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Clinical Trials/NCT05866822
NCT05866822
Recruiting
N/A

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

Centre Hospitalier Universitaire de Nice1 site in 1 country34 target enrollmentJanuary 5, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neurocognitive Disorders
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
34
Locations
1
Primary Endpoint
physical activity level
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2024
End Date
December 20, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • executive functions(at 6 months after inclusion)
  • executive functions (TMT)(at 6 months after inclusion)
  • cardiovascular performance(at 6 months after inclusion)
  • executive functions (FAB)(at 6 months after inclusion)
  • strenght - physical condition(at 6 months after inclusion)
  • global cognition(at 6 months after inclusion)
  • evaluation of quality of life(at 6 months after inclusion)
  • anxiety and depression(at 6 months after inclusion)
  • power - physical condition(at 6 months after inclusion)
  • apathy(at 6 months after inclusion)

Study Sites (1)

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