Contribution of Physical Activity to Self-esteem and Motivation in Older Adults With Minor to Major Cognitive Disorders Such as Alzheimer's Disease or Related Disorders (APAMA)
Primary Purpose
Cognitive Disorders
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adapted physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Disorders
Eligibility Criteria
Inclusion Criteria:
- Male or Female ≥ 60 years old
- MMSE score between 4 and 26 / 30
- Diagnosis of minor to major NeuroCognitive Disorder of the Alzheimer type or multiple etiology;
- Subject without a major hearing or visual impairment;
- Subject not presenting any contraindications to the practice of adapted physical activity;
- Subject affiliated to Social Security System;
- Signing informed consent
Exclusion Criteria:
- < 60 years
- Medical indications: Recent or unstable cardiovascular events: ECG changes, unstable angina, uncontrolled arrhythmia, 3rd degree BAV, acute heart failure.
- MMSE score < 4
- Subject already engaged in appropriate physical activity
- Subject with a perceptual disorder (AMD, deafness...)
- Subject with a motor disability
- Subject under guardianship, curatorship or safeguard of justice
- Persons deprived of their liberty (administrative or judicial)
Sites / Locations
- Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche du CHU de Nice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adapted physical activity
Arm Description
Patients will participate in an adapted physical activity workshop.
Outcomes
Primary Outcome Measures
Improvement of patient self-esteem
Rosenberg self-esteem scale
Improvement of patient motivation
EAD scale
Improvement of patient apathy
Apathy inventory
Secondary Outcome Measures
Quantitative assessment of physical activity
questionnaire for caregivers
Patient satisfaction
satisfaction questionnaire
Full Information
NCT ID
NCT03866018
First Posted
February 27, 2019
Last Updated
March 5, 2019
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03866018
Brief Title
Contribution of Physical Activity to Self-esteem and Motivation in Older Adults With Minor to Major Cognitive Disorders Such as Alzheimer's Disease or Related Disorders
Acronym
APAMA
Official Title
Contribution of Physical Activity to Self-esteem and Motivation in Older Adults With Minor to Major Cognitive Disorders Such as Alzheimer's Disease or Related Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
August 31, 2019 (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
Alzheimer's disease is the leading cause of dementia in people over 60 years of age. It is characterized by a decline in memory, learning ability and other cognitive domains (language, gnosis, praxis, attention), with a gradual progression of cognitive and behavioral symptoms. Because of the difficulties it causes in carrying out daily living activities, it has a very significant impact on the autonomy of patients suffering from it.
To date, there are various non-drug strategies available to manage these difficulties. Thus, in recent years, more and more studies have shown the benefits that can be gained by several patients care including physical activity, on cognitive function and general quality of life of the elderly people without cognitive impairment but also for patients suffering from Alzheimer's disease or a related pathology.
The objective of this study is to evaluate the effectiveness of adapted physical activity on self-esteem and motivation in patients with neurocognitive disorders. Stimulation groups are proposed within the Claude Pompidou Institute. Within these groups we offer an adapted physical activity program that we have developed in our department. More specifically, it is a study that aims to evaluate the impact of physical activity on the self-esteem and motivation of patients who perform these exercises for 12 weeks, at the rate of one hour per week.
The interest of this study lies in the validation of the effectiveness of such patient care, which would make it possible to promote its dissemination and strengthen the accessibility of this type of non-drug management to elderly people suffering from neurocognitive disorders.
Detailed Description
Alzheimer's disease is the leading cause of dementia in people over 60 years of age. It is characterized by a decline in memory, learning ability and other cognitive domains (language, gnosis, praxis, attention), with a gradual progression of cognitive and behavioral symptoms. Because of the difficulties it causes in carrying out daily living activities, it has a very significant impact on the autonomy of patients suffering from it.
To date, there are various non-drug strategies available to manage these difficulties. Thus, in recent years, more and more studies have shown the benefits that can be gained by several patients care including physical activity, on cognitive function and general quality of life of the elderly people without cognitive impairment but also for patients suffering from Alzheimer's disease or a related pathology.
The objective of this study is to evaluate the effectiveness of adapted physical activity on self-esteem and motivation in patients with neurocognitive disorders. Stimulation groups are proposed within the Claude Pompidou Institute. Within these groups we offer an adapted physical activity program that we have developed in our department. More specifically, it is a study that aims to evaluate the impact of physical activity on the self-esteem and motivation of patients who perform these exercises for 12 weeks, at the rate of one hour per week.
The interest of this study lies in the validation of the effectiveness of such patient care, which would make it possible to promote its dissemination and strengthen the accessibility of this type of non-drug management to elderly people suffering from neurocognitive disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adapted physical activity
Arm Type
Experimental
Arm Description
Patients will participate in an adapted physical activity workshop.
Intervention Type
Other
Intervention Name(s)
Adapted physical activity
Intervention Description
12 sessions of one hour of adapted physical activity.
Primary Outcome Measure Information:
Title
Improvement of patient self-esteem
Description
Rosenberg self-esteem scale
Time Frame
At 4 months
Title
Improvement of patient motivation
Description
EAD scale
Time Frame
At 4 months
Title
Improvement of patient apathy
Description
Apathy inventory
Time Frame
At 4 months
Secondary Outcome Measure Information:
Title
Quantitative assessment of physical activity
Description
questionnaire for caregivers
Time Frame
At 4 months
Title
Patient satisfaction
Description
satisfaction questionnaire
Time Frame
At 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female ≥ 60 years old
MMSE score between 4 and 26 / 30
Diagnosis of minor to major NeuroCognitive Disorder of the Alzheimer type or multiple etiology;
Subject without a major hearing or visual impairment;
Subject not presenting any contraindications to the practice of adapted physical activity;
Subject affiliated to Social Security System;
Signing informed consent
Exclusion Criteria:
< 60 years
Medical indications: Recent or unstable cardiovascular events: ECG changes, unstable angina, uncontrolled arrhythmia, 3rd degree BAV, acute heart failure.
MMSE score < 4
Subject already engaged in appropriate physical activity
Subject with a perceptual disorder (AMD, deafness...)
Subject with a motor disability
Subject under guardianship, curatorship or safeguard of justice
Persons deprived of their liberty (administrative or judicial)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cindy MENEZ
Phone
+33(0)4.92.03.47.63
Email
menez.c@chu-nice.fr
Facility Information:
Facility Name
Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche du CHU de Nice
City
Nice
ZIP/Postal Code
06100
Country
France
12. IPD Sharing Statement
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Contribution of Physical Activity to Self-esteem and Motivation in Older Adults With Minor to Major Cognitive Disorders Such as Alzheimer's Disease or Related Disorders
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