ラテン系高齢者の認知的健康、心血管の健康、睡眠を促進するための身体活動介入
2024年2月6日 更新者：Gloria Adriana Perez、University of Pennsylvania
この研究は、中程度の強度の身体活動を促進するように設計されたマルチレベルの介入、Tiempo Juntos para la Salud（健康のための時間）をテストする無作為化、単盲検、対照試験です。理論的に根拠のあるメディエーター;心血管の健康、睡眠、認知機能の副次的結果。
参加者は、1 年間に 4 回訪問します。
データ収集は、ベースライン、3 か月、6 か月、および 12 か月で、55 歳以上の軽度認知障害 (MCI) [モントリオール認知評価 (MoCA) スコアが 23 から 26 のラテン系住民集団] を持つ 216 人のスペイン語が優勢なラテン系アメリカ人の間で行われます。
調査の概要
研究の種類
介入
入学 (実際)
236
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。
研究連絡先
- 名前：Gloria A Perez, PhD, CRNP
- 電話番号：215-746-1840
- メール：adrianag@nursing.upenn.edu
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania School of Nursing
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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
53年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- インフォームドコンセントを提供できる
- 55歳以上
- ヒスパニック/ラテン系であると自認する
- 第一言語としてのスペイン語
- 介入/教育セッションに参加したい
- 電話/携帯電話へのアクセス
- 週に 150 分未満の活動 (座りっぱなし)
- モントリオール認知評価 (MoCA) スコア (ラテン系集団のスコア ≥ 23 ～ 26)
除外基準:
- インフォームドコンセントを提供できない
- 移動障害
- 筋骨格系の問題/併存症（中等度のPAを防ぐ）
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
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：ティエンポ・フントス介入
このグループに割り当てられた場合、参加者は毎週 1 時間のグループ セッションに週 2 回、3 か月間参加します。
セッションは、トレーニングを受けたコミュニティ ヘルス ワーカーと一緒に行われ、グループ (5 ～ 6 人の参加者) の中程度の強度のウォーキングが含まれます。
すべての参加者が参加できる時間帯に、コミュニティ パートナー サイトで開催されます。
悪天候の場合は、コミュニティ パートナーを通じて屋内の場所を利用できます。
ウォーキングは参加者の目標と能力を反映し、最初は 10 分間続き、5 分間のストレッチ「ウォームアップ」と 5 分間の「クールダウン」エクササイズを合計 20 分間行います。
1 時間のセッション内での歩行時間の増加に対応するために、プログラム コンテンツの配信時間を減らしながら、歩行時間を 5 分 / 週ずつ増やして少なくとも 30 分にします。
3 か月の身体活動セッションを完了すると、次の 3 か月間、電話やテキスト メッセージで隔週でモチベーションを高める「ブースター」セッションが提供されます。
|
このグループに割り当てられた場合、参加者は毎週 1 時間のグループ セッションに週 2 回、3 か月間参加します。
セッションは、トレーニングを受けたコミュニティ ヘルス ワーカーと一緒に行われ、グループ (5 ～ 6 人の参加者) の中程度の強度のウォーキングが含まれます。
3 か月の身体活動セッションを完了すると、次の 3 か月間、電話やテキスト メッセージで隔週でモチベーションを高める「ブースター」セッションが提供されます。
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介入なし：注意制御
このグループに割り当てられた場合、参加者は 1 時間のグループ セッション (参加者 5 ～ 6 名) に週 2 回、3 か月間参加します。
セッションは、成人の健康に関連する教育トピックをスペイン語で確認することを含む、訓練を受けたコミュニティ ヘルス ワーカーまたは資格のあるスタッフと一緒に行われます。
すべての参加者が参加できる時間帯に、コミュニティ パートナー サイトまたはリモートで開催されます。
悪天候の場合は、屋内の場所、またはリモートのオプションを利用できます。
3 か月の教育セッションを完了すると、次の 3 か月間、電話/テキスト メッセージで隔週で教育的な「ブースター」セッションが配信されます。
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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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3 か月時の身体活動頻度のベースラインからの変化
時間枠：12週間
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活動回数
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12週間
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6 か月時の身体活動頻度のベースラインからの変化
時間枠：24週間
|
活動回数
|
24週間
|
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12 か月時の身体活動頻度のベースラインからの変化
時間枠：48週間
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活動回数
|
48週間
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3 か月時の身体活動強度のベースラインからの変化
時間枠：12週間
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軽度、中程度、または活発 (1 分あたりのカウント数で決定)
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12週間
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6 か月時の身体活動強度のベースラインからの変化
時間枠：24週間
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軽度、中程度、または活発 (1 分あたりのカウント数で決定)
|
24週間
|
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12 か月時の身体活動強度のベースラインからの変化
時間枠：48週間
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軽度、中程度、または活発 (1 分あたりのカウント数で決定)
|
48週間
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3 か月のベースラインの身体活動期間からの変化
時間枠：12週間
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アクティビティに費やされた合計時間 (時間と分)
|
12週間
|
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6 か月のベースライン身体活動期間からの変化
時間枠：24週間
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アクティビティに費やされた合計時間 (時間と分)
|
24週間
|
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12 か月のベースライン身体活動期間からの変化
時間枠：48週間
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アクティビティに費やされた合計時間 (時間と分)
|
48週間
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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。
捜査官
- 主任研究者：Gloria A Perez, PhD, CRNP、University of Pennsylvania
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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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)
2021年8月27日
一次修了 (推定)
2024年10月31日
研究の完了 (推定)
2024年12月31日
試験登録日
最初に提出
2021年7月30日
QC基準を満たした最初の提出物
2021年8月26日
最初の投稿 (実際)
2021年9月1日
学習記録の更新
投稿された最後の更新 (実際)
2024年2月7日
QC基準を満たした最後の更新が送信されました
2024年2月6日
最終確認日
2024年2月1日
詳しくは
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。
ティエンポ・フントス介入の臨床試験
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University of MichiganNational Institute on Drug Abuse (NIDA)募集
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Boston Medical CenterDeborah Munroe Noonan Memorial Research Fund募集
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University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺
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Munich Municipal HospitalTechnical University of Munich; University of Regensburgわからない