: at inclusion
strenght - physical condition
physical condition will be asessed by grip strength (hand grip) with a score
Measured: at 3 months after inclusion
strenght - physical condition
physical condition will be asessed by grip strength (hand grip) with a score
Measured: at 6 months after inclusion
evaluation of quality of life
quality of life will be assessed by SF 12 a short version of the MEDICAL OUTCOME STUDY SHORT FORME GENERAL HEALTH SURVEY (score)
Measured: at inclusion
evaluation of quality of life
quality of life will be assessed by SF 12 a short version of the MEDICAL OUTCOME STUDY SHORT FORME GENERAL HEALTH SURVEY (score)
Measured: at 3 months after inclusion
evaluation of quality of life
quality of life will be assessed by SF 12 a short version of the MEDICAL OUTCOME STUDY SHORT FORME GENERAL HEALTH SURVEY (score)
Measured: at 6 months after inclusion
anxiety and depression
anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score
Measured: at inclusion
anxiety and depression
anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score
Measured: at 3 months after inclusion
anxiety and depression
anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score
Measured: at 6 months after inclusion
apathy
apathy will be assessed by the apathy inventory questionnary and givig a score
Measured: at inclusion
apathy
apathy will be assessed by the apathy inventory questionnary and givig a score
Measured: at 3 months after inclusion
apathy
apathy will be assessed by the apathy inventory questionnary and givig a score
Measured: at 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start5 Jan 2024
- Primary completion27 Apr 2026
- Study completion27 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866822
- Sponsor's protocol ID
- 21-AOI-10
- Acronym
- EduAPA
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Physical Activity Education in Patients With Neurocognitive Disorder: Single-blind, Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05866822
- Acronym / sponsor ID
- EduAPA / 21-AOI-10
- Conditions
- Neurocognitive Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 27 Apr 2026 (actual)
- Study completion
- 27 Apr 2026 (actual)
- First posted
- 19 May 2023 (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.
This study aims to compare the effect of a program of Adapted Physical Activity (APA) versus the same program combined with a physical activity education program (PAE). Patients suffering from neurocognitive disorders (mild or early major) will be randomized into one of the two conditions. 3 complete evaluations will be done (inclusion M0, after 3 month of intervention M3, 3 months after the end of the intervention M6). The team except that APA+PEA will be more effectiv than the APA solely, on the following criteria : level of physical activity, cogntive function and quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APA (adapted physical activity) | Active comparator | Other: APA24 APA sessions will take place, there will be 2 sessions a week for 12 weeks which will include global exercises for the upper and lower limb. One session will be 1 hour long and supervised by professionals. It will be divided in 4 cycles which will be differentiated by the intensity of its components: aerobic, strength, speed, balance, coordination and flexibility. The intensity of the sessions will be measured by RPE and heart rate monitor, |
| APA (adapted physical activity) + physical activity education (PAE) | Experimental | Other: APA, Other: PAE24 APA sessions will take place, there will be 2 sessions a week for 12 weeks which will include global exercises for the upper and lower limb. One session will be 1 hour long and supervised by professionals. It will be divided in 4 cycles which will be differentiated by the intensity of its components: aerobic, strength, speed, balance, coordination and flexibility. The intensity of the sessions will be measured by RPE and heart rate monitor, + 8 individuals sessions of PAE (one per week, half an hour long) that will consist of advising and setting weekly goals related to improving PA level and sedentary behavior |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- mild neurocognitive disorder or early major neurocognitive disorder
Key exclusion criteria (6 listed)
- Medical pathology involving the vital prognosis in the short term
- Major neurocognitive disorder at moderate stage and beyond (DSM 5) and/or MMSE < 20
- Unbalanced depressive syndrom
- Contraindication to the practice of the exercises proposed during the study;
- Major hearing or visual impairment;
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 |
|---|---|---|
| APA24 APA sessions | Other | APA (adapted physical activity), APA (adapted physical activity) + physical activity education (PAE) |
| PAE8 individuals sessions of PAE | Other | APA (adapted physical activity) + physical activity education (PAE) |
Primary outcome
physical activity level
Time frame: at inclusion
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
physical activity level
Time frame: at 3 months after inclusion
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
physical activity level
Time frame: at 6 months after inclusion
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
30 secondary outcomes
global cognition
Time frame: at inclusion
global cognition
Time frame: at 3 months after inclusion
global cognition
Time frame: at 6 months after inclusion
executive functions
Time frame: at inclusion
executive functions
Time frame: at 3 months after inclusion
executive functions
Time frame: at 6 months after inclusion
executive functions (FAB)
Time frame: at inclusion
executive functions (FAB)
Time frame: at 3 months after inclusion
executive functions (FAB)
Time frame: at 6 months after inclusion
executive functions (TMT)
Time frame: at inclusion
executive functions (TMT)
Time frame: at 3 months after inclusion
executive functions (TMT)
Time frame: at 6 months after inclusion
cardiovascular performance
Time frame: at inclusion
cardiovascular performance
Time frame: at 3 months after inclusion
cardiovascular performance
Time frame: at 6 months after inclusion
power - physical condition
Time frame: at inclusion
power - physical condition
Time frame: at 3 months after inclusion
power - physical condition
Time frame: at 6 months after inclusion
strenght - physical condition
Time frame: at inclusion
strenght - physical condition
Time frame: at 3 months after inclusion
strenght - physical condition
Time frame: at 6 months after inclusion
evaluation of quality of life
Time frame: at inclusion
evaluation of quality of life
Time frame: at 3 months after inclusion
evaluation of quality of life
Time frame: at 6 months after inclusion
anxiety and depression
Time frame: at inclusion
anxiety and depression
Time frame: at 3 months after inclusion
anxiety and depression
Time frame: at 6 months after inclusion
apathy
Time frame: at inclusion
apathy
Time frame: at 3 months after inclusion
apathy
Time frame: at 6 months after inclusion
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 29 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APA and PAE in people with Neurocognitive Disorders, run by Centre Hospitalier Universitaire de Nice 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 1 inclusion and 6 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 29 Jun 2026. 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?
physical activity level (time frame: at inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.