Study of Adherence and Effects of Balance Exercices (SIEL BLEU Associatio)
SIELBLEU
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
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 11, 2011
CompletedFirst Posted
Study publicly available on registry
March 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMarch 14, 2011
March 1, 2011
1.1 years
March 11, 2011
March 11, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Adherence to "Siel Bleu" balance exercices
baseline
Study Arms (1)
Single group
Single group, Identical investigations for all subjects
Interventions
one workshop per week for 20 weeks. Evaluation before and after.
Eligibility Criteria
All patients of Angers University Memory Center, with respect to the eligibility criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Angers University Hospital
Angers, 49933, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cedric ANNWEILER, MD
University Memory Centre ANGERS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
March 11, 2011
First Posted
March 14, 2011
Study Start
May 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
March 14, 2011
Record last verified: 2011-03