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

NCT ID: NCT01314638

Last Updated: 2011-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-06-30

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.

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.

Conditions

Gait Apraxia; Alzheimer Disease; Impaired Cognition

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single group

Single group, Identical investigations for all subjects

Workshop balances

Intervention Type: OTHER

one workshop per week for 20 weeks. Evaluation before and after.

Interventions

Workshop balances

one workshop per week for 20 weeks. Evaluation before and after.

Intervention Type: OTHER

Other Intervention Names

Workshop balances (SIEL BLEU Association)

Eligibility 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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

University Hospital, Angers

Principal Investigators

Cedric ANNWEILER, MD

Role: PRINCIPAL_INVESTIGATOR

University Memory Centre ANGERS

Locations

Angers University Hospital

Angers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Cédric ANNWEILER, MD

Role: CONTACT

ceannweiler@chu-angers.fr

(+33) 241354550

Facility Contacts

Cedric ANNWEILER, MD

Role: primary

ceannweiler@chu-angers.fr

(+33)241354550

Other Identifiers

2009-A01148-49

Identifier Type: -

Identifier Source: org_study_id