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RecruitingNCT05799001APAISEUpdated Aug 7, 2025

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

An interventional study of Dance therapy in Dementia, sponsored by Centre Hospitalier Emile Roux. Recruiting at 2 sites in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-08-07.

Sponsored by Centre Hospitalier Emile Roux · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jan 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dementia

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03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's planned enrollment of 180 is above the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Centre Hospitalier Emile Roux is the lead sponsor of 20 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Institutionalized patient (male or female) over 65 years of age ;
  2. Patient with behavioral problems, as measured by an NPI-ES ≥ 4 on any item and an NPI-ES impact scale ≥ 3 ;
  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

Exclusion Criteria:

  1. 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;
  2. Inability of the health care team to complete the NPI-ES questionnaire for the patient;
  3. Patient has a concurrent psychiatric disorder (e.g., bipolar disorder, schizophrenia, or other).
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    experimental

    4 months of dance workshop with a Professional dance teacher

    Behavioral: Dance therapy

  • 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

    Behavioral: Dance therapy

Interventions

  • BehavioralDance 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.

06

What researchers measure

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).

    Time frame: 4 months

Secondary outcomes

  1. evolution of behavioral problems

    Neuropsychiatric Inventory (NPI-ES) score

    Time frame: - 8 and 12 months for the experimental group- 12 and 16 months for the control group

  2. evaluation of cognitive functions

    Mini Mental State Examination (MMSE) score. The questionnaire consists of 30 items, and each correct answer is worth 1 point. The score must take into account the patient's age and level of education.

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

  3. autonomy or degree of dependence

    Activities of Daily Living (ADL) score. This questionnaire studies the autonomy or degree of dependence of institutionalized patients in carrying out practical activities of daily living: personal hygiene, dressing, going to the toilet, locomotion, continence, eating. It is made up of 6 items, and each item has 3 possible answers. Answers must correspond to the patient's abilities. A total score of 6 indicates maximum patient autonomy.

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

  4. activity frequency of dementia patients

    Activity and Affect Indicators of Quality of Life (AAIQOL) score This questionnaire contains 21 items: 15 items relating to patient activity and 6 items relating to patient affect. The questionnaire highlights decreases in the frequency of activity in institutionalized dementia patients, as well as increases in negative affect and decreases in positive affect, both of which are indicators of worsening dementia.

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

  5. state of depression

    short-Geriatric Depression Scale (short-GDS) score This questionnaire is used to assess depression in the elderly and demented. The short-GDS is a shortened version (15 items) of the GDS (30 items). Each item is answered with a yes or no. Depending on the answer, a value of 0 or 1 is assigned. A total score between 0 and 5 is considered normal, between 5 and 9 indicates probable depression, and a score greater than or equal to 10 almost always indicates the existence of depression.

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

  6. minimal motor and postural possibilities

    Test Moteur Minimum (TMM) score This simple clinical test can be used to assess the minimum motor and postural capabilities of frail elderly subjects. The test assesses postural skills and protective reactions of the upper and lower limbs. Scoring calls for an affirmative or negative response. Each response is assigned a score: if the response is in favor of preserved motor capacity, the score is 1, whereas the score is 0 if the response is in favor of abnormal motor aptitude. This results in an overall score out of 20. The 20 items are divided into 4 themes: - decubitus mobility; - sitting; - standing; - walking. Retropulsion is demonstrated in this test in the sitting, standing and walking positions.

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

  7. collection of drugs

    collected on the medical record : antipsychotics, antidepressants, anxiolytics and related hypnotics

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

  8. program membership

    Refusal rate for participation in dance workshops

    Time frame: 12 months for the experimental group16 months for the control group

  9. program membership

    Rate of premature discharge or lost sight

    Time frame: 12 months for the experimental group16 months for the control group

  10. program membership

    Number of sessions attended by patients.

    Time frame: 12 months for the experimental group16 months for the control group

  11. contribution of dance-based physical activity for trained caregivers

    evaluated by : \- A satisfaction questionnaire

    Time frame: 8, 12 and 16 months

  12. contribution of dance-based physical activity for trained caregivers

    evaluated by : \- Semi-structured interviews

    Time frame: 8, 12 and 16 months

  13. contribution of dance-based physical activity for trained caregivers

    evaluated by : \- Number of sessions realised independently

    Time frame: 8, 12 and 16 months

  14. contribution of dance-based physical activity for trained caregivers

    evaluated by : \- Number of patients attending sessions

    Time frame: 8, 12 and 16 months

  15. contribution of dance-based physical activity for trained caregivers

    evaluated by : \- Frequency of sessions realised.

    Time frame: 8, 12 and 16 months

07

Study locations

2 of 2 sites recruiting
  • Centre Hospitalier Pays Craponne
    Craponne-sur-Arzon, 43500, France
    Recruiting
  • Centre Hospitalier Emile Roux
    Le Puy-en-Velay, 43000, France
    • Cécile CHAPPUIS · Contact · 04 71 04 35 38
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05799001
Lead sponsor
Centre Hospitalier Emile Roux
Responsible party
Sponsor
First posted
Apr 5, 2023
Start date
Mar 8, 2023
Primary completion
Jan 31, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Aug 7, 2025

Study contacts

Cécile CHAPPUIS
Contact
cecile.chappuis@ch-lepuy.fr
0471041545
Lauriane SEDES, PhD
Contact
lauriane.sedes@ch-lepuy.fr
0471043127

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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