Brazilian Circle Dance Program for Family Caregivers of the Elderly With Alzheimer's Disease (CircleCare): a Single-blind, Parallel-group Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Brazilian Version of the Short Physical Performance Battery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessors will be blind to groups allocation (experimental and control group).
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Cardiopulmonary or orthopaedic contraindication to the practice of physical exercise.
- •Severe visual or hearing deficiency that impedes participation in the intervention and assessments.
研究组 & 干预措施
Circle Dance Program (CircleCare)
Caregivers (n=20) allocated to the experimental group will participate in 12-week CircleCare twice a week (24 sessions), for 60 min each session. The planning and conduction of the intervention will be the responsibility of the researcher, a Fitness Professional with training in Circle Dance, called focalizer.
干预措施: Circle Dance Program (CircleCare) (Other)
Control group
Caregivers (n=20) of this group will not receive the intervention, participating only in the assessment protocol. They will be instructed not to initiate any regular exercise program during the study period. At the end of the study, the same CircleCare applied to the experimental group will be offered to the interested of the control group.
结局指标
主要结局
Brazilian Version of the Short Physical Performance Battery
时间窗: Baseline and 12 weeks after randomization.
Battery tests that evaluate the static balance; the speed of gait and lower limb muscle strength. Each test ranges from zero to four points, and the total score is obtained by summing the score of each test, ranging from zero to 12 points. The result can receive the following graduation: 0 to 3 points: incapacity or very poor performance; 4 to 6 points: low performance; 7 to 9 points: moderate performance; 10 to 12 points: good performance.
Timed Up and Go Test
时间窗: Baseline and 12 weeks after randomization.
Test that evaluates the basic functional mobility through the time spent to get up from a chair with arms, walk 3 meters and return to the chair, as well as the number of steps required to perform the activity. The shorter the time to perform the task, the better the mobility index. The 12.47 second cutoff point will be used as an indicator of the risk of falls.
次要结局
- Addenbrooke's Cognitive Examination-Revised (ACE-R)(Baseline and 12 weeks after randomization)
- Zarit Burden Interview (ZBI)(Baseline and 12 weeks after randomization)
- Brazilian Perceived Stress Scale (BPSS-10)(Baseline and 12 weeks after randomization)
- Frailty Phenotype(Baseline and 12 weeks after randomization)
- Geriatric Depression Scale (GDS-15)(Baseline and 12 weeks after randomization)
- Quality of Life Scale in Alzheimer's disease (QoL-AD - caregiver's version)(Baseline and 12 weeks after randomization)
研究者
Julimara Gomes dos Santos
Principal Investigator
Universidade Federal de Sao Carlos