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Adapted Physical Activity Education in Patients With Neurocognitive Disorder

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05866822
Acronym
EduAPA
Enrollment
34
Registered
2023-05-19
Start date
2024-01-05
Completion date
2027-08-20
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurocognitive Disorders

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.

Interventions

OTHERAPA

24 APA sessions

OTHERPAE

8 individuals sessions of PAE

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
physical activity levelat inclusionevolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score

Secondary

MeasureTime frameDescription
global cognitionat inclusionglobal cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
executive functionsat inclusionexecutiv functions will be assessed by FAB (frontal assessment battery)
executive functions (FAB)at inclusionexecutiv functions will be assessed by FAB (frontal assessment battery) giving a score
executive functions (TMT)at inclusionexecutiv functions will be assessed by TMT (frontal assessment battery) - giving a score
cardiovascular performanceat inclusionCardiovascular 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
power - physical conditionat inclusionphysical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
strenght - physical conditionat inclusionphysical condition will be asessed by grip strength (hand grip) with a score
evaluation of quality of lifeat inclusionquality of life will be assessed by SF 12 a short version of the MEDICAL OUTCOME STUDY SHORT FORME GENERAL HEALTH SURVEY (score)
anxiety and depressionat inclusionanxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score
apathyat inclusionapathy will be assessed by the apathy inventory questionnary and givig a score

Countries

France

Contacts

CONTACTJustine Lemaire
lemaire.j@chu-nice.fr33492034778

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026