Adapted Physical Activity Education in Patients With Neurocognitive Disorder

Study Overview
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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.

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

Conditions
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Neurocognitive Disorders

Intervention / Treatment
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* Other: APA
* Other: PAE


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: APA (adapted physical activity)<br>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<br>* 24 APA sessions<br>|
| Experimental: APA (adapted physical activity) + physical activity education (PAE)<br>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<br>* 24 APA sessions<br>Other: PAE<br>* 8 individuals sessions of PAE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global cognition | global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score | at inclusion | 
| global cognition | global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score | at 3 months after inclusion | 
| global cognition | global cognition will be assessed by a MMSE test (Mini Mental State Examination) mesured by a score | at 6 months after inclusion | 
| executive functions | executiv functions will be assessed by FAB (frontal assessment battery) | at inclusion | 
| executive functions | executiv functions will be assessed by FAB (frontal assessment battery) | at 3 months after inclusion | 
| executive functions | executiv functions will be assessed by FAB (frontal assessment battery) | at 6 months after inclusion | 
| executive functions (FAB) | executiv functions will be assessed by FAB (frontal assessment battery) giving a score | at inclusion | 
| executive functions (FAB) | executiv functions will be assessed by FAB (frontal assessment battery) giving a score | at 3 months after inclusion | 
| executive functions (FAB) | executiv functions will be assessed by FAB (frontal assessment battery) giving a score | at 6 months after inclusion | 
| executive functions (TMT) | executiv functions will be assessed by TMT (frontal assessment battery) - giving a score | at inclusion | 
| executive functions (TMT) | executiv functions will be assessed by TMT (frontal assessment battery) - giving a score | at 3 months after inclusion | 
| executive functions (TMT) | executiv functions will be assessed by TMT (frontal assessment battery) - giving a score | at 6 months after inclusion | 
| 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 | at inclusion | 
| 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 | at 3 months after inclusion | 
| 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 | at 6 months after inclusion | 
| power - physical condition | physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score | at inclusion | 
| power - physical condition | physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score | at 3 months after inclusion | 
| power - physical condition | physical condition will be asessed by lower extremity power (isokinetic ergometer) with a score | at 6 months after inclusion | 
| strenght - physical condition | physical condition will be asessed by grip strength (hand grip) with a score | at inclusion | 
| strenght - physical condition | physical condition will be asessed by grip strength (hand grip) with a score | at 3 months after inclusion | 
| strenght - physical condition | physical condition will be asessed by grip strength (hand grip) with a score | at 6 months after inclusion | 
| 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) | at inclusion | 
| 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) | at 3 months after inclusion | 
| 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) | at 6 months after inclusion | 
| anxiety and depression | anxiety and depression will be assessed by the HADS  Hospital Anxiety and Depression Scale  and giving a score | at inclusion | 
| anxiety and depression | 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 | anxiety and depression will be assessed by the HADS  Hospital Anxiety and Depression Scale  and giving a score | at 6 months after inclusion | 
| apathy | apathy will be assessed by the apathy inventory questionnary and givig a score | at inclusion | 
| apathy | apathy will be assessed by the apathy inventory questionnary and givig a score | at 3 months after inclusion | 
| apathy | apathy will be assessed by the apathy inventory questionnary and givig a score | at 6 months after inclusion |