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

March 11, 2011 updated by: University Hospital, Angers

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49933
        • Recruiting
        • Angers University Hospital
        • Contact:
        • Principal Investigator:
          • Cedric Annweiler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients of Angers University Memory Center, with respect to the eligibility criteria

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Workshop balances (SIEL BLEU Association)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to "Siel Bleu" balance exercices
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Cedric ANNWEILER, MD, University Memory Centre ANGERS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ANTICIPATED)

June 1, 2011

Study Completion (ANTICIPATED)

June 1, 2011

Study Registration Dates

First Submitted

March 11, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (ESTIMATE)

March 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 14, 2011

Last Update Submitted That Met QC Criteria

March 11, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-A01148-49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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