Adapted Physical Activity Education in Patients With Neurocognitive Disorder

NCT ID: NCT05866822

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-05

Study Completion Date

2025-12-20

Brief Summary

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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

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Conditions

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Neurocognitive Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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,

Group Type ACTIVE_COMPARATOR

APA

Intervention Type OTHER

24 APA sessions

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

Group Type EXPERIMENTAL

APA

Intervention Type OTHER

24 APA sessions

PAE

Intervention Type OTHER

8 individuals sessions of PAE

Interventions

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APA

24 APA sessions

Intervention Type OTHER

PAE

8 individuals sessions of PAE

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nice University Hospital

Nice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Justine Lemaire

Role: CONTACT

33492034778

Facility Contacts

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Justine Lemaire

Role: primary

33492034778

Guillaume Sacco, PH

Role: backup

33492034778

Other Identifiers

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21-AOI-10

Identifier Type: -

Identifier Source: org_study_id

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