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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05799001
Acronym
APAISE
Enrollment
180
Registered
2023-04-05
Start date
2023-03-08
Completion date
2026-07-31
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

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.

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.

Sponsors

Centre Hospitalier Emile Roux
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

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).

Design outcomes

Primary

MeasureTime frameDescription
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.4 monthsThe 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

MeasureTime frameDescription
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 groupMini 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.
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 groupActivities 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.
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 groupActivity 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.
state of depression- 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control groupshort-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.
evolution of behavioral problems- 8 and 12 months for the experimental group- 12 and 16 months for the control groupNeuropsychiatric Inventory (NPI-ES) score
collection of drugs- 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control groupcollected on the medical record : antipsychotics, antidepressants, anxiolytics and related hypnotics
program membership12 months for the experimental group16 months for the control groupRefusal rate for participation in dance workshops
contribution of dance-based physical activity for trained caregivers8, 12 and 16 monthsevaluated by : \- A satisfaction questionnaire
minimal motor and postural possibilities- 4 months (for the 2 groups)- 8 and 12 months for the experimental group- 12 and 16 months for the control groupTest 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.

Countries

France

Contacts

Primary ContactCécile CHAPPUIS
cecile.chappuis@ch-lepuy.fr0471041545
Backup ContactLauriane SEDES, PhD
lauriane.sedes@ch-lepuy.fr0471043127

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026