Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03866018
Other study ID # 18-AOI-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date August 31, 2019

Study information

Verified date February 2019
Source Centre Hospitalier Universitaire de Nice
Contact Cindy MENEZ
Phone +33(0)4.92.03.47.63
Email menez.c@chu-nice.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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)

Study Design


Intervention

Other:
Adapted physical activity
12 sessions of one hour of adapted physical activity.

Locations

Country Name City State
France Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche du CHU de Nice Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement of patient self-esteem Rosenberg self-esteem scale At 4 months
Primary Improvement of patient motivation EAD scale At 4 months
Primary Improvement of patient apathy Apathy inventory At 4 months
Secondary Quantitative assessment of physical activity questionnaire for caregivers At 4 months
Secondary Patient satisfaction satisfaction questionnaire At 4 months
See also
  Status Clinical Trial Phase
Completed NCT02554253 - The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction Phase 2
Recruiting NCT02777060 - Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures N/A
Completed NCT02342041 - A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 in Healthy Subjects Phase 1
Recruiting NCT01659593 - Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients N/A
Completed NCT01561820 - Mild Cognitive Impairment, Buddy Supported Exercise/ My Buddy Study N/A
Completed NCT00743405 - Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects Phase 1
Completed NCT05373394 - Evaluation of Cognitive and Motor Neurological Disorders in the Short and Long Term After Surgery for the Removal of a Diffuse Low-grade Glioma of the Supplementary Motor Area
Completed NCT04860414 - Prospective Monocentric Study of Taste in Patients With Minor or Major Cognitive Disorders Such as Alzheimer's, Through the Analysis of Gustatory Evoked Potentials. N/A
Completed NCT02324153 - Ramelteon in the Prevention of Post-operative Delirium Phase 2
Completed NCT00458094 - Peer Support for Increasing Physical Activity in People With Serious Mental Illnesses N/A
Completed NCT05486195 - A Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects Including an Assessment of Receptor Occupancy and Food Effect Phase 1
Recruiting NCT02876536 - Effect of Transcutaneous Electrical Nerve Stimulation on Cognition in Multiple Sclerosis Patients N/A
Completed NCT02321475 - EGb 761® (Tanakan®) Effectiveness in the Treatment of Patients of Middle Age and Younger With Psycho-emotional Symptoms, Added to Cognitive Disorders
Completed NCT01881646 - Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery Phase 4
Recruiting NCT05888961 - Single-center Prospective Longitudinal Study of Taste in Patients With Cognitive Disorders at Different Stages of Severity (Isolated Cognitive Complaint, Minor or Major Neurocognitive Alzheimer-type Disorders) by Analysis of Gustatory Evoked Potentials N/A
Completed NCT01983384 - Anesthetic Depth and Postoperative Delirium Trial - 2 N/A
Completed NCT02575482 - A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 in Healthy Subjects Phase 1
Completed NCT00937846 - Brain Uptake of GSK1034702: a Positron Emission Tomography (PET) Scan Study Phase 1
Completed NCT01772095 - ADVANCE Study: Alzheimer Disease eVAluation iN Clinical PracticE N/A
Completed NCT06078332 - Remote Cognitive Multidomain Assessment in People With Cognitive Disorders