Clinical trial NCT03068299: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Decline
Memory Loss
Frail Elderly Syndrome
Burden, Dependency
Keywords: Prevention
Cognition
Aged care
Caregivers
Frail elderly
Dancing therapy
Rural population
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 58
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Effects of dance on cognition performance
timeFrame: Change from Baseline in Addenbrooke's Cognitive Examination at 6 months.
measure: Effects of dance on frailty
timeFrame: Change from Baseline in Fried Frailty Criteria at 6 months.
measure: Effect of dance on burden
timeFrame: Change from Baseline in Zarit Burden Interview at 6 months.
Secondary outcomes:
measure: Effects of HCG on burden
timeFrame: Change from Baseline in Zarit Burden Interview at 6 months.
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Federal University of São Carlos
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Allan G Brigola, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: