Circle Dance for Family Caregivers of the Elderly With Alzheimer. (CircleCare)
2019年3月21日 更新者：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.
調査の概要
研究の種類
介入
入学 (予想される)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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SP
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Sao Carlos、SP、ブラジル、13566-544
- 募集
- Julimara Gomes dos Santos
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コンタクト：
- Julimara G Santos, PhD
- 電話番号：+5533991132227
- メール：julimaraefi@yahoo.com.br
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
他の名前：
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介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Brazilian Version of the Short Physical Performance Battery
時間枠：Baseline and 12 weeks after randomization.
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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.
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Baseline and 12 weeks after randomization.
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Timed Up and Go Test
時間枠：Baseline and 12 weeks after randomization.
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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.
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Baseline and 12 weeks after randomization.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Addenbrooke's Cognitive Examination-Revised (ACE-R)
時間枠：Baseline and 12 weeks after randomization
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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.
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Baseline and 12 weeks after randomization
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Zarit Burden Interview (ZBI)
時間枠：Baseline and 12 weeks after randomization
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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.
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Baseline and 12 weeks after randomization
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Brazilian Perceived Stress Scale (BPSS-10)
時間枠：Baseline and 12 weeks after randomization
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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.
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Baseline and 12 weeks after randomization
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Geriatric Depression Scale (GDS-15)
時間枠：Baseline and 12 weeks after randomization
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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.
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Baseline and 12 weeks after randomization
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Quality of Life Scale in Alzheimer's disease (QoL-AD - caregiver's version)
時間枠：Baseline and 12 weeks after randomization
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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.
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Baseline and 12 weeks after randomization
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Frailty Phenotype
時間枠：Baseline and 12 weeks after randomization
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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.
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Baseline and 12 weeks after randomization
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Illustrated and Reduced Mood States List (MSL-IR)
時間枠：After randomization, at the beginning and end of the first CircleCare session.
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Scale that evaluates the intensity of positive and negative moods represented by 14 "smile" faces.
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After randomization, at the beginning and end of the first CircleCare session.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年9月6日
一次修了 (予想される)
2019年6月14日
研究の完了 (予想される)
2019年7月1日
試験登録日
最初に提出
2017年3月2日
QC基準を満たした最初の提出物
2017年3月10日
最初の投稿 (実際)
2017年3月16日
学習記録の更新
投稿された最後の更新 (実際)
2019年3月25日
QC基準を満たした最後の更新が送信されました
2019年3月21日
最終確認日
2019年3月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。