- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05799001
Dance Workshop for Institutionalized Seniors With Behavioral and Psychological Symptoms of Dementia (APAISE)
It is estimated that the prevalence of dementia in France is 5% for people over 65 years of age and that this increases to 18% for people over 75 years of age. Behavioral disorders are frequent in patients with dementia and are the main cause of institutionalization, representing up to 50% of cases. Dementia syndromes can be translated into behavioral and psychological symptoms of dementia (BPSD), which are defined as perceptual, mood or behavioral disorders. To date, there is no cure for dementia, but certain measures can be taken to reduce symptoms. The HAS suggests that physical exercise would reduce BPSD and could improve the ability to perform activities of daily living or slow down the cognitive decline of this type of patient. Indeed, several articles have highlighted the benefits of physical activity in demented patients. A meta-analysis has shown a significant decrease in BPSD via the Neuropsychiatric Inventory (NPI) score. Nevertheless, it is often observed that there is a difficulty in adhering to the program in very elderly population groups. Dance is a complete physical activity that integrates physical, cognitive and social elements. A meta-analysis has shown that dance has a significant effect on global cognition but also on neuroplasticity and physical functioning in patients with mental disorders. The music component of dance also has an effect on the behavioral problems of demented patients, stimulating language ability and social and emotional function.
However, at present, no study of good methodological quality has been able to demonstrate the effectiveness of dance-based physical activity for the treatment of dementia symptoms. As a result of these findings, the APAISE project was developed and should help slow the onset of BPSD in patients with dementia.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cécile CHAPPUIS
- Phone Number: 0471041545
- Email: cecile.chappuis@ch-lepuy.fr
Study Contact Backup
- Name: Lauriane SEDES, PhD
- Phone Number: 0471043127
- Email: lauriane.sedes@ch-lepuy.fr
Study Locations
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Craponne-sur-Arzon, France, 43500
- Recruiting
- Centre Hospitalier Pays Craponne
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Contact:
- Sophie LENGAGNE
- Phone Number: 0471053526
- Email: sophie.lengagne@ch-lepuy.fr
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Principal Investigator:
- Elodie FOURNIER
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Institutionalized patient (male or female) over 65 years of age ;
- Patient with behavioral problems, as measured by an NPI-ES > 3 on any item and an NPI-ES impact scale > 2 ;
- Patient able to mobilize the upper body at a minimum (arms, trunk, head);
- Medication (antipsychotics, antidepressants, anxiolytics and related hypnotics) without major modification for at least 30 days prior to inclusion after medical advice;
- Possibility of including patients under guardianship or curatorship;
- Patient affiliated to a social security plan;
Obtaining consent from the patient or legal representative.
Exclusion Criteria:
- Inability of the patient to follow the sessions (e.g., major visual/auditory disabilities), difficult follow-up, or any other reason at the discretion of the investigator;
- Inability of the health care team to complete the NPI-ES questionnaire for the patient;
- Patient has a concurrent psychiatric disorder (e.g., bipolar disorder, schizophrenia, or other).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental
4 months of dance workshop with a Professional dance teacher
|
Patients will be randomized in 2 groups, experimental or control. The experimental group will have 4 months of dance therapy with a professional dancer and will then resume there usual activities. The control group will start with their usual activities in the nursing home for the first 4 months and then, they will have dance sessions with a nurse previously trained by the dancer. |
Other: Control
First, patients will have usual activities for 4 months and in a second time, they will have 4 months of dance class with a nurse previously trained by the dance teacher
|
Patients will be randomized in 2 groups, experimental or control. The experimental group will have 4 months of dance therapy with a professional dancer and will then resume there usual activities. The control group will start with their usual activities in the nursing home for the first 4 months and then, they will have dance sessions with a nurse previously trained by the dancer. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the effectiveness of adding biweekly dance class for 4 months on behavioral and psychological symptoms of dementia in institutionalized older adults compared to usual care alone.
Time Frame: 4 months
|
The primary endpoint was the overall score on the validated Neuropsychiatric Inventory questionnaire, completed by the health care teams.
This questionnaire will be done at inclusion (day 0) and after 4 months of dance therapy for the experimental group or usual care alone for the control group.This questionnaire allows to highlight behavioral disorders in patients suffering from dementia according to 10 behavioral domains and 2 neurovegetative variables (sleep and appetite).
|
4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIPH2_CHAPPUIS_APAISE
- 2022-A02335-38 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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