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

Primary Purpose

Neurocognitive Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
APA
PAE
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neurocognitive Disorders

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nice University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

APA (adapted physical activity)

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

Arm Description

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,

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

Outcomes

Primary Outcome Measures

physical activity level
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
physical activity level
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
physical activity level
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score

Secondary Outcome Measures

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

Full Information

First Posted
April 28, 2023
Last Updated
May 10, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05866822
Brief Title
Adapted Physical Activity Education in Patients With Neurocognitive Disorder
Acronym
EduAPA
Official Title
Adapted Physical Activity Education in Patients With Neurocognitive Disorder: Single-blind, Single-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 20, 2023 (Anticipated)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
November 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocognitive Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
APA (adapted physical activity)
Arm Type
Active Comparator
Arm Description
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,
Arm Title
APA (adapted physical activity) + physical activity education (PAE)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
APA
Intervention Description
24 APA sessions
Intervention Type
Other
Intervention Name(s)
PAE
Intervention Description
8 individuals sessions of PAE
Primary Outcome Measure Information:
Title
physical activity level
Description
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
Time Frame
at inclusion
Title
physical activity level
Description
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
Time Frame
at 3 months after inclusion
Title
physical activity level
Description
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
Time Frame
at 6 months after inclusion
Secondary Outcome Measure Information:
Title
global cognition
Description
global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
Time Frame
at inclusion
Title
global cognition
Description
global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
Time Frame
at 3 months after inclusion
Title
global cognition
Description
global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score
Time Frame
at 6 months after inclusion
Title
executive functions
Description
executiv functions will be assessed by FAB (frontal assessment battery)
Time Frame
at inclusion
Title
executive functions
Description
executiv functions will be assessed by FAB (frontal assessment battery)
Time Frame
at 3 months after inclusion
Title
executive functions
Description
executiv functions will be assessed by FAB (frontal assessment battery)
Time Frame
at 6 months after inclusion
Title
executive functions (FAB)
Description
executiv functions will be assessed by FAB (frontal assessment battery) giving a score
Time Frame
at inclusion
Title
executive functions (FAB)
Description
executiv functions will be assessed by FAB (frontal assessment battery) giving a score
Time Frame
at 3 months after inclusion
Title
executive functions (FAB)
Description
executiv functions will be assessed by FAB (frontal assessment battery) giving a score
Time Frame
at 6 months after inclusion
Title
executive functions (TMT)
Description
executiv functions will be assessed by TMT (frontal assessment battery) - giving a score
Time Frame
at inclusion
Title
executive functions (TMT)
Description
executiv functions will be assessed by TMT (frontal assessment battery) - giving a score
Time Frame
at 3 months after inclusion
Title
executive functions (TMT)
Description
executiv functions will be assessed by TMT (frontal assessment battery) - giving a score
Time Frame
at 6 months after inclusion
Title
cardiovascular performance
Description
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
Time Frame
at inclusion
Title
cardiovascular performance
Description
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
Time Frame
at 3 months after inclusion
Title
cardiovascular performance
Description
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
Time Frame
at 6 months after inclusion
Title
power - physical condition
Description
physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
Time Frame
at inclusion
Title
power - physical condition
Description
physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
Time Frame
at 3 months after inclusion
Title
power - physical condition
Description
physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score
Time Frame
at 6 months after inclusion
Title
strenght - physical condition
Description
physical condition will be asessed by grip strength (hand grip) with a score
Time Frame
at inclusion
Title
strenght - physical condition
Description
physical condition will be asessed by grip strength (hand grip) with a score
Time Frame
at 3 months after inclusion
Title
strenght - physical condition
Description
physical condition will be asessed by grip strength (hand grip) with a score
Time Frame
at 6 months after inclusion
Title
evaluation of quality of life
Description
quality of life will be assessed by SF 12 a short version of the MEDICAL OUTCOME STUDY SHORT FORME GENERAL HEALTH SURVEY (score)
Time Frame
at inclusion
Title
evaluation of quality of life
Description
quality of life will be assessed by SF 12 a short version of the MEDICAL OUTCOME STUDY SHORT FORME GENERAL HEALTH SURVEY (score)
Time Frame
at 3 months after inclusion
Title
evaluation of quality of life
Description
quality of life will be assessed by SF 12 a short version of the MEDICAL OUTCOME STUDY SHORT FORME GENERAL HEALTH SURVEY (score)
Time Frame
at 6 months after inclusion
Title
anxiety and depression
Description
anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score
Time Frame
at inclusion
Title
anxiety and depression
Description
anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score
Time Frame
at 3 months after inclusion
Title
anxiety and depression
Description
anxiety and depression will be assessed by the HADS " Hospital Anxiety and Depression Scale " and giving a score
Time Frame
at 6 months after inclusion
Title
apathy
Description
apathy will be assessed by the apathy inventory questionnary and givig a score
Time Frame
at inclusion
Title
apathy
Description
apathy will be assessed by the apathy inventory questionnary and givig a score
Time Frame
at 3 months after inclusion
Title
apathy
Description
apathy will be assessed by the apathy inventory questionnary and givig a score
Time Frame
at 6 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justine Lemaire
Phone
33492034778
Email
lemaire.j@chu-nice.fr
Facility Information:
Facility Name
Nice University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine Lemaire
Phone
33492034778
Email
lemaire.j@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Guillaume Sacco, PH
Phone
33492034778
Email
sacco.g@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Guillaume SACCO, PH

12. IPD Sharing Statement

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Adapted Physical Activity Education in Patients With Neurocognitive Disorder

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