Clinical trial NCT04113967: Efficacy of a Biodanza Program in People With Alzheimer's Disease.
Official title: Efficacy of a Biodanza Program in People With Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Dementia (AD)
Mental Disorder
Mood Disorders
Physically Disabled
Keywords: Biodanza
Alzheimer Dementia
dance therapy
complementary therapies
physical activity
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to know the efficacy of a biodanza program in adults diagnosed with Alzheimer's, and it is a randomized controlled trial where the control group, which maintains its usual treatment, will form a waiting list to perform any of the treatments outside the follow-up period. There will also be a group that will carry out intervention with biodanza.

For the selection of the sample, there will be the participation of different Alzheimer associations and geriatric centers in the province of Almeria. The inclusion criteria will be between 60 and 75 years old, with a primary diagnosis of Alzheimer's disease, and who have never participated in any biodanza session or have knowledge about it. Those whose diagnosis is different from Alzheimer's disease or who suffers from a physical or psychological illness that prevents the execution of the sessions and all who do not participate in at least 75% (9 sessions) of the sessions will be excluded from the study.

The biodanza program will consist of 12 sessions, one per week, during three months. The control group will continue with its usual treatment and activities, without suffering any alteration. A measurement of the groups (control group and biodanza group) will be carried out before the start and after the end of the sessions. The questionnaires and scales administered to the participants include demographical and clinical variables, physical state variables, cognitive variables, and emotional and behavioral variables. Finally, statistical analyzes will be performed using SPSS version 23. In the case of quantitative variables, they will be expressed as mean and standard deviation and, when the variables are of qualitative type, they will be represented by frequency and percentages.

Detailed description: Dementia is considered a severely disabling illness for those who suffer from it and is usually devastating for their family and caregivers. It is a syndrome mainly of a chronic or progressive nature, caused by a series of brain diseases that affect memory, behavior, thinking and ability to perform activities of daily living (WHO, 2013).

This study aims to know the efficacy of a biodanza program in adults diagnosed with Alzheimer's.

This is a randomized controlled trial where the control group, which maintains its usual treatment, will form a waiting list to perform any of the treatments outside the follow-up period. There will also be a group that will carry out intervention with biodanza.

In this study, adults with Alzheimer's disease will participate voluntarily, regardless of race or sex. For the selection of the sample, there will be the participation of different Alzheimer associations and geriatric centers in the province of Almeria. The inclusion criteria will be between 60 and 75 years old, with a primary diagnosis of Alzheimer's disease, and who have never participated in any biodanza session or have knowledge about it. Those whose diagnosis is different from Alzheimer's disease or who suffers from a physical or psychological illness that prevents the execution of the sessions and all who do not participate in at least 75% (9 sessions) of the sessions will be excluded from the study.

In accordance with the principles of the Declaration of Helsinki (2013), before the start of the investigation, participants will be informed and sign consent. Subjects will have the right to refuse to participate as well as to withdraw at any time during the study. They will also be assured of complete confidentiality of the data.

The biodanza program will consist of 12 sessions, one per week, during three months. Each session will last approximately 60 minutes and an introductory phase (10-15 minutes) and an experience phase (45 minutes) will be divided. It involves moving / dancing according to the suggestions of the monitor and the rhythm of the music. The control group will continue with its usual treatment and activities, without suffering any alteration. A measurement of the groups (control group and biodanza group) will be carried out before the start and after the end of the sessions. The questionnaires and scales administered to the participants are classified according to the variables to be measured:

DEMOGRAPHICAL AND CLINICAL VARIABLES, including age, sex, family situation, economic level, nationality, employment status, year of diagnosis of the disease, history of the disease and pharmacological treatment. PHYSICAL STATE VARIABLES, including anthropometric measures such as weight, size, and body mass index (BMI) and physical tests through the 6-minute walk test and Tinetti scale. COGNITIVE VARIABLES, through Mini Mental Status Examination (MMSE), Daily Living Activities Index Barthel, and Pfeiffer Short Portable Mental Status Questionnaire. EMOTIONAL AND BEHAVIORAL VARIABLES, using Hamilton Depression Rating Scale, and Pittsburg Sleep Quality Index.

Finally, statistical analyzes will be performed using SPSS version 23. In the case of quantitative variables, they will be expressed as mean and standard deviation and, when the variables are of qualitative type, they will be represented by frequency and percentages.

Eligibility criteria: Inclusion Criteria:

* primary diagnosis of Alzheimer's disease,
* never participated in any biodanza session or have knowledge about it.

Exclusion Criteria:

* diagnosis is different from Alzheimer's disease
* suffering from a physical or psychological illness that prevents the execution of the sessions
* do not participate in at least 75% (9 sessions) of the sessions.

Primary outcomes:
measure: 6-minute walk test
timeFrame: 3 months
measure: Tinetti test
timeFrame: 3 months
measure: Mini Mental State Examination (MMSE)
timeFrame: 3 months
measure: Daily Living Activities Index (Barthel Scale/Index)
timeFrame: 3 months
measure: Pfeiffer Short Portable Mental Status Questionnaire
timeFrame: 3 months
measure: Hamilton Depression Rating Scale
timeFrame: 3 months
measure: Pittsburg Sleep Quality Index.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Universidad de Almería
Study officials:
References: