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Effects of Music and Dance on Cognition, Frailty, and Burden in Elderly Caregivers Living in Rural Communities

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ClinicalTrials.gov Identifier: NCT03068299
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Allan Gustavo Brigola, Universidade Federal de Sao Carlos

Tracking Information
First Submitted Date  ICMJE February 22, 2017
First Posted Date  ICMJE March 1, 2017
Last Update Posted Date May 4, 2018
Actual Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
  • Effects of dance on cognition performance [ Time Frame: Change from Baseline in Addenbrooke's Cognitive Examination at 6 months. ]
    It is expected Dance exerts important positive effects on cognition performance compared to baseline.
  • Effects of dance on frailty [ Time Frame: Change from Baseline in Fried Frailty Criteria at 6 months. ]
    It is expected Dance exerts important positive effects on frailty compared to baseline.
  • Effect of dance on burden [ Time Frame: Change from Baseline in Zarit Burden Interview at 6 months. ]
    It is expected Dance exerts important positive effects on burden compared to baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03068299 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
Effects of HCG on burden [ Time Frame: Change from Baseline in Zarit Burden Interview at 6 months. ]
It is expected Health Care Guidance (HCG) exerts important positive effects on burden compared to baseline.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Music and Dance on Cognition, Frailty, and Burden in Elderly Caregivers Living in Rural Communities
Official Title  ICMJE Effects of Music and Dance on Cognition, Frailty, and Burden in Elderly Caregivers Living in Rural Communities
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).
Detailed Description Sample Variables above described of 58 participants will be measured. The participants will be randomized to the dance group (experimental) and to the health care guidance group (control). The group will be paired by age, sex, and schooling. This study focused on prevention of cognitive performance decline, frailty and burden.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cognitive Decline
  • Memory Loss
  • Frail Elderly Syndrome
  • Burden, Dependency
Intervention  ICMJE
  • Other: Dance
    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.
  • Other: Health care guidance
    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.
Study Arms  ICMJE
  • Experimental: Dance
    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.
    Intervention: Other: Dance
  • Experimental: Health care guidance
    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.
    Intervention: Other: Health care guidance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 24, 2017)
58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2018
Estimated Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Allan G Brigola, Ph.D. +551633725782 allanbrig@gmail.com
Contact: Sofia CI Pavarini, Professor +55163306661 sofiapavarini@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03068299
Other Study ID Numbers  ICMJE 63133316.4.0000.5504
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No participant data will be shared with other research. However, the analyzed results will be published in papers.
Responsible Party Allan Gustavo Brigola, Universidade Federal de Sao Carlos
Study Sponsor  ICMJE Universidade Federal de Sao Carlos
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Allan G Brigola, Ph.D. Universidade Federal de Sao Carlos
PRS Account Universidade Federal de Sao Carlos
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP