Adapted Physical Activity Education in Patients With Neurocognitive Disorder (EduAPA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurocognitive Disorders
• Intervention / Treatment: Other: APA; Other: PAE

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justine Lemaire; Phone Number: 33492034778; Email: lemaire.j@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Nice University Hospital
    • Contact: Justine Lemaire; Phone Number: 33492034778; Email: lemaire.j@chu-nice.fr
    • Contact: Guillaume Sacco, PH; Phone Number: 33492034778; Email: sacco.g@chu-nice.fr
    • Principal Investigator: Guillaume SACCO, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: APA (adapted physical activity); 24 APA sessions will take place, there will be 2 sessions a week for 12 weeks which will include global exercises for the upper and lower limb. One session will be 1 hour long and supervised by professionals. It will be divided in 4 cycles which will be differentiated by the intensity of its components: aerobic, strength, speed, balance, coordination and flexibility. The intensity of the sessions will be measured by RPE and heart rate monitor,	Other: APA; 24 APA sessions
Experimental: APA (adapted physical activity) + physical activity education (PAE); 24 APA sessions will take place, there will be 2 sessions a week for 12 weeks which will include global exercises for the upper and lower limb. One session will be 1 hour long and supervised by professionals. It will be divided in 4 cycles which will be differentiated by the intensity of its components: aerobic, strength, speed, balance, coordination and flexibility. The intensity of the sessions will be measured by RPE and heart rate monitor, + 8 individuals sessions of PAE (one per week, half an hour long) that will consist of advising and setting weekly goals related to improving PA level and sedentary behavior	Other: APA; 24 APA sessions; Other: PAE; 8 individuals sessions of PAE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physical activity level	evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score	at inclusion
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
global cognition	global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score	at inclusion
global cognition	global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score	at 3 months after inclusion
global cognition	global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score	at 6 months after inclusion
executive functions	executiv functions will be assessed by FAB (frontal assessment battery)	at inclusion
executive functions	executiv functions will be assessed by FAB (frontal assessment battery)	at 3 months after inclusion
executive functions	executiv functions will be assessed by FAB (frontal assessment battery)	at 6 months after inclusion
executive functions (FAB)	executiv functions will be assessed by FAB (frontal assessment battery) giving a score	at inclusion
executive functions (FAB)	executiv functions will be assessed by FAB (frontal assessment battery) giving a score	at 3 months after inclusion
executive functions (FAB)	executiv functions will be assessed by FAB (frontal assessment battery) giving a score	at 6 months after inclusion
executive functions (TMT)	executiv functions will be assessed by TMT (frontal assessment battery) - giving a score	at inclusion
executive functions (TMT)	executiv functions will be assessed by TMT (frontal assessment battery) - giving a score	at 3 months after inclusion
executive functions (TMT)	executiv functions will be assessed by TMT (frontal assessment battery) - giving a score	at 6 months after inclusion
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
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
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
power - physical condition	physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score	at inclusion
power - physical condition	physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score	at 3 months after inclusion
power - physical condition	physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score	at 6 months after inclusion
strenght - physical condition	physical condition will be asessed by grip strength (hand grip) with a score	at inclusion
strenght - physical condition	physical condition will be asessed by grip strength (hand grip) with a score	at 3 months after inclusion
strenght - physical condition	physical condition will be asessed by grip strength (hand grip) with a score	at 6 months after inclusion
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
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
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
anxiety and depression	anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score	at inclusion
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
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
apathy	apathy will be assessed by the apathy inventory questionnary and givig a score	at inclusion
apathy	apathy will be assessed by the apathy inventory questionnary and givig a score	at 3 months after inclusion
apathy	apathy will be assessed by the apathy inventory questionnary and givig a score	at 6 months after inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): August 20, 2027

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders
• Other Study ID Numbers: 21-AOI-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No