Gait ApraxiaSIELBLEUNCT01314638
Study of Adherence and Effects of Balance Exercices (SIEL BLEU Associatio)
An observational study of Gait Apraxia and Alzheimer Disease, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gait Apraxia, Alzheimer Disease, Impaired Cognition
- What is being tested?
- Workshop balances
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: All patients of Angers University Memory Center, with respect to the eligibility criteria
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Angers University Hospital
Angers, 49933
Cedric ANNWEILER, MD, (+33)241354550, ceannweiler@chu-angers.fr
Cedric Annweiler, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Workshop balances
- Medical subject headings
- Gait Apraxia, Alzheimer Disease, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workshop balancesOther
Also called Workshop balances (SIEL BLEU Association)
one workshop per week for 20 weeks. Evaluation before and after.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Single group, Identical investigations for all subjects Receives: Other: Workshop balances |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to "Siel Bleu" balance exercices
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMay 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait ApraxiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Cedric ANNWEILER, MD, Principal investigator, University Memory Centre ANGERS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314638
- Sponsor's protocol ID
- 2009-A01148-49
- Acronym
- SIELBLEU
- Status last verified
- Mar 2011
- First submitted
- 11 Mar 2011
- Last updated
- 14 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01314638
- Acronym / sponsor ID
- SIELBLEU / 2009-A01148-49
- Conditions
- Gait Apraxia, Alzheimer Disease, Impaired Cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- May 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Other: Workshop balancesSingle group, Identical investigations for all subjects |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- All patients of Angers University Memory Center, with respect to the eligibility criteria
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Workshop balancesAlso: Workshop balances (SIEL BLEU Association)one workshop per week for 20 weeks. Evaluation before and after. | Other | Single group |
Primary outcome
Adherence to "Siel Bleu" balance exercices
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cedric ANNWEILER, MD principal investigator
University Memory Centre ANGERS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait Apraxia and Alzheimer Disease, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cédric ANNWEILER, MD ((+33) 241354550, ceannweiler@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to "Siel Bleu" balance exercices (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2011.