Circle Dance for Family Caregivers of the Elderly With Alzheimer. (CircleCare)

Brazilian Circle Dance Program for Family Caregivers of the Elderly With Alzheimer's Disease (CircleCare): a Single-blind, Parallel-group Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Family Caregiver
• Intervention / Treatment: Other: Circle Dance Program (CircleCare)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julimara G Santos, PhD Student; Phone Number: +5533991132227; Email: julimaraefi@yahoo.com.br

Study Locations

• Brazil
  • SP
    • Sao Carlos, SP, Brazil, 13566-544
      • Recruiting
      • Julimara Gomes dos Santos
      • Contact: Julimara G Santos, PhD; Phone Number: +5533991132227; Email: julimaraefi@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Dance
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Universidade Estadual Paulista Júlio de Mesquita Filho

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2017
• Primary Completion (Anticipated): June 14, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Dance Therapy; Healthy Aging; Family Health
• Other Study ID Numbers: 62112716.8.0000.5504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At the end of the study, caregivers will be individually informed about their performance in the assessments, but your personal data will not be shared with others, respecting your privacy and anonymity. However, the analyzed results will be published in papers, reported in congresses and special interest groups such as groups of Alzheimer's caregivers and health units interested in implementing the circle dances as a health promotion activity.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No