Prehab-COG: Does Preoperative Exercise Improve Postoperative Cognitive Outcomes? (Prehab-COG)
Prehab-COG: Does Preoperative Exercise Improve Postoperative Cognitive Outcomes? A Pilot Study.
The purpose of this protocol is to evaluate the feasibility and acceptability of a preoperative exercise intervention (Prehabilitation) program, along with intraoperative Electroencephalography (EEG) recordings, and pre and post operative cognitive testing in older patients undergoing a major surgery.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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California
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Stanford、California、アメリカ、94305
- Stanford Healthcare Centers
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults patients (50 years old or older).
- Scheduled to undergo non-cardiac or non-neurological surgery under general anesthesia.
- Plan to be admitted to the hospital after surgery for a minimum of one night.
- ASA physical status classification I to III.
- English or Spanish fluency (Cognitive testing only validated to be used with English or Spanish speakers).
Exclusion Criteria:
- Not able to understand/speak English or Spanish
- Failure to satisfy adequate hearing test with/without hearing aids.
- Visual impairment.
- Unplanned ICU admission after surgery.
- Patients who are undergoing another intervention study that consists of a cognitive or exercise intervention.
- Inability to provide consistent EEG data of sufficient quality, determined at enrollment.
- Subjects with medical conditions including but not limited to: Angina pectoris, Congestive Heart Failure (CHF) that make it dangerous for unsupervised physical activity, cognitive and psychiatric conditions that may affect ability to consent.
- Subjects who have contraindications to unsupervised exercise including but not limited to fall risks, movement disorders, and those who are on ambulatory oxygen therapy.
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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：Moderate Exercise Arm
The participants will undergo the virtual exercise intervention 2xweek for 3-4 weeks prior to surgery, and take cognitive testing with non-invasive EEG recordings at 5-point time (the baseline prior to start of the exercise program, at 2-4 days prior to surgery, during the surgery, post-op, and 30-day post surgery). Participants will also be interviewed after the intervention and after surgery to obtain their feedback on their experience with the study procedures. |
Eligible participants will receive their exercise program, relevant informational material and training. The exercise program will be tailored to the physical fitness of the participants. The 2xweek virtual sessions take 30 minutes each and include guided exercises at mild-moderate intensity. |
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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Evaluate the feasibility of a preoperative home-based exercise intervention program, with intraoperative EEG recording, and pre and post operative cognitive testing, among older patients undergoing major surgery.
時間枠：Maximum 3 months from participant enrollment to end/completion of all study-related tasks.
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Feasibility will be measured by:
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Maximum 3 months from participant enrollment to end/completion of all study-related tasks.
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Evaluate the acceptability of a preoperative home-based exercise intervention program, with intraoperative EEG recording, and pre and post operative cognitive testing, among older patients undergoing major surgery.
時間枠：Maximum 3 months from participant enrollment to end/completion of all study-related tasks.
|
Acceptability will be measured by: 1) Aggregated (mean) Score of Surveyed Participants' Rating Across Each Study-Task (Average score of participants' ratings across study tasks, including exercise program, EEG recording and cognitive testing). |
Maximum 3 months from participant enrollment to end/completion of all study-related tasks.
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Cindy Kin, MD、Stanford University
- 主任研究者：Patrick Purdon, PhD、Stanford University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。