NCT05799001

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Mar 2023Jul 2026

First Submitted

Initial submission to the registry

March 3, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

March 8, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

2.9 years

First QC Date

March 3, 2023

Last Update Submit

August 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (15)

  • evolution of behavioral problems

    - 8 and 12 months for the experimental group- 12 and 16 months for the control group

  • evaluation of cognitive functions

    - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group

  • autonomy or degree of dependence

    - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group

  • activity frequency of dementia patients

    - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group

  • state of depression

    - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group

  • +10 more secondary outcomes

Study Arms (2)

experimental

EXPERIMENTAL

4 months of dance workshop with a Professional dance teacher

Behavioral: Dance therapy

Control

OTHER

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

Behavioral: Dance therapy

Interventions

Dance therapyBEHAVIORAL

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.

Controlexperimental

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Institutionalized patient (male or female) over 65 years of age ;
  • Patient with behavioral problems, as measured by an NPI-ES ≥ 4 on any item and an NPI-ES impact scale ≥ 3 ;
  • Patient able to mobilize the upper body at a minimum (arms, trunk, head);
  • Possibility of including patients under guardianship or curatorship;
  • Patient affiliated to a social security plan;
  • Obtaining consent from the patient or legal representative.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Pays Craponne

Craponne-sur-Arzon, 43500, France

RECRUITING

Centre Hospitalier Emile Roux

Le Puy-en-Velay, 43000, France

RECRUITING

MeSH Terms

Conditions

Dementia

Interventions

Dance Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CareExercise Movement TechniquesPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Lauriane SEDES, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2023

First Posted

April 5, 2023

Study Start

March 8, 2023

Primary Completion

January 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

August 7, 2025

Record last verified: 2025-08

Locations