NCT03866018

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

March 7, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

February 27, 2019

Last Update Submit

March 5, 2019

Conditions

Cognitive Disorders

Outcome Measures

Primary Outcomes (3)

  • Improvement of patient self-esteem

    Rosenberg self-esteem scale

    At 4 months

  • Improvement of patient motivation

    EAD scale

    At 4 months

  • Improvement of patient apathy

    Apathy inventory

    At 4 months

Secondary Outcomes (2)

  • Quantitative assessment of physical activity

    At 4 months

  • Patient satisfaction

    At 4 months

Study Arms (1)

Adapted physical activity

EXPERIMENTAL

Patients will participate in an adapted physical activity workshop.

Other: Adapted physical activity

Interventions

Adapted physical activityOTHER

12 sessions of one hour of adapted physical activity.

Adapted physical activity

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \< 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche du CHU de Nice

Nice, 06100, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Cindy MENEZ

CONTACT

+33(0)4.92.03.47.63menez.c@chu-nice.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 7, 2019

Study Start

March 1, 2019

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

March 7, 2019

Record last verified: 2019-02

Locations

FR(1)