Adapted Physical Activity Education in Patients With Neurocognitive Disorder

NCT05866822 | Recruiting

• 1 other identifier: 21-AOI-10
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurocognitive Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (30)

• global cognition

  at inclusion

• global cognition

  at 3 months after inclusion

• global cognition

  at 6 months after inclusion

• executive functions

  at inclusion

• executive functions

  at 3 months after inclusion

Study Arms (2)

APA (adapted physical activity)

ACTIVE COMPARATOR

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

APA (adapted physical activity) + physical activity education (PAE)

EXPERIMENTAL

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; Other: PAE

Interventions

APA OTHER

24 APA sessions

APA (adapted physical activity); APA (adapted physical activity) + physical activity education (PAE)

PAE OTHER

8 individuals sessions of PAE

APA (adapted physical activity) + physical activity education (PAE)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• mild neurocognitive disorder or early major neurocognitive disorder

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Justine Lemaire

CONTACT

33492034778; lemaire.j@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 19, 2023
• Study Start: January 5, 2024
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): August 20, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (1)