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

U

University Hospital, Angers

Status

Unknown

Conditions

Alzheimer Disease
Gait Apraxia
Impaired Cognition

Treatments

Other: Workshop balances

Study type

Observational

Funder types

Other

Identifiers

NCT01314638
2009-A01148-49

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

100 participants in 1 patient group

Single group
Description:
Single group, Identical investigations for all subjects
Treatment:
Other: Workshop balances

Trial contacts and locations

1

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Central trial contact

Cédric ANNWEILER, MD

Data sourced from clinicaltrials.gov

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