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

Cognitive Decline Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03068299
• Other study ID #: 63133316.4.0000.5504
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: May 2018
• Source: Universidade Federal de Sao Carlos
• Contact: Allan G Brigola, Ph.D.
• Phone: +551633725782
• Email: allanbrig[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Burden, Dependency
• Cognitive Decline
• Cognitive Dysfunction
• Frail Elderly Syndrome
• Memory Disorders
• Memory Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of São Carlos	São Carlos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.