Circle Dance for Family Caregivers of the Elderly With Alzheimer.

NCT ID: NCT03081533

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-06

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Family Caregiver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The assessors will be blind to groups allocation (experimental and control group).

Study Groups

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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.

Group Type EXPERIMENTAL

Circle Dance Program (CircleCare)

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Dance

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role lead

Responsible Party

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Julimara Gomes dos Santos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Julimara Gomes dos Santos

São Carlos, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Julimara G Santos, PhD Student

Role: CONTACT

+5533991132227

Facility Contacts

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Julimara G Santos, PhD

Role: primary

+5533991132227

Other Identifiers

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62112716.8.0000.5504

Identifier Type: -

Identifier Source: org_study_id

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