Clinical trial NCT01314638: Study of Adherence and Effects of Balance Exercices (SIEL BLEU Associatio)
Official title: Etude de l'adhérence et Des Effets Des Ateliers "équilibre Siel Bleu" Sur la Marche, la Cognition, l'Autonomie et l'indépendance Des Sujets Atteints d'Une Maladie d'Alzheimer, et Sur le Fardeau de l'Aidant Principal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gait Apraxia
Alzheimer Disease
Impaired Cognition
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2011-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients of Angers University Memory Center, with respect to the eligibility criteria

Brief summary: The purpose of this study is to measure the adherence to "Siel bleu" balance exercises in patients with Alzheimer's disease, while taking into account the disease stages.

Detailed description: The practice of physical activity, more specifically postural balance exercises, is an intervention that improves gait performance in the elderly. Among patients with Alzheimer's disease, it seems that physical exercice also improves cognitive performance, reduces the loss of autonomy and independence in activities of daily living. All these effects may reduce the caregiver burden.

Despite several initiatives in France, no study has been carried out to test the adherence to postural balance exercises and to examine the benefits on older AD patients and their caregiver.

The main objective of this study is to measure the adherence to "Siel bleu" balance exercises in patients with Alzheimer's disease, while taking into account the disease stages.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Alzheimer's disease (AD) (DSM-IV/NINCDS-ADRDA criteria)
* Age ≥ 65 years old
* Mild AD (Mini-Mental State Examination score between 21 and 25), moderate AD (Mini-Mental State Examination score between 10 and 20) and severe AD (Mini-Mental State Examination score between 3 and 9)
* Able to walk without any aid on 15 meters.
* Near visual acuity ≥ 2
* Absence of severe depression (score of the 15-item Geriatric Depression Scale ≤ 10)
* Written consent form to participate in the study (or trustworthy person or legal representative for severe AD)
* Being affiliated to a social security regime

Exclusion Criteria:

* Musculoskeletal disorders not related to Alzheimer's disease
* Near visual acuity \< 2
* History of cerebrovascular accident or other cerebro-spinal pathology
* Poor workmanship of the written or oral French language
* Refusal to be informed on possible hanging bare anomaly during study
* Score of Mini-Mental State Examination \< 3
* Presence of severe depression (score of the 15-item Geriatric Depression scale \> 10)
* Use of walking aid
* Subject suffering from pre-existing impellent disturbances
* Refusal to participate (or trustworthy person or legal representative)

Primary outcomes:
measure: Adherence to "Siel Bleu" balance exercices
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
Study officials:
affiliation: University Memory Centre ANGERS
name: Cedric ANNWEILER, MD
role: PRINCIPAL_INVESTIGATOR
References: