NCT03068299

Brief Summary

This research aims to analyze the effects of senior dance on the cognition, frailty, and burden in elderly caregivers of rural communities. This is a randomized clinical trial to be conducted with a sample of 58 elderly caregivers residing in rural communities. Data collection will be performed in the homes of the elderly and/or in the dependencies of the Family Health units (USFs - primary health care systems). They will answer Socio-demographic characterization instrument, ACE-R Battery, and electroencephalography for cognitive evaluation, five Fragility criteria proposed by Fried et al and Zarit Burden Inventory. The dance protocol will be applied to the experimental group (n=29) in the USFs and the control group (n=29) will receive health care, including guidance on health care and practices. The protocols include 24 interventions, 60 minutes each, weekly, during 6 months. Analysis of effects comparisons will be conducted between groups and be comparing baseline with final measurements. Dance intervention is expected to exert important positive effects on all study variables (cognitive performance, fragility assessment, and caregiver burden), compared to the group. The intervention of the control group is expected to exert positive effects on some variables of the study (mainly, caregiver burden).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

February 22, 2017

Last Update Submit

May 1, 2018

Conditions

Keywords

PreventionCognitionAged careCaregiversFrail elderlyDancing therapyRural population

Outcome Measures

Primary Outcomes (3)

  • Effects of dance on cognition performance

    It is expected Dance exerts important positive effects on cognition performance compared to baseline.

    Change from Baseline in Addenbrooke's Cognitive Examination at 6 months.

  • Effects of dance on frailty

    It is expected Dance exerts important positive effects on frailty compared to baseline.

    Change from Baseline in Fried Frailty Criteria at 6 months.

  • Effect of dance on burden

    It is expected Dance exerts important positive effects on burden compared to baseline.

    Change from Baseline in Zarit Burden Interview at 6 months.

Secondary Outcomes (1)

  • Effects of HCG on burden

    Change from Baseline in Zarit Burden Interview at 6 months.

Study Arms (2)

Dance

EXPERIMENTAL

n=29 participants randomized. Cognition performance, frailty and burden will be measured at baseline and after of interventions (6 months after baseline). Instruments of measurement described in Time Frame.

Other: Dance

Health care guidance

EXPERIMENTAL

n=29 participants randomized. Cognition performance, frailty and burden will be measured at baseline and after of interventions (6 months after baseline). Instruments of measurement described in Time Frame.

Other: Health care guidance

Interventions

DanceOTHER

Sessions of sixty minutes each, which will take place weekly, totaling 24 weeks (6 months). Ten minutes from the start of each session will be reserved for initial exercises, with movements of the upper limbs, lower, accompanied by a motivational music. The process of identifying and memorizing the movements will be carried out as many times as the group deems necessary. The rhythms include combinations of circular and ballroom dances, including waltz, cha-cha-cha, cancan, among others. In all the sessions, the last fifteen minutes are reserved for a conversation about the dance learned/practiced in the day. It is expected to have reached the proposal of a practice of 15 different choreographies and that this was a pleasant moment for all the participants.

Dance

Control group will receive attention, through guidelines for care and health practices for the caregiver and the elderly care recipient. This attention should occur in the same number of sessions of the dance and group intervention group. The control group should follow the same subdivision of the intervention group, in terms of the number of participants per subgroup. The subjects of the guidelines will be raised by the demand of the participants themselves and then worked in an interdisciplinary way.

Health care guidance

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Caregivers of elderly registered in Units of Family Health system in rural communities of São Carlos, Brazil.
  • \- Over 60 years old.
  • \- Living rural area.

You may not qualify if:

  • Sufficient sensory or language difficulties that impede the participation of the intervention and the measurement of the variables

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Carlos

São Carlos, São Paulo, 13565-905, Brazil

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionMemory Disorders

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Allan G Brigola, Ph.D.

    Universidade Federal de Sao Carlos

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan G Brigola, Ph.D.

CONTACT

Sofia CI Pavarini, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The dance protocol will be applied to the experimental group (n=29) in the USFs and the control group (n=29) will receive health care, including guidance on health care and practices
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2017

First Posted

March 1, 2017

Study Start

October 1, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

May 4, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

No participant data will be shared with other research. However, the analyzed results will be published in papers.

Available IPD Datasets

Ethics Acceptance letter (63133316.4.0000.5504)Access

Locations