Cognitive DeclineNCT03068299
Effects of Music and Dance on Cognition, Frailty, and Burden in Elderly Caregivers Living in Rural Communities
A study testing Dance and Health care guidance in people with Cognitive Decline and Memory Loss, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
This research aims to analyze the effects of senior dance on the cognition, frailty, and burden in elderly caregivers of rural communities. This is a randomized clinical trial to be conducted with a sample of 58 elderly caregivers residing in rural communities. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Memory Loss, Frail Elderly Syndrome
- What is being tested?
- Dance and Health care guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2017to 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - Caregivers of elderly registered in Units of Family Health system in rural communities of São Carlos, Brazil.
- - Over 60 years old.
- - Living rural area.
Who cannot join
- 1 - Sufficient sensory or language difficulties that impede the participation of the intervention and the measurement of the variables
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of São Carlos
São Carlos, São Paulo, 13565-905
Sofia CI Pavarini, Professor, 551633066661, sofia@ufscar.br
Fernanda Moura, MSc
About this study
This research aims to analyze the effects of senior dance on the cognition, frailty, and burden in elderly caregivers of rural communities. This is a randomized clinical trial to be conducted with a sample of 58 elderly caregivers residing in rural communities. Data collection will be performed in the homes of the elderly and/or in the dependencies of the Family Health units (USFs - primary health care systems). They will answer Socio-demographic characterization instrument, ACE-R Battery, and electroencephalography for cognitive evaluation, five Fragility criteria proposed by Fried et al and Zarit Burden Inventory. The dance protocol will be applied to the experimental group (n=29) in the USFs and the control group (n=29) will receive health care, including guidance on health care and practices. The protocols include 24 interventions, 60 minutes each, weekly, during 6 months. Analysis of effects comparisons will be conducted between groups and be comparing baseline with final measurements. Dance intervention is expected to exert important positive effects on all study variables (cognitive performance, fragility assessment, and caregiver burden), compared to the group. The intervention of the control group is expected to exert positive effects on some variables of the study (mainly, caregiver burden).
Read the detailed description
Sample Variables above described of 58 participants will be measured. The participants will be randomized to the dance group (experimental) and to the health care guidance group (control). The group will be paired by age, sex, and schooling. This study focused on prevention of cognitive performance decline, frailty and burden.
- Being tested
- Dance, Health care guidance
- Keywords
- Prevention, Cognition, Aged care, Caregivers, Frail elderly, Dancing therapy, Rural population
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanceOther
Sessions of sixty minutes each, which will take place weekly, totaling 24 weeks (6 months). Ten minutes from the start of each session will be reserved for initial exercises, with movements of the upper limbs, lower, accompanied by a motivational music. The process of identifying and memorizing the movements will be carried out as many times as the group deems necessary. The rhythms include combinations of circular and ballroom dances, including waltz, cha-cha-cha, cancan, among others. In all the sessions, the last fifteen minutes are reserved for a conversation about the dance learned/practiced in the day. It is expected to have reached the proposal of a practice of 15 different choreographies and that this was a pleasant moment for all the participants.
Health care guidanceOther
Control group will receive attention, through guidelines for care and health practices for the caregiver and the elderly care recipient. This attention should occur in the same number of sessions of the dance and group intervention group. The control group should follow the same subdivision of the intervention group, in terms of the number of participants per subgroup. The subjects of the guidelines will be raised by the demand of the participants themselves and then worked in an interdisciplinary way.
| Study group | Role | What they receive |
|---|---|---|
| Dance | Experimental | n=29 participants randomized. Cognition performance, frailty and burden will be measured at baseline and after of interventions (6 months after baseline). Instruments of measurement described in Time Frame. Receives: Other: Dance |
| Health care guidance | Experimental | n=29 participants randomized. Cognition performance, frailty and burden will be measured at baseline and after of interventions (6 months after baseline). Instruments of measurement described in Time Frame. Receives: Other: Health care guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of dance on cognition performance
It is expected Dance exerts important positive effects on cognition performance compared to baseline.
Measured: Change from Baseline in Addenbrooke's Cognitive Examination at 6 months.
Effects of dance on frailty
It is expected Dance exerts important positive effects on frailty compared to baseline.
Measured: Change from Baseline in Fried Frailty Criteria at 6 months.
Effect of dance on burden
It is expected Dance exerts important positive effects on burden compared to baseline.
Measured: Change from Baseline in Zarit Burden Interview at 6 months.
Secondary outcomes (1)
Effects of HCG on burden
It is expected Health Care Guidance (HCG) exerts important positive effects on burden compared to baseline.
