Adapted Physical Activity Education in Patients With Neurocognitive Disorder

Not Applicable

Recruiting

• Conditions: Neurocognitive Disorders

• Registration Number: NCT05866822
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-05-10
• Study First Posted: 2023-05-19
• Study Start: 2024-01-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-11-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
physical activity level	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 Outcome Measures

Name	Time	Method
executive functions	at 6 months after inclusion	executiv functions will be assessed by FAB (frontal assessment battery)
executive functions (TMT)	at 6 months after inclusion	executiv functions will be assessed by TMT (frontal assessment battery) - giving a score
cardiovascular performance	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
executive functions (FAB)	at 6 months after inclusion	executiv functions will be assessed by FAB (frontal assessment battery) giving a score
strenght - physical condition	at 6 months after inclusion	physical condition will be asessed by grip strength (hand grip) with a score
global cognition	at 6 months after inclusion	global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
evaluation of quality of life	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)
anxiety and depression	at 6 months after inclusion	anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score
power - physical condition	at 6 months after inclusion	physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
apathy	at 6 months after inclusion	apathy will be assessed by the apathy inventory questionnary and givig a score

Trial Locations

Locations (1)

Nice University Hospital; 🇫🇷 Nice, France