Study of Adherence and Effects of Balance Exercices (SIEL BLEU Associatio)

Alzheimer Disease Clinical Trial

— SIELBLEU  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01314638
• Other study ID #: 2009-A01148-49
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2011
• Last updated: March 11, 2011
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: March 2011
• Source: University Hospital, Angers
• Contact: Cédric ANNWEILER, MD
• Phone: (+33) 241354550
• Email: ceannweiler[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Gait Apraxia
• Impaired Cognition

Intervention

Other:
• Workshop balances
one workshop per week for 20 weeks. Evaluation before and after.

Locations

Country	Name	City	State
France	Angers University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to "Siel Bleu" balance exercices		baseline	No