Clinical trial NCT05866822: Adapted Physical Activity Education in Patients With Neurocognitive Disorder
Official title: Adapted Physical Activity Education in Patients With Neurocognitive Disorder: Single-blind, Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurocognitive Disorders
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 34
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: physical activity level
timeFrame: at inclusion
measure: physical activity level
timeFrame: at 3 months after inclusion
measure: physical activity level
timeFrame: at 6 months after inclusion
Secondary outcomes:
measure: global cognition
timeFrame: at inclusion
measure: global cognition
timeFrame: at 3 months after inclusion
measure: global cognition
timeFrame: at 6 months after inclusion
measure: executive functions
timeFrame: at inclusion
measure: executive functions
timeFrame: at 3 months after inclusion
measure: executive functions
timeFrame: at 6 months after inclusion
measure: executive functions (FAB)
timeFrame: at inclusion
measure: executive functions (FAB)
timeFrame: at 3 months after inclusion
measure: executive functions (FAB)
timeFrame: at 6 months after inclusion
measure: executive functions (TMT)
timeFrame: at inclusion
measure: executive functions (TMT)
timeFrame: at 3 months after inclusion
measure: executive functions (TMT)
timeFrame: at 6 months after inclusion
measure: cardiovascular performance
timeFrame: at inclusion
measure: cardiovascular performance
timeFrame: at 3 months after inclusion
measure: cardiovascular performance
timeFrame: at 6 months after inclusion
measure: power - physical condition
timeFrame: at inclusion
measure: power - physical condition
timeFrame: at 3 months after inclusion
measure: power - physical condition
timeFrame: at 6 months after inclusion
measure: strenght - physical condition
timeFrame: at inclusion
measure: strenght - physical condition
timeFrame: at 3 months after inclusion
measure: strenght - physical condition
timeFrame: at 6 months after inclusion
measure: evaluation of quality of life
timeFrame: at inclusion
measure: evaluation of quality of life
timeFrame: at 3 months after inclusion
measure: evaluation of quality of life
timeFrame: at 6 months after inclusion
measure: anxiety and depression
timeFrame: at inclusion
measure: anxiety and depression
timeFrame: at 3 months after inclusion
measure: anxiety and depression
timeFrame: at 6 months after inclusion
measure: apathy
timeFrame: at inclusion
measure: apathy
timeFrame: at 3 months after inclusion
measure: apathy
timeFrame: at 6 months after inclusion
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References: