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Completed

NCT Number: NCT05866822

Adapted Physical Activity Education in Patients With Neurocognitive Disorder

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.

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Key information

Conditions

Neurocognitive Disorders Mental Disorders

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nice University Hospital

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mild neurocognitive disorder or early major neurocognitive disorder

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

Treatment and study plan

APA

Other

24 APA sessions

PAE

Other

8 individuals sessions of PAE

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. global cognition

    Time frame: at inclusion

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

  2. global cognition

    Time frame: at 3 months after inclusion

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

  3. global cognition

    Time frame: at 6 months after inclusion

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

  4. executive functions

    Time frame: at inclusion

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

  5. executive functions

    Time frame: at 3 months after inclusion

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

  6. executive functions

    Time frame: at 6 months after inclusion

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

  7. executive functions (FAB)

    Time frame: at inclusion

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

  8. executive functions (FAB)

    Time frame: at 3 months after inclusion

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

  9. executive functions (FAB)

    Time frame: at 6 months after inclusion

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

  10. executive functions (TMT)

    Time frame: at inclusion

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

  11. executive functions (TMT)

    Time frame: at 3 months after inclusion

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

  12. executive functions (TMT)

    Time frame: at 6 months after inclusion

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

  13. cardiovascular performance

    Time frame: at inclusion

    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

  14. cardiovascular performance

    Time frame: at 3 months after inclusion

    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

  15. cardiovascular performance

    Time frame: at 6 months after inclusion

    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

  16. power - physical condition

    Time frame: at inclusion

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

  17. power - physical condition

    Time frame: at 3 months after inclusion

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

  18. power - physical condition

    Time frame: at 6 months after inclusion

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

  19. strenght - physical condition

    Time frame: at inclusion

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

  20. strenght - physical condition

    Time frame: at 3 months after inclusion

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

  21. strenght - physical condition

    Time frame: at 6 months after inclusion

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

  22. evaluation of quality of life

    Time frame: at inclusion

    quality of life will be assessed by SF 12 a short version of the MEDICAL OUTCOME STUDY SHORT FORME GENERAL HEALTH SURVEY (score)

  23. evaluation of quality of life

    Time frame: at 3 months after inclusion

    quality of life will be assessed by SF 12 a short version of the MEDICAL OUTCOME STUDY SHORT FORME GENERAL HEALTH SURVEY (score)

  24. evaluation of quality of life

    Time frame: at 6 months after inclusion

    quality of life will be assessed by SF 12 a short version of the MEDICAL OUTCOME STUDY SHORT FORME GENERAL HEALTH SURVEY (score)

  25. anxiety and depression

    Time frame: at inclusion

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

  26. anxiety and depression

    Time frame: at 3 months after inclusion

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

  27. anxiety and depression

    Time frame: at 6 months after inclusion

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

  28. apathy

    Time frame: at inclusion

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

  29. apathy

    Time frame: at 3 months after inclusion

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

  30. apathy

    Time frame: at 6 months after inclusion

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Adapted Physical Activity Education in Patients With Neurocognitive Disorder: Single-blind, Single-center Randomized Controlled Trial

Acronym: EduAPA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 19, 2023
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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