Alzheimer Dementia (AD)NCT04113967
Efficacy of a Biodanza Program in People With Alzheimer's Disease.
A study testing Biodanza program in people with Alzheimer Dementia (AD) and Mental Disorder, run by Universidad de Almeria at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Alzheimer Dementia (AD), Mental Disorder, Mood Disorders
- What is being tested?
- Biodanza program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2018to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary diagnosis of Alzheimer's disease,
- never participated in any biodanza session or have knowledge about it.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Biodanza program
- Keywords
- Biodanza, Alzheimer Dementia, dance therapy, complementary therapies, physical activity
- Medical subject headings
- Alzheimer Disease, Mental Disorders, Mood Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodanza programOther
Also called Biodance
Biodanza is a form of intervention aimed at promoting health and well-being through the promotion of self-expression and self-regulation through interaction through music and dance. The music accompanied by the movement of the body induces some experiences that present the ability to modify the organism itself both at an organic level, as affective-motor and existential. This intervention constitutes a means for the correct development of human qualities, whose purpose is to integrate the potentials of bond, health and harmony, as well as to develop new alternatives for the life of each individual.
| Study group | Role | What they receive |
|---|---|---|
| Biodanza Group | Experimental | 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. Receives: Other: Biodanza program |
| Treatment as usual Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated responses of all the systems involved during exercise. The self-paced 6MWT assesses the submaximal level of functional capacity. Because most activities of daily living are performed at submaximal levels of exertion, the 6MWD may better reflect the functional exercise level for daily physical activities.
Measured: 3 months
Tinetti test
The Tinetti-test was published by Mary Tinetti (Yale University) to assess the gait and balance in older adults. It is a very good indicator of the fall risk of an individual. The test requires a hard armless chair, a stopwatch and also, a 15feet even and uniform walkway. It has 2 sections; one assesses balance abilities in a chair and also in standing, and the other assesses dynamic balance during gait on a 15feet walkway.The patient is to sit in an armless chair and will be asked to rise up and stay standing. The patient will then turn 360° and then sit back down.This is to test the patients' balance. Next, the patient will have to walk a few meters at a normal speed, followed by turning and walking back at a "fast but safe" speed. The patient will then sit back down. During this test, the patient can use any assistive devices (walking stick, crutches, zimmer frame) they would normally use.
Measured: 3 months
Mini Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) is a 10-minute measure of impaired thinking. The summed score of the individual items indicates the current severity of cognitive impairment. Deterioration in cognition is indicated by decreasing scores of repeated tests. The items of the MMSE include tests of orientation, registration, recall, calculation and attention, naming, repetition, comprehension, reading, writing and drawing. Level of consciousness is rated on a scale from coma to fully alert, but the consciousness rating is not summed with the other items. If all items are answered correctly, the score is 30. The mean score for a community-dwelling population over 65 years of age is 27, with a standard deviation of 1.71. Alzheimer's disease patients lose 3-4 points per year of illness after the onset of memory disturbance, although there is wide variability in this phenomenon.
Measured: 3 months
Daily Living Activities Index (Barthel Scale/Index)
The Barthel Scale/Index is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL (feeding, personal toileting, bathing, dressing and undressing, getting on and off a toilet, controlling bladder, controlling bowel, moving from wheelchair to bed and returning, walking on level surface, or propelling a wheelchair if unable to walk, and ascending and descending stairs). Each item is rated in terms of whether the patient can perform the task independently, with some assistance, or is dependent on help based on observation (0=unable, 1=needs help, 2=independent). The final score is x 5 to get a number on a 100 point score.
Measured: 3 months
Pfeiffer Short Portable Mental Status Questionnaire
Pfeiffer Test is also known as "short portable mental status questionnaire" and abbreviated as "SPMSQ". This questionnaire is an instrument to assess the organic brain deficit, easy to use, reliable, valid and brief, since it consists of 10 questions. The test Pfeiffer assigns a score from 0 to 10, depending on the amount of incorrect questions answered, assigning one point for each incorrect question. Then, on the basis of the errors made, these 10 questions measure the cognitive deterioration and determine its degree through four levels as follows: (0-2 points) normal, (3-4) light, (5-7 points), moderate and (8-10 points) severe.
Measured: 3 months
Hamilton Depression Rating Scale
The Hamilton Rating Scale for Depression, is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Although the Hamilton Rating Scale for Depression form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.
Measured: 3 months
Pittsburg Sleep Quality Index.
