Clinical trial NCT03081533: Circle Dance for Family Caregivers of the Elderly With Alzheimer.
Official title: Brazilian Circle Dance Program for Family Caregivers of the Elderly With Alzheimer's Disease (CircleCare): a Single-blind, Parallel-group Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Family Caregiver
Keywords: Healthy Aging
Family Health
Exercise
Dance Therapy
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Universidade Estadual Paulista Júlio de Mesquita Filho
First posted: 2017-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective of this research is to compare the effects of a 12-week CircleCare on physical functioning of family caregivers of the elderly with AD. Effects on cognition, psychosocial and frailty-related aspects (secondary objective). The acute effect of one circle dance session on mood states (tertiary objective). This randomized controlled trial will involve 40 family caregivers over 50 years old allocated into a control group or an intervention group of 12-weeks (twice a week, 60 min per session) of CircleCare. Primary outcomes will include balance, speed of gait, lower limb muscle strength, functional mobility and risk of falls. Secondary outcomes will include cognition, burden, stress, depression, quality of life and frailty. Mood states will be a tertiary outcome. The effects of CircleCare will be verified with an ANOVA two-way test and a multiple comparison test when necessary. The analyzes will follow an intention-to-treat approach. The change in moods will be evaluated by the paired t-test. The level of significance will be set at p\<0.05. This study may guide professionals and health policymakers in deciding whether to implement this type of intervention. If positive effects are demonstrated, this program can be offered in public health services to other groups, given its low cost.


Eligibility criteria: Inclusion Criteria:

* 50 years or older.
* Family caregiver for at least 6 months of an elderly person with Alzheimer's disease.
* Ability to walk without the help of another person.

Exclusion Criteria:

* Cardiopulmonary or orthopaedic contraindication to the practice of physical exercise.
* Severe visual or hearing deficiency that impedes participation in the intervention and assessments.

Primary outcomes:
measure: Brazilian Version of the Short Physical Performance Battery
timeFrame: Baseline and 12 weeks after randomization.
measure: Timed Up and Go Test
timeFrame: Baseline and 12 weeks after randomization.
Secondary outcomes:
measure: Addenbrooke's Cognitive Examination-Revised (ACE-R)
timeFrame: Baseline and 12 weeks after randomization
measure: Zarit Burden Interview (ZBI)
timeFrame: Baseline and 12 weeks after randomization
measure: Brazilian Perceived Stress Scale (BPSS-10)
timeFrame: Baseline and 12 weeks after randomization
measure: Geriatric Depression Scale (GDS-15)
timeFrame: Baseline and 12 weeks after randomization
measure: Quality of Life Scale in Alzheimer's disease (QoL-AD - caregiver's version)
timeFrame: Baseline and 12 weeks after randomization
measure: Frailty Phenotype
timeFrame: Baseline and 12 weeks after randomization
Other outcomes:
measure: Illustrated and Reduced Mood States List (MSL-IR)
timeFrame: After randomization, at the beginning and end of the first CircleCare session.
Locations:
city: Sao Carlos
country: Brazil
facility: Julimara Gomes dos Santos
state: SP
Study officials:
References: