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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05799001
Other study ID # RIPH2_CHAPPUIS_APAISE
Secondary ID 2022-A02335-38
Status Recruiting
Phase N/A
First received
Last updated
Start date March 8, 2023
Est. completion date July 31, 2026

Study information

Verified date May 2023
Source Centre Hospitalier Emile Roux
Contact Cécile CHAPPUIS
Phone 0471041545
Email cecile.chappuis@ch-lepuy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date July 31, 2026
Est. primary completion date January 31, 2026
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. Institutionalized patient (male or female) over 65 years of age ; 2. Patient with behavioral problems, as measured by an NPI-ES > 3 on any item and an NPI-ES impact scale > 2 ; 3. Patient able to mobilize the upper body at a minimum (arms, trunk, head); 4. Medication (antipsychotics, antidepressants, anxiolytics and related hypnotics) without major modification for at least 30 days prior to inclusion after medical advice; 5. Possibility of including patients under guardianship or curatorship; 6. Patient affiliated to a social security plan; 7. Obtaining consent from the patient or legal representative. Exclusion Criteria: 8. 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; 9. Inability of the health care team to complete the NPI-ES questionnaire for the patient; 10. Patient has a concurrent psychiatric disorder (e.g., bipolar disorder, schizophrenia, or other).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Dance therapy
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.

Locations

Country Name City State
France Centre Hospitalier Pays Craponne Craponne-sur-Arzon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Emile Roux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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
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