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Mar 2018
- Primary completion1 Jul 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Dementia (AD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María del Mar Lopez-Rodriguez, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113967
- Sponsor's protocol ID
- Universidad de Almería
- Status last verified
- Oct 2019
- First submitted
- 30 Sep 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Biodanza Program in People With Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT04113967
- Acronym / sponsor ID
- Universidad de Almería
- Keywords
- Biodanza, Alzheimer Dementia, dance therapy, complementary therapies, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 3 Oct 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodanza Group | Experimental | Other: Biodanza programThe 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. |
| Treatment as usual Group | No intervention | –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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary diagnosis of Alzheimer's disease,
- never participated in any biodanza session or have knowledge about it.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Biodanza programAlso: BiodanceBiodanza is a form of intervention aimed at promoting health and well-being through the promotion of self-expression and self-regulation through interaction through music and dance. The music accompanied by the movement of the body induces some experiences that present the ability to modify the organism itself both at an organic level, as affective-motor and existential. This intervention constitutes a means for the correct development of human qualities, whose purpose is to integrate the potentials of bond, health and harmony, as well as to develop new alternatives for the life of each individual. | Other | Biodanza Group |
Primary outcome
6-minute walk test
Time frame: 3 months
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated responses of all the systems involved during exercise. The self-paced 6MWT assesses the submaximal level of functional capacity. Because most activities of daily living are performed at submaximal levels of exertion, the 6MWD may better reflect the functional exercise level for daily physical activities.
Tinetti test
Time frame: 3 months
The Tinetti-test was published by Mary Tinetti (Yale University) to assess the gait and balance in older adults. It is a very good indicator of the fall risk of an individual. The test requires a hard armless chair, a stopwatch and also, a 15feet even and uniform walkway. It has 2 sections; one assesses balance abilities in a chair and also in standing, and the other assesses dynamic balance during gait on a 15feet walkway.The patient is to sit in an armless chair and will be asked to rise up and stay standing. The patient will then turn 360° and then sit back down.This is to test the patients' balance. Next, the patient will have to walk a few meters at a normal speed, followed by turning and walking back at a "fast but safe" speed. The patient will then sit back down. During this test, the patient can use any assistive devices (walking stick, crutches, zimmer frame) they would normally use.
Mini Mental State Examination (MMSE)
Time frame: 3 months
The Mini-Mental State Examination (MMSE) is a 10-minute measure of impaired thinking. The summed score of the individual items indicates the current severity of cognitive impairment. Deterioration in cognition is indicated by decreasing scores of repeated tests. The items of the MMSE include tests of orientation, registration, recall, calculation and attention, naming, repetition, comprehension, reading, writing and drawing. Level of consciousness is rated on a scale from coma to fully alert, but the consciousness rating is not summed with the other items. If all items are answered correctly, the score is 30. The mean score for a community-dwelling population over 65 years of age is 27, with a standard deviation of 1.71. Alzheimer's disease patients lose 3-4 points per year of illness after the onset of memory disturbance, although there is wide variability in this phenomenon.
Daily Living Activities Index (Barthel Scale/Index)
Time frame: 3 months
The Barthel Scale/Index is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL (feeding, personal toileting, bathing, dressing and undressing, getting on and off a toilet, controlling bladder, controlling bowel, moving from wheelchair to bed and returning, walking on level surface, or propelling a wheelchair if unable to walk, and ascending and descending stairs). Each item is rated in terms of whether the patient can perform the task independently, with some assistance, or is dependent on help based on observation (0=unable, 1=needs help, 2=independent). The final score is x 5 to get a number on a 100 point score.
Pfeiffer Short Portable Mental Status Questionnaire
Time frame: 3 months
Pfeiffer Test is also known as "short portable mental status questionnaire" and abbreviated as "SPMSQ". This questionnaire is an instrument to assess the organic brain deficit, easy to use, reliable, valid and brief, since it consists of 10 questions. The test Pfeiffer assigns a score from 0 to 10, depending on the amount of incorrect questions answered, assigning one point for each incorrect question. Then, on the basis of the errors made, these 10 questions measure the cognitive deterioration and determine its degree through four levels as follows: (0-2 points) normal, (3-4) light, (5-7 points), moderate and (8-10 points) severe.
Hamilton Depression Rating Scale
Time frame: 3 months
The Hamilton Rating Scale for Depression, is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Although the Hamilton Rating Scale for Depression form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.
Pittsburg Sleep Quality Index.
Time frame: 3 months
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodanza program in people with Alzheimer Dementia (AD) and Mental Disorder, run by Universidad de Almeria at 1 site in Spain.
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 2 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: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: 3 months). The study lists 7 primary outcomes in all. 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 3 Oct 2019.