DementiaAPAISENCT05799001
Dance Workshop for Institutionalized Seniors With Behavioral and Psychological Symptoms of Dementia
A study testing Dance therapy in people with Dementia, run by Centre Hospitalier Emile Roux at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Dance therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Mar 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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);
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Pays Craponne
Craponne-sur-Arzon, 43500
Sophie LENGAGNE, 0471053526, sophie.lengagne@ch-lepuy.fr
Elodie FOURNIER
- Recruiting
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000
Cécile CHAPPUIS, 04 71 04 35 38
About this study
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.
- Conditions
- Dementia
- Being tested
- Dance therapy
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | 4 months of dance workshop with a Professional dance teacher Receives: 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 Receives: Behavioral: Dance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 months
Secondary outcomes (15)
evolution of behavioral problems
Neuropsychiatric Inventory (NPI-ES) score
Measured: - 8 and 12 months for the experimental group- 12 and 16 months for the control group
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.
Measured: - 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
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.
Measured: - 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
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.
Measured: - 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
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.
Measured: - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group
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.
Measured: - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group
collection of drugs
collected on the medical record : antipsychotics, antidepressants, anxiolytics and related hypnotics
Measured: - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group
program membership
Refusal rate for participation in dance workshops
Measured: 12 months for the experimental group16 months for the control group
program membership
Rate of premature discharge or lost sight
Measured: 12 months for the experimental group16 months for the control group
program membership
Number of sessions attended by patients.
Measured: 12 months for the experimental group16 months for the control group
contribution of dance-based physical activity for trained caregivers
evaluated by :
- A satisfaction questionnaire
Measured: 8, 12 and 16 months
contribution of dance-based physical activity for trained caregivers
evaluated by :
- Semi-structured interviews
Measured: 8, 12 and 16 months
contribution of dance-based physical activity for trained caregivers
evaluated by :
- Number of sessions realised independently
Measured: 8, 12 and 16 months
contribution of dance-based physical activity for trained caregivers
evaluated by :
- Number of patients attending sessions
Measured: 8, 12 and 16 months
contribution of dance-based physical activity for trained caregivers
evaluated by :
- Frequency of sessions realised.
Measured: 8, 12 and 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start8 Mar 2023
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Emile Roux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799001
- Sponsor's protocol ID
- RIPH2_CHAPPUIS_APAISE
- Other IDs
- 2022-A02335-38
- Acronym
- APAISE
- Status last verified
- Aug 2025
- First submitted
- 3 Mar 2023
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dance Workshop for Institutionalized Seniors With Behavioral and Psychological Symptoms of Dementia
- ClinicalTrials.gov ID
- NCT05799001
- Acronym / sponsor ID
- APAISE / RIPH2_CHAPPUIS_APAISE
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centre Hospitalier Emile RouxUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: Dance therapy4 months of dance workshop with a Professional dance teacher |
| Control | Other | Behavioral: Dance therapyFirst, 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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);
- 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;
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance therapyPatients 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. | Behavioural | Control, experimental |
Primary outcome
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).
15 secondary outcomes
evolution of behavioral problems
Time frame: - 8 and 12 months for the experimental group- 12 and 16 months for the control group
evaluation of cognitive functions
Time frame: - 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
Time frame: - 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
Time frame: - 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
Time frame: - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group
minimal motor and postural possibilities
Time frame: - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group
collection of drugs
Time frame: - 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control group
program membership
Time frame: 12 months for the experimental group16 months for the control group
program membership
Time frame: 12 months for the experimental group16 months for the control group
program membership
Time frame: 12 months for the experimental group16 months for the control group
contribution of dance-based physical activity for trained caregivers
Time frame: 8, 12 and 16 months
contribution of dance-based physical activity for trained caregivers
Time frame: 8, 12 and 16 months
contribution of dance-based physical activity for trained caregivers
Time frame: 8, 12 and 16 months
contribution of dance-based physical activity for trained caregivers
Time frame: 8, 12 and 16 months
contribution of dance-based physical activity for trained caregivers
Time frame: 8, 12 and 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance therapy in people with Dementia, run by Centre Hospitalier Emile Roux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cécile CHAPPUIS (0471041545, cecile.chappuis@ch-lepuy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.