Circle Dance for Family Caregivers of the Elderly With Alzheimer. (CircleCare)
21 maart 2019 bijgewerkt door: Julimara Gomes dos Santos, Universidade Federal de Sao Carlos
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.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Verwacht)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
SP
-
Sao Carlos, SP, Brazilië, 13566-544
- Werving
- Julimara Gomes dos Santos
-
Contact:
- Julimara G Santos, PhD
- Telefoonnummer: +5533991132227
- E-mail: julimaraefi@yahoo.com.br
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
50 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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.
Andere namen:
|
|
Geen tussenkomst: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Brazilian Version of the Short Physical Performance Battery
Tijdsspanne: Baseline and 12 weeks after randomization.
|
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
Tijdsspanne: Baseline and 12 weeks after randomization.
|
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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Addenbrooke's Cognitive Examination-Revised (ACE-R)
Tijdsspanne: Baseline and 12 weeks after randomization
|
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.
|
Baseline and 12 weeks after randomization
|
|
Zarit Burden Interview (ZBI)
Tijdsspanne: Baseline and 12 weeks after randomization
|
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.
|
Baseline and 12 weeks after randomization
|
|
Brazilian Perceived Stress Scale (BPSS-10)
Tijdsspanne: Baseline and 12 weeks after randomization
|
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.
|
Baseline and 12 weeks after randomization
|
|
Geriatric Depression Scale (GDS-15)
Tijdsspanne: Baseline and 12 weeks after randomization
|
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.
|
Baseline and 12 weeks after randomization
|
|
Quality of Life Scale in Alzheimer's disease (QoL-AD - caregiver's version)
Tijdsspanne: Baseline and 12 weeks after randomization
|
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.
|
Baseline and 12 weeks after randomization
|
|
Frailty Phenotype
Tijdsspanne: Baseline and 12 weeks after randomization
|
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.
|
Baseline and 12 weeks after randomization
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Illustrated and Reduced Mood States List (MSL-IR)
Tijdsspanne: After randomization, at the beginning and end of the first CircleCare session.
|
Scale that evaluates the intensity of positive and negative moods represented by 14 "smile" faces.
|
After randomization, at the beginning and end of the first CircleCare session.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
6 september 2017
Primaire voltooiing (Verwacht)
14 juni 2019
Studie voltooiing (Verwacht)
1 juli 2019
Studieregistratiedata
Eerst ingediend
2 maart 2017
Eerst ingediend dat voldeed aan de QC-criteria
10 maart 2017
Eerst geplaatst (Werkelijk)
16 maart 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
25 maart 2019
Laatste update ingediend die voldeed aan QC-criteria
21 maart 2019
Laatst geverifieerd
1 maart 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 62112716.8.0000.5504
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .