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

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ClinicalTrials.gov Identifier: NCT01314638
Recruitment Status : Unknown
Verified March 2011 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : March 14, 2011
Last Update Posted : March 14, 2011
Sponsor:
Information provided by:
University Hospital, Angers

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.

Condition or disease Intervention/treatment
Gait Apraxia Alzheimer Disease Impaired Cognition Other: Workshop balances

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.


Study Type : Observational
Estimated Enrollment : 100 participants
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
Study Start Date : May 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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)



Primary Outcome Measures :
  1. Adherence to "Siel Bleu" balance exercices [ Time Frame: baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ANNWEILER Cédric ; MD, University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01314638     History of Changes
Other Study ID Numbers: 2009-A01148-49
First Posted: March 14, 2011    Key Record Dates
Last Update Posted: March 14, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Alzheimer Disease
Apraxias
Cognitive Dysfunction
Gait Apraxia
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Psychomotor Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cognition Disorders
Gait Disorders, Neurologic