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Family CaregiverCircleCareNCT03081533

Circle Dance for Family Caregivers of the Elderly With Alzheimer.

A study testing Circle Dance Program (CircleCare) in people with Family Caregiver, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Family Caregiver
What is being tested?
Circle Dance Program (CircleCare)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
6 Sep 2017to Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Julimara G Santos, PhD Student contact

+5533991132227

julimaraefi@yahoo.com.br

Brazil1 site, 1 recruiting

  • Julimara Gomes dos Santos

    São Carlos, São Paulo, 13566-544

    Julimara G Santos, PhD, +5533991132227, julimaraefi@yahoo.com.br

    Recruiting

Other trials in Brazil

About this study

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

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.

Being tested
Circle Dance Program (CircleCare)
Keywords
Healthy Aging, Family Health, Exercise, Dance Therapy
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Circle Dance Program (CircleCare)Other

    Also called Dance

    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.

Study groups in NCT03081533
Study groupRoleWhat they receive
Circle Dance Program (CircleCare)ExperimentalCaregivers (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.
Receives: Other: Circle Dance Program (CircleCare)
Control groupNo interventionCaregivers (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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 12 weeks after randomization.

  2. 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.

    Measured: Baseline and 12 weeks after randomization.

Secondary outcomes (6)

  1. 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.

    Measured: Baseline and 12 weeks after randomization

  2. 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.

    Measured: Baseline and 12 weeks after randomization

  3. 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.

    Measured: Baseline and 12 weeks after randomization

  4. 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.

    Measured: Baseline and 12 weeks after randomization

  5. 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.

    Measured: Baseline and 12 weeks after randomization

  6. 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.

    Measured: Baseline and 12 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2017
  2. Study start6 Sep 2017
  3. Primary completion14 Jun 2019 (estimated)
  4. Study completionJul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03081533
Sponsor's protocol ID
62112716.8.0000.5504
Acronym
CircleCare
Status last verified
Mar 2019
First submitted
2 Mar 2017
Last updated
25 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Gomes Dos Santos J, de Andrade LP, Cassemiliano G, Santos VRDS, Farche ACS, Carnavale BF, Pedroso RV, Takahashi ACM. Effects of circle dance (CircleCare) on the physical and mental health of women caregivers of older adults with Alzheimer's disease: a randomized controlled study. Geriatr Nurs. 2026 Aug 29;73:104315. doi: 10.1016/j.gerinurse.2026.104315. Online ahead of print.

    PubMed 42667878

Questions about this trial

What is this clinical trial studying?

A study testing Circle Dance Program (CircleCare) in people with Family Caregiver, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Julimara G Santos, PhD Student (+5533991132227, julimaraefi@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brazilian Version of the Short Physical Performance Battery (time frame: Baseline and 12 weeks after randomization.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03081533, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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