Study of Adherence and Effects of Balance Exercices (SIEL BLEU Associatio) (SIELBLEU)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Angers.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Angers
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01314638
First received: March 11, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Gait Apraxia Alzheimer Disease Impaired Cognition |
Other: Workshop balances |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by University Hospital, Angers:
Primary Outcome Measures:
- Adherence to "Siel Bleu" balance exercices [ Time Frame: baseline ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Single group
Single group, Identical investigations for all subjects
|
Other: Workshop balances
one workshop per week for 20 weeks. Evaluation before and after.
Other Name: Workshop balances (SIEL BLEU Association)
|
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| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
All patients of Angers University Memory Center, with respect to the eligibility criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314638
Contacts
| Contact: Cédric ANNWEILER, MD | (+33) 241354550 | ceannweiler@chu-angers.fr |
Locations
| France | |
| Angers University Hospital | Recruiting |
| Angers, France, 49933 | |
| Contact: Cedric ANNWEILER, MD (+33)241354550 ceannweiler@chu-angers.fr | |
| Principal Investigator: Cedric Annweiler, MD | |
Sponsors and Collaborators
University Hospital, Angers
Investigators
| Principal Investigator: | Cedric ANNWEILER, MD | University Memory Centre ANGERS |
More Information
No publications provided
| Responsible Party: | ANNWEILER Cédric ; MD, University Hospital, Angers |
| ClinicalTrials.gov Identifier: | NCT01314638 History of Changes |
| Other Study ID Numbers: | 2009-A01148-49 |
| Study First Received: | March 11, 2011 |
| Last Updated: | March 11, 2011 |
| Health Authority: | France: Ministry of Health |
Additional relevant MeSH terms:
|
Alzheimer Disease Apraxias Cognition Disorders Gait Apraxia Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Psychomotor Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Gait Disorders, Neurologic |
ClinicalTrials.gov processed this record on May 23, 2013