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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by University Hospital, Angers.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01314638
First Posted: March 14, 2011
Last Update Posted: March 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Angers
March 11, 2011
March 14, 2011
March 14, 2011
May 2010
June 2011   (Final data collection date for primary outcome measure)
Adherence to "Siel Bleu" balance exercices [ Time Frame: baseline ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Adherence and Effects of Balance Exercices (SIEL BLEU Associatio)
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
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
All patients of Angers University Memory Center, with respect to the eligibility criteria
  • Gait Apraxia
  • Alzheimer Disease
  • Impaired Cognition
Other: Workshop balances
one workshop per week for 20 weeks. Evaluation before and after.
Other Name: Workshop balances (SIEL BLEU Association)
Single group
Single group, Identical investigations for all subjects
Intervention: Other: Workshop balances
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
June 2011
June 2011   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01314638
2009-A01148-49
Yes
Not Provided
Not Provided
ANNWEILER Cédric ; MD, University Hospital, Angers
University Hospital, Angers
Not Provided
Principal Investigator: Cedric ANNWEILER, MD University Memory Centre ANGERS
University Hospital, Angers
March 2011