NCT01314638

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 14, 2011

Status Verified

March 1, 2011

Enrollment Period

1.1 years

First QC Date

March 11, 2011

Last Update Submit

March 11, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adherence to "Siel Bleu" balance exercices

    baseline

Study Arms (1)

Single group

Single group, Identical investigations for all subjects

Other: Workshop balances

Interventions

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

Also known as: Workshop balances (SIEL BLEU Association)
Single group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angers University Hospital

Angers, 49933, France

RECRUITING

MeSH Terms

Conditions

Gait ApraxiaAlzheimer DiseaseCognition Disorders

Condition Hierarchy (Ancestors)

Gait Disorders, NeurologicNeurologic ManifestationsNervous System DiseasesApraxiasPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Cedric ANNWEILER, MD

    University Memory Centre ANGERS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cédric ANNWEILER, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 14, 2011

Study Start

May 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 14, 2011

Record last verified: 2011-03

Locations