Measured: Change from Baseline in Zarit Burden Interview at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start1 Oct 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- Model description
- The dance protocol will be applied to the experimental group (n=29) in the USFs and the control group (n=29) will receive health care, including guidance on health care and practices
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allan Gustavo Brigola, Universidade Federal de Sao Carlos
- Investigators
- Allan G Brigola, Ph.D., Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068299
- Sponsor's protocol ID
- 63133316.4.0000.5504
- Status last verified
- May 2018
- First submitted
- 22 Feb 2017
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No participant data will be shared with other research. However, the analyzed results will be published in papers.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music and Dance on Cognition, Frailty, and Burden in Elderly Caregivers Living in Rural Communities
- ClinicalTrials.gov ID
- NCT03068299
- Acronym / sponsor ID
- 63133316.4.0000.5504
- Keywords
- Prevention, Cognition, Aged care, Caregivers, Frail elderly, Dancing therapy, Rural population
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 1 Mar 2017 (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 research aims to analyze the effects of senior dance on the cognition, frailty, and burden in elderly caregivers of rural communities. This is a randomized clinical trial to be conducted with a sample of 58 elderly caregivers residing in rural communities. Data collection will be performed in the homes of the elderly and/or in the dependencies of the Family Health units (USFs - primary health care systems). They will answer Socio-demographic characterization instrument, ACE-R Battery, and electroencephalography for cognitive evaluation, five Fragility criteria proposed by Fried et al and Zarit Burden Inventory. The dance protocol will be applied to the experimental group (n=29) in the USFs and the control group (n=29) will receive health care, including guidance on health care and practices. The protocols include 24 interventions, 60 minutes each, weekly, during 6 months. Analysis of effects comparisons will be conducted between groups and be comparing baseline with final measurements. Dance intervention is expected to exert important positive effects on all study variables (cognitive performance, fragility assessment, and caregiver burden), compared to the group. The intervention of the control group is expected to exert positive effects on some variables of the study (mainly, caregiver burden).
Detailed description
Sample Variables above described of 58 participants will be measured. The participants will be randomized to the dance group (experimental) and to the health care guidance group (control). The group will be paired by age, sex, and schooling. This study focused on prevention of cognitive performance decline, frailty and burden.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The dance protocol will be applied to the experimental group (n=29) in the USFs and the control group (n=29) will receive health care, including guidance on health care and practices
| Arm | Type | Receives |
|---|---|---|
| Dance | Experimental | Other: Dancen=29 participants randomized. Cognition performance, frailty and burden will be measured at baseline and after of interventions (6 months after baseline). Instruments of measurement described in Time Frame. |
| Health care guidance | Experimental | Other: Health care guidancen=29 participants randomized. Cognition performance, frailty and burden will be measured at baseline and after of interventions (6 months after baseline). Instruments of measurement described in Time Frame. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - Caregivers of elderly registered in Units of Family Health system in rural communities of São Carlos, Brazil.
- - Over 60 years old.
- - Living rural area.
Key exclusion criteria (1 listed)
- 1 - Sufficient sensory or language difficulties that impede the participation of the intervention and the measurement of the variables
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 |
|---|---|---|
| DanceSessions of sixty minutes each, which will take place weekly, totaling 24 weeks (6 months). Ten minutes from the start of each session will be reserved for initial exercises, with movements of the upper limbs, lower, accompanied by a motivational music. The process of identifying and memorizing the movements will be carried out as many times as the group deems necessary. The rhythms include combinations of circular and ballroom dances, including waltz, cha-cha-cha, cancan, among others. In all the sessions, the last fifteen minutes are reserved for a conversation about the dance learned/practiced in the day. It is expected to have reached the proposal of a practice of 15 different choreographies and that this was a pleasant moment for all the participants. | Other | Dance |
| Health care guidanceControl group will receive attention, through guidelines for care and health practices for the caregiver and the elderly care recipient. This attention should occur in the same number of sessions of the dance and group intervention group. The control group should follow the same subdivision of the intervention group, in terms of the number of participants per subgroup. The subjects of the guidelines will be raised by the demand of the participants themselves and then worked in an interdisciplinary way. | Other | Health care guidance |
Primary outcome
Effects of dance on cognition performance
Time frame: Change from Baseline in Addenbrooke's Cognitive Examination at 6 months.
It is expected Dance exerts important positive effects on cognition performance compared to baseline.
Effects of dance on frailty
Time frame: Change from Baseline in Fried Frailty Criteria at 6 months.
It is expected Dance exerts important positive effects on frailty compared to baseline.
Effect of dance on burden
Time frame: Change from Baseline in Zarit Burden Interview at 6 months.
It is expected Dance exerts important positive effects on burden compared to baseline.
1 secondary outcome
Effects of HCG on burden
Time frame: Change from Baseline in Zarit Burden Interview at 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Individual participant dataSharing planned: No. No participant data will be shared with other research. However, the analyzed results will be published in papers.
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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.
Allan G Brigola, Ph.D. principal investigator
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance and Health care guidance in people with Cognitive Decline and Memory Loss, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 May 2018. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allan G Brigola, Ph.D. (+551633725782, allanbrig@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of dance on cognition performance (time frame: Change from Baseline in Addenbrooke's Cognitive Examination at 6 months.). The study lists 3 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 4 May 2018.