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CompletedNCT05866822EduAPAUpdated Jun 29, 2026

Adapted Physical Activity Education in Patients With Neurocognitive Disorder

An interventional study of APA and PAE in Neurocognitive Disorders, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Neurocognitive Disorders
03

In context

Neurocognitive Disorders

246 studies on the registry are indexed under Neurocognitive Disorders; 88 are open to participants now.

This study's enrollment of 30 is below the median of 72 across 150 interventional studies indexed under Neurocognitive Disorders.

Browse Neurocognitive Disorders studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • mild neurocognitive disorder or early major neurocognitive disorder

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    APA (adapted physical activity)

    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,

    Other: APA

  • Experimental
    APA (adapted physical activity) + physical activity education (PAE)

    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

    Other: APA · Other: PAE

Interventions

  • OtherAPA

    24 APA sessions

  • OtherPAE

    8 individuals sessions of PAE

06

What researchers measure

Primary outcomes

  1. physical activity level

    evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score

    Time frame: at inclusion

  2. physical activity level

    evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score

    Time frame: at 3 months after inclusion

  3. physical activity level

    evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score

    Time frame: at 6 months after inclusion

Secondary outcomes

  1. global cognition

    global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score

    Time frame: at inclusion

  2. global cognition

    global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score

    Time frame: at 3 months after inclusion

  3. global cognition

    global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score

    Time frame: at 6 months after inclusion

  4. executive functions

    executiv functions will be assessed by FAB (frontal assessment battery)

    Time frame: at inclusion

  5. executive functions

    executiv functions will be assessed by FAB (frontal assessment battery)

    Time frame: at 3 months after inclusion

  6. executive functions

    executiv functions will be assessed by FAB (frontal assessment battery)

    Time frame: at 6 months after inclusion

  7. executive functions (FAB)

    executiv functions will be assessed by FAB (frontal assessment battery) giving a score

    Time frame: at inclusion

  8. executive functions (FAB)

    executiv functions will be assessed by FAB (frontal assessment battery) giving a score

    Time frame: at 3 months after inclusion

  9. executive functions (FAB)

    executiv functions will be assessed by FAB (frontal assessment battery) giving a score

    Time frame: at 6 months after inclusion

  10. executive functions (TMT)

    executiv functions will be assessed by TMT (frontal assessment battery) - giving a score

    Time frame: at inclusion

  11. executive functions (TMT)

    executiv functions will be assessed by TMT (frontal assessment battery) - giving a score

    Time frame: at 3 months after inclusion

  12. executive functions (TMT)

    executiv functions will be assessed by TMT (frontal assessment battery) - giving a score

    Time frame: at 6 months after inclusion

  13. 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

    Time frame: at inclusion

  14. 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

    Time frame: at 3 months after inclusion

  15. 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

    Time frame: at 6 months after inclusion

  16. power - physical condition

    physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score

    Time frame: at inclusion

  17. power - physical condition

    physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score

    Time frame: at 3 months after inclusion

  18. power - physical condition

    physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score

    Time frame: at 6 months after inclusion

  19. strenght - physical condition

    physical condition will be asessed by grip strength (hand grip) with a score

    Time frame: at inclusion

  20. strenght - physical condition

    physical condition will be asessed by grip strength (hand grip) with a score

    Time frame: at 3 months after inclusion

  21. strenght - physical condition

    physical condition will be asessed by grip strength (hand grip) with a score

    Time frame: at 6 months after inclusion

  22. 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)

    Time frame: at inclusion

  23. 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)

    Time frame: at 3 months after inclusion

  24. 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)

    Time frame: at 6 months after inclusion

  25. anxiety and depression

    anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score

    Time frame: at inclusion

  26. anxiety and depression

    anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score

    Time frame: at 3 months after inclusion

  27. anxiety and depression

    anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score

    Time frame: at 6 months after inclusion

  28. apathy

    apathy will be assessed by the apathy inventory questionnary and givig a score

    Time frame: at inclusion

  29. apathy

    apathy will be assessed by the apathy inventory questionnary and givig a score

    Time frame: at 3 months after inclusion

  30. apathy

    apathy will be assessed by the apathy inventory questionnary and givig a score

    Time frame: at 6 months after inclusion

07

Study locations

1 site
  • Nice University Hospital
    Nice, 06000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05866822
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
May 19, 2023
Start date
Jan 5, 2024
Primary completion
Apr 27, 2026
Completion
Apr 27, 2026
Last update
Jun 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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