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Effects of Music and Dance on Cognition, Frailty, and Burden in Elderly Caregivers Living in Rural Communities

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ClinicalTrials.gov Identifier: NCT03068299
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Allan Gustavo Brigola, Universidade Federal de Sao Carlos

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Cognitive Decline Memory Loss Frail Elderly Syndrome Burden, Dependency Other: Dance Other: Health care guidance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Effects of Music and Dance on Cognition, Frailty, and Burden in Elderly Caregivers Living in Rural Communities
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Dance
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.
Other: Dance
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.

Experimental: Health care guidance
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.
Other: Health care guidance
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Effects of HCG on burden [ Time Frame: Change from Baseline in Zarit Burden Interview at 6 months. ]
    It is expected Health Care Guidance (HCG) exerts important positive effects on burden compared to baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. - Caregivers of elderly registered in Units of Family Health system in rural communities of São Carlos, Brazil.
  2. - Over 60 years old.
  3. - Living rural area.

Exclusion Criteria:

1 - Sufficient sensory or language difficulties that impede the participation of the intervention and the measurement of the variables


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068299


Contacts
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Contact: Allan G Brigola, Ph.D. +551633725782 allanbrig@gmail.com
Contact: Sofia CI Pavarini, Professor +55163306661 sofiapavarini@gmail.com

Locations
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Brazil
Federal University of São Carlos Recruiting
São Carlos, São Paulo, Brazil, 13565-905
Contact: Sofia CI Pavarini, Professor    551633066661    sofia@ufscar.br   
Sub-Investigator: Fernanda Moura, MSc         
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Investigators
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Principal Investigator: Allan G Brigola, Ph.D. Universidade Federal de Sao Carlos

Study Data/Documents: Ethics Acceptance letter  This link exits the ClinicalTrials.gov site
Identifier: 63133316.4.0000.5504
Enter with number CAAE box (63133316.4.0000.5504) and access the official document of ethics acceptance letter of study.

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Responsible Party: Allan Gustavo Brigola, Principal Investigator, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT03068299     History of Changes
Other Study ID Numbers: 63133316.4.0000.5504
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No participant data will be shared with other research. However, the analyzed results will be published in papers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allan Gustavo Brigola, Universidade Federal de Sao Carlos:
Prevention
Cognition
Aged care
Caregivers
Frail elderly
Dancing therapy
Rural population
Additional relevant MeSH terms:
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Memory Disorders
Frailty
Cognitive Dysfunction
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms