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

June 26, 2026 updated by: Centre Hospitalier Universitaire de Nice

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nice, France, 06000
        • Nice University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
physical activity level
Time Frame: at inclusion
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
at inclusion
physical activity level
Time Frame: at 3 months after inclusion
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
Time Frame: at 6 months after inclusion
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
global cognition
Time Frame: at inclusion
global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
at inclusion
global cognition
Time Frame: at 3 months after inclusion
global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
at 3 months after inclusion
global cognition
Time Frame: at 6 months after inclusion
global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
at 6 months after inclusion
executive functions
Time Frame: at inclusion
executiv functions will be assessed by FAB (frontal assessment battery)
at inclusion
executive functions
Time Frame: at 3 months after inclusion
executiv functions will be assessed by FAB (frontal assessment battery)
at 3 months after inclusion
executive functions
Time Frame: at 6 months after inclusion
executiv functions will be assessed by FAB (frontal assessment battery)
at 6 months after inclusion
executive functions (FAB)
Time Frame: at inclusion
executiv functions will be assessed by FAB (frontal assessment battery) giving a score
at inclusion
executive functions (FAB)
Time Frame: at 3 months after inclusion
executiv functions will be assessed by FAB (frontal assessment battery) giving a score
at 3 months after inclusion
executive functions (FAB)
Time Frame: at 6 months after inclusion
executiv functions will be assessed by FAB (frontal assessment battery) giving a score
at 6 months after inclusion
executive functions (TMT)
Time Frame: at inclusion
executiv functions will be assessed by TMT (frontal assessment battery) - giving a score
at inclusion
executive functions (TMT)
Time Frame: at 3 months after inclusion
executiv functions will be assessed by TMT (frontal assessment battery) - giving a score
at 3 months after inclusion
executive functions (TMT)
Time Frame: at 6 months after inclusion
executiv functions will be assessed by TMT (frontal assessment battery) - giving a score
at 6 months after inclusion
cardiovascular performance
Time Frame: at 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
at inclusion
cardiovascular performance
Time Frame: at 3 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
at 3 months after inclusion
cardiovascular performance
Time Frame: 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
at 6 months after inclusion
power - physical condition
Time Frame: at inclusion
physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
at inclusion
power - physical condition
Time Frame: at 3 months after inclusion
physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
at 3 months after inclusion
power - physical condition
Time Frame: at 6 months after inclusion
physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
at 6 months after inclusion
strenght - physical condition
Time Frame: at inclusion
physical condition will be asessed by grip strength (hand grip) with a score
at inclusion
strenght - physical condition
Time Frame: at 3 months after inclusion
physical condition will be asessed by grip strength (hand grip) with a score
at 3 months after inclusion
strenght - physical condition
Time Frame: at 6 months after inclusion
physical condition will be asessed by grip strength (hand grip) with a score
at 6 months after inclusion
evaluation of quality of life
Time Frame: at inclusion
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
Time Frame: at 3 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)
at 3 months after inclusion
evaluation of quality of life
Time Frame: 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)
at 6 months after inclusion
anxiety and depression
Time Frame: at inclusion
anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score
at inclusion
anxiety and depression
Time Frame: at 3 months after inclusion
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
Time Frame: at 6 months after inclusion
anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score
at 6 months after inclusion
apathy
Time Frame: at inclusion
apathy will be assessed by the apathy inventory questionnary and givig a score
at inclusion
apathy
Time Frame: at 3 months after inclusion
apathy will be assessed by the apathy inventory questionnary and givig a score
at 3 months after inclusion
apathy
Time Frame: at 6 months after inclusion
apathy will be assessed by the apathy inventory questionnary and givig a score
at 6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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