Study of Adherence and Effects of Balance Exercices (SIEL... | NCT01314638

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

NCT01314638

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Mar 14, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Gait Apraxia
Alzheimer Disease
Impaired Cognition

Interventions

Workshop balances

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jun 2011Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

Mar 11, 2011

First Submission Date that Met QC Criteria

Mar 11, 2011

First Posted Date

Mar 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2011

Last Update Posted Date

Mar 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single group		Single group, Identical investigations for all subjects	Other: Workshop balances

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Workshop balances	Other	one workshop per week for 20 weeks. Evaluation before and after.	Single group

Measure	Description	Time Frame
Adherence to "Siel Bleu" balance exercices		baseline

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cédric ANNWEILER, MD	Contact	(+33) 241354550		ceannweiler@chu-angers.fr

Overall Officials

Name	Affiliation	Role
Cedric ANNWEILER, MD	University Memory Centre ANGERS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Angers University Hospital	Recruiting	Angers		49933	France

Condition Browse Module

MeSH Terms

ID	Term
D020235	Gait Apraxia
D000544	Alzheimer Disease
D003072	Cognition Disorders

Ancestor Terms

ID	Term
D020233	Gait Disorders, Neurologic
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D001072	Apraxias

Browse Leaves

Not provided

Browse Branches

Not provided