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

Primary Purpose

Cognitive Decline, Memory Loss, Frail Elderly Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dance
Health care guidance
Sponsored by
Universidade Federal de Sao Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline focused on measuring Prevention, Cognition, Aged care, Caregivers, Frail elderly, Dancing therapy, Rural population

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Federal University of São CarlosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dance

Health care guidance

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Effects of dance on cognition performance
It is expected Dance exerts important positive effects on cognition performance compared to baseline.
Effects of dance on frailty
It is expected Dance exerts important positive effects on frailty compared to baseline.
Effect of dance on burden
It is expected Dance exerts important positive effects on burden compared to baseline.

Secondary Outcome Measures

Effects of HCG on burden
It is expected Health Care Guidance (HCG) exerts important positive effects on burden compared to baseline.

Full Information

First Posted
February 22, 2017
Last Updated
May 1, 2018
Sponsor
Universidade Federal de Sao Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT03068299
Brief Title
Effects of Music and Dance on Cognition, Frailty, and Burden in Elderly Caregivers Living in Rural Communities
Official Title
Effects of Music and Dance on Cognition, Frailty, and Burden in Elderly Caregivers Living in Rural Communities
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Memory Loss, Frail Elderly Syndrome, Burden, Dependency
Keywords
Prevention, Cognition, Aged care, Caregivers, Frail elderly, Dancing therapy, Rural population

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dance
Arm Type
Experimental
Arm Description
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.
Arm Title
Health care guidance
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dance
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Health care guidance
Intervention Description
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 Measure Information:
Title
Effects of dance on cognition performance
Description
It is expected Dance exerts important positive effects on cognition performance compared to baseline.
Time Frame
Change from Baseline in Addenbrooke's Cognitive Examination at 6 months.
Title
Effects of dance on frailty
Description
It is expected Dance exerts important positive effects on frailty compared to baseline.
Time Frame
Change from Baseline in Fried Frailty Criteria at 6 months.
Title
Effect of dance on burden
Description
It is expected Dance exerts important positive effects on burden compared to baseline.
Time Frame
Change from Baseline in Zarit Burden Interview at 6 months.
Secondary Outcome Measure Information:
Title
Effects of HCG on burden
Description
It is expected Health Care Guidance (HCG) exerts important positive effects on burden compared to baseline.
Time Frame
Change from Baseline in Zarit Burden Interview at 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Caregivers of elderly registered in Units of Family Health system in rural communities of São Carlos, Brazil. - Over 60 years old. - Living rural area. Exclusion Criteria: 1 - Sufficient sensory or language difficulties that impede the participation of the intervention and the measurement of the variables
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allan G Brigola, Ph.D.
Phone
+551633725782
Email
allanbrig@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia CI Pavarini, Professor
Phone
+55163306661
Email
sofiapavarini@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan G Brigola, Ph.D.
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of São Carlos
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13565-905
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia CI Pavarini, Professor
Phone
551633066661
Email
sofia@ufscar.br
First Name & Middle Initial & Last Name & Degree
Fernanda Moura, MSc

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No participant data will be shared with other research. However, the analyzed results will be published in papers.
Available IPD and Supporting Information:
Available IPD/Information Type
Ethics Acceptance letter
Available IPD/Information URL
http://plataformabrasil.saude.gov.br/login.jsf
Available IPD/Information Identifier
63133316.4.0000.5504
Available IPD/Information Comments
Enter with number CAAE box (63133316.4.0000.5504) and access the official document of ethics acceptance letter of study.

Learn more about this trial

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

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