非転移性乳がん女性における血管機能に対する有酸素運動プログラムの効果評価
非転移性乳癌女性における有酸素運動プログラムの血管機能への影響評価
The goal of this clinical trial is to assess the feasibility of an 8-week aerobic exercise program and its effect on arterial function in breast cancer survivors.
The main questions it aims to answer are:
- Is an 8-week aerobic exercise program feasible in breast cancer survivors after the completion of chemotherapy, immunotherapy and/or anti-HER2 agents?
- Is this 8-week aerobic exercise program beneficial for vascular function in breast cancer survivors?
Participants will:
- Begin an 8-week aerobic exercise program, three days per week, after the completion of chemotherapy, immunotherapy and/or anti-HER2 agents.
- Visit our facility three times: before the exercise program, 1 month after, and after the completion of the program.
- Complete questionnaires, physical functional tests, and body composition and vascular measurements at every visit.
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
研究連絡先
- 名前：Georgios Grigoriadis, PhD
- 電話番号：773-508-3658
- メール：ggrigoriadis@luc.edu
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:
- Women (18-70 years) with a stage I-III breast cancer diagnosis who have completed chemotherapy, immunotherapy and/or anti-HER2 agents.
- Able to begin aerobic exercise within 12 weeks of the final chemotherapy, immunotherapy and/or anti-HER2 agents.
- Sedentary by self-reporting inactivity (<90 min of moderate or vigorous exercise per week)
- Weight ≤154 kg
- Willing to complete all study activities
- Able to safely participate in moderate aerobic exercise.
Exclusion criteria:
- Current pregnant and lactating patients. Must have completed lactation prior to study start.
- Metastatic disease.
- Diagnosed cardiovascular disease prior to the initiation of cancer therapy, as evidenced by cardiomyopathy (reduced regional or global left ventricular contractility), diastolic dysfunction grade 2 or above, symptomatic coronary artery disease, ejection fraction below 50%.
- Non-English speaking
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：支持療法
- 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 |
|---|---|
|
実験的：運動介入
|
Participants will perform aerobic exercise three times per week for 8 weeks, with each session consisting of 30 minutes at 40-59% of heart rate reserve (HRR). Each session will also include a 10-minute warm-up and a 5-minute cool-down. |
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 |
|---|---|---|
|
Enrollment (Recruitment rate)
時間枠：From enrollment to immediately after first visit
|
Enrollment will be measured by the proportion of eligible breast cancer survivors who provide informed consent to participate in the study. The proportion of enrolled participants will be reported. |
From enrollment to immediately after first visit
|
|
Participant adherence - Proportion of people considered adherent
時間枠：From enrollment to the end of intervention at 8 weeks
|
Adherence will be measured as the proportion of exercise sessions completed by consented survivors out of the total of 24 prescribed training sessions. Completion of at least 18 of the 24 training sessions will be considered adherent. |
From enrollment to the end of intervention at 8 weeks
|
|
Retention - Proportion of survivors who completed the study
時間枠：From enrollment to the end of intervention at 8 weeks
|
Retention will be measured by the percentage of consented survivors that completed the research study compared to the total number initially enrolled. The proportion of survivors who completed the study will be reported. |
From enrollment to the end of intervention at 8 weeks
|
|
Pulse Wave Velocity
時間枠：From enrollment to the end of intervention at 8 weeks"
|
This test measures how stiff your arteries are (called pulse wave velocity). Pulse wave velocity is an important measure that can help predict the risk of heart and blood vessel disease. It is a simple, non-invasive test, which means it does not involve needles or anything that goes inside your body. We will use a device called the SphygmoCor XCEL to do the test. To measure this, we will place a small sensor on your neck (over the carotid artery) and a blood pressure cuff on your upper thigh (over the femoral artery). The cuff will inflate slightly while we record your pulse waves. We will also use a tape measure to find the distance between the two spots. This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention. |
From enrollment to the end of intervention at 8 weeks"
|
|
Aortic Blood Pressure
時間枠：From enrollment to the end of intervention at 8 weeks
|
We will use a simple, non-invasive test to estimate the aortic blood pressure with a device called the SphygmoCor XCEL. The device measures your blood pressure using a cuff placed on your upper arm. Aortic blood pressure is another test we use to check the health of the heart and blood vessels. This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention. |
From enrollment to the end of intervention at 8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood Pressure
時間枠：From enrollment to the end of intervention at 8 weeks
|
Participants will be asked to wear a blood pressure cuff on their arm with a small monitoring recording pack (ABPMpro device). The device will take measurements every 2 minutes. Participants will undergo two blood pressure measurements. If the two measurements are not within 5 mmHg for both systolic and diastolic blood pressure, additional measurements will be obtained until this criterion is satisfied. The blood pressure device gives a reliable measurement of the blood pressure, which is an important way to check your heart and blood vessel health This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention. |
From enrollment to the end of intervention at 8 weeks
|
協力者と研究者
スポンサー
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 219222
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
米国FDA規制機器製品の研究
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。