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

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).

Study Overview

• Status: Unknown
• Conditions: Frail Elderly Syndrome; Cognitive Decline; Burden, Dependency; Memory Loss
• Intervention / Treatment: Other: Dance; Other: Health care guidance

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 Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allan G Brigola, Ph.D.; Phone Number: +551633725782; Email: allanbrig@gmail.com
• Study Contact Backup: Name: Sofia CI Pavarini, Professor; Phone Number: +55163306661; Email: sofiapavarini@gmail.com

Study Locations

• Brazil
  • São Paulo
    • São Carlos, São Paulo, Brazil, 13565-905
      • Recruiting
      • Federal University of São Carlos
      • Contact: Sofia CI Pavarini, Professor; Phone Number: 551633066661; Email: sofia@ufscar.br
      • Sub-Investigator: Fernanda Moura, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of dance on cognition performance	It is expected Dance exerts important positive effects on cognition performance compared to baseline.	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.	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.	Change from Baseline in Zarit Burden Interview at 6 months.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Investigators: Principal Investigator: Allan G Brigola, Ph.D., Universidade Federal de Sao Carlos

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Prevention; Cognition; Caregivers; Frail elderly; Aged care; Dancing therapy; Rural population
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Frailty; Memory Disorders
• Other Study ID Numbers: 63133316.4.0000.5504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No participant data will be shared with other research. However, the analyzed results will be published in papers.

Study Data/Documents

1. Ethics Acceptance letter
   Information identifier: 63133316.4.0000.5504
   Information comments: Enter with number CAAE box (63133316.4.0000.5504) and access the official document of ethics acceptance letter of study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No