Circle Dance for Family Caregivers of the Elderly With Alzheimer.

NCT03081533 | Unknown

• 1 other identifier: 62112716.8.0000.5504
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Family Caregiver

Keywords

Healthy Aging; Family Health; Exercise; Dance Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

• 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

Other Outcomes (1)

• Illustrated and Reduced Mood States List (MSL-IR)

  After randomization, at the beginning and end of the first CircleCare session.

Study Arms (2)

Circle Dance Program (CircleCare)

EXPERIMENTAL

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)

Control group

NO INTERVENTION

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.

Interventions

Circle Dance Program (CircleCare) OTHER

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.

Also known as: Dance

Circle Dance Program (CircleCare)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Universidade Estadual Paulista Júlio de Mesquita Filho: collaborator

Study Sites (1)

Julimara Gomes dos Santos

São Carlos, São Paulo, 13566-544, Brazil

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Julimara G Santos, PhD Student

CONTACT

+5533991132227; julimaraefi@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors will be blind to groups allocation (experimental and control group).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 16, 2017
• Study Start: September 6, 2017
• Primary Completion: June 14, 2019
• Study Completion: July 1, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)