Adapted Physical Activity Education in Patients With Neurocognitive Disorder

Neurocognitive Disorders Clinical Trial

— EduAPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05866822
• Other study ID #: 21-AOI-10
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: November 20, 2025

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Justine Lemaire
• Phone: 33492034778
• Email: lemaire.j[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: November 20, 2025
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurocognitive Disorders

Intervention

Other:
• APA
24 APA sessions
• PAE
8 individuals sessions of PAE

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical activity level	evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score	at inclusion
Primary	physical activity level	evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score	at 3 months after inclusion
Primary	physical activity level	evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score	at 6 months after inclusion
Secondary	global cognition	global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score	at inclusion
Secondary	global cognition	global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score	at 3 months after inclusion
Secondary	global cognition	global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score	at 6 months after inclusion
Secondary	executive functions	executiv functions will be assessed by FAB (frontal assessment battery)	at inclusion
Secondary	executive functions	executiv functions will be assessed by FAB (frontal assessment battery)	at 3 months after inclusion
Secondary	executive functions	executiv functions will be assessed by FAB (frontal assessment battery)	at 6 months after inclusion
Secondary	executive functions (FAB)	executiv functions will be assessed by FAB (frontal assessment battery) giving a score	at inclusion
Secondary	executive functions (FAB)	executiv functions will be assessed by FAB (frontal assessment battery) giving a score	at 3 months after inclusion
Secondary	executive functions (FAB)	executiv functions will be assessed by FAB (frontal assessment battery) giving a score	at 6 months after inclusion
Secondary	executive functions (TMT)	executiv functions will be assessed by TMT (frontal assessment battery) - giving a score	at inclusion
Secondary	executive functions (TMT)	executiv functions will be assessed by TMT (frontal assessment battery) - giving a score	at 3 months after inclusion
Secondary	executive functions (TMT)	executiv functions will be assessed by TMT (frontal assessment battery) - giving a score	at 6 months after inclusion
Secondary	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	at inclusion
Secondary	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	at 3 months after inclusion
Secondary	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	at 6 months after inclusion
Secondary	power - physical condition	physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score	at inclusion
Secondary	power - physical condition	physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score	at 3 months after inclusion
Secondary	power - physical condition	physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score	at 6 months after inclusion
Secondary	strenght - physical condition	physical condition will be asessed by grip strength (hand grip) with a score	at inclusion
Secondary	strenght - physical condition	physical condition will be asessed by grip strength (hand grip) with a score	at 3 months after inclusion
Secondary	strenght - physical condition	physical condition will be asessed by grip strength (hand grip) with a score	at 6 months after inclusion
Secondary	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)	at inclusion
Secondary	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)	at 3 months after inclusion
Secondary	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)	at 6 months after inclusion
Secondary	anxiety and depression	anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score	at inclusion
Secondary	anxiety and depression	anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score	at 3 months after inclusion
Secondary	anxiety and depression	anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score	at 6 months after inclusion
Secondary	apathy	apathy will be assessed by the apathy inventory questionnary and givig a score	at inclusion
Secondary	apathy	apathy will be assessed by the apathy inventory questionnary and givig a score	at 3 months after inclusion
Secondary	apathy	apathy will be assessed by the apathy inventory questionnary and givig a score	at 6 months after inclusion