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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Gait Apraxia
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Gait Disorders, Neurologic
Neurologic Manifestations
Apraxias
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014