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Dance Workshop for Institutionalized Seniors With Behavioral and Psychological Symptoms of Dementia (APAISE)

Primary Purpose

Dementia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dance therapy
Sponsored by
Centre Hospitalier Emile Roux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Centre Hospitalier Pays CraponneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

experimental

Control

Arm Description

4 months of dance workshop with a Professional dance teacher

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 3, 2023
Last Updated
May 4, 2023
Sponsor
Centre Hospitalier Emile Roux
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1. Study Identification

Unique Protocol Identification Number
NCT05799001
Brief Title
Dance Workshop for Institutionalized Seniors With Behavioral and Psychological Symptoms of Dementia
Acronym
APAISE
Official Title
Dance Workshop for Institutionalized Seniors With Behavioral and Psychological Symptoms of Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Emile Roux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
4 months of dance workshop with a Professional dance teacher
Arm Title
Control
Arm Type
Other
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Dance therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile CHAPPUIS
Phone
0471041545
Email
cecile.chappuis@ch-lepuy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Lauriane SEDES, PhD
Phone
0471043127
Email
lauriane.sedes@ch-lepuy.fr
Facility Information:
Facility Name
Centre Hospitalier Pays Craponne
City
Craponne-sur-Arzon
ZIP/Postal Code
43500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie LENGAGNE
Phone
0471053526
Email
sophie.lengagne@ch-lepuy.fr
First Name & Middle Initial & Last Name & Degree
Elodie FOURNIER

12. IPD Sharing Statement

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Dance Workshop for Institutionalized Seniors With Behavioral and Psychological Symptoms of Dementia

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