Circle Dance for Family Caregivers of the Elderly With Alzheimer.

Family Caregiver Clinical Trial

— CircleCare  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03081533
• Other study ID #: 62112716.8.0000.5504
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2017
• Est. completion date: July 2019

Study information

• Verified date: March 2019
• Source: Universidade Federal de Sao Carlos
• Contact: Julimara G Santos, PhD Student
• Phone: +5533991132227
• Email: julimaraefi[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Family Caregiver

Intervention

Other:
• Circle Dance Program (CircleCare)
Circle Dances derives from folk dances, but their current repertoire encompasses traditional and contemporary dances from diverse nations and cultures around the world. Most of the choreographies are danced with the participants placed in a circle, holding hands, repeating a pattern of steps to the rhythm of the music.

Locations

Country	Name	City	State
Brazil	Julimara Gomes dos Santos	Sao Carlos	SP

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Illustrated and Reduced Mood States List (MSL-IR)	Scale that evaluates the intensity of positive and negative moods represented by 14 "smile" faces.	After randomization, at the beginning and end of the first CircleCare session.
Primary	Brazilian Version of the Short Physical Performance Battery	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.	Baseline and 12 weeks after randomization.
Primary	Timed Up and Go Test	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.	Baseline and 12 weeks after randomization.
Secondary	Addenbrooke's Cognitive Examination-Revised (ACE-R)	Portuguese version of the Instrument that evaluates the global cognitive function through individual tests of orientation and attention (18 points), memory (26 points), verbal fluency (14 points), language (26 points) and spatial visibility skills (16 points). The overall score ranges from zero to 100 points.	Baseline and 12 weeks after randomization
Secondary	Zarit Burden Interview (ZBI)	An instrument that evaluates the physical, psychological and social impact of the task of caring for a patient with mental illness. The scale is composed of 22 questions, whose scores can range from 0 to 88 points. A score below 21 points is classified as no burden; of 21 and 40 points indicate a moderate burden; between 41 to 60, moderate to severe burden and = 61 points, a severe burden.	Baseline and 12 weeks after randomization
Secondary	Brazilian Perceived Stress Scale (BPSS-10)	PSS-10 is used to assess the level of stress perceived by older adults in the last month. The final score ranges from 0 to 40, with higher scores denoting a greater degree of perceived stress.	Baseline and 12 weeks after randomization
Secondary	Geriatric Depression Scale (GDS-15)	Scale composed of 15 negative/affirmative questions that evaluate the presence of depressive symptoms in the elderly. Scores higher than 5 points indicate the risk of depression.	Baseline and 12 weeks after randomization
Secondary	Quality of Life Scale in Alzheimer's disease (QoL-AD - caregiver's version)	Scale structured in three versions that relate to the quality of life of the elderly, careAn instrument adapted, translated and validated for the Brazilian culture to assess the quality of life of caregivers and elderly with AD. In this version the caregiver to assess his/her own quality of life. The score ranges from 13 to 52 points and the lower the score worse is the quality of life.	Baseline and 12 weeks after randomization
Secondary	Frailty Phenotype	A battery of tests proposed by Fried et al. (2001) that asses unintentional weight loss (10 lbs in the past year), self-reported exhaustion, weakness (grip strength), slow walking speed, and low physical activity. Participants with three or more criteria will be classified as frail. Those with one or two criteria, pre-frail. "No frail" will correspond to the absence of these criteria.	Baseline and 12 weeks after randomization