Effects of Combined Aerobic and Resistance Training in Patients With Intermittent Claudication
Effects of Home-based Combined Aerobic and Resistance Training on Walking Capacity, Circulating Endothelial Progenitor Cells AND Endothelial Function in Patients With Intermittent Claudication
Exercise training improves walking capacity and regional perfusion in patients with Intermittent Claudication (IC). Endothelial Progenitor Cells (EPCs) and Endothelial Microparticles (EMPs) could play an important role in this process, promoting the healing of the diseased endothelium.
The investigators are going to measure EPCs and EMPs in a group of patients with IC and in a control group of healthy individuals before a treadmill test and 2, 24, and 48 hours after the test. Subsequently, a group of IC patients will be randomly assigned to perform a 12-week home-based exercise training program.
The investigators expect a significant increase of EMPs and EPCs after acute and chronic physical activity. We expect also a correlation between the increase of EMPs and EPCs and the improvement in walking capacity. Aim of the study is to demonstrate that acutely performed aerobic exercise could be able to promote the mobilization of EMPs and EPCs in patients with IC and that endothelial progenitor cells mobilization could play a pivotal role in exercise induced improvement of walking performance and endothelial function in subjects with IC.
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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PG
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Perugia、PG、イタリア、06132
- Ospedale "Santa Maria della Misericordia" di Perugia
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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:
- history of stable intermittent claudication (PAD, stage II Fontaine)
- resting ankle-brachial index (ABI) <0,9 and the presence of occlusion or significant stenosis at the color-Doppler duplex ultrasound scanning
Exclusion Criteria:
- lower-limb ischemic rest pain or gangrene (Fontaine stages III and IV)
- inability to obtain the ABI value or to perform a walking test
- exercise tolerance limited by factors other than claudication (i.e., arrhythmias, cardiac symptoms or exaggerated blood pressure rise, severe obesity)
- end-stage liver or renal failure
- acute or chronic inflammatory conditions
- history of recent (<6 months) acute coronary syndrome, cerebrovascular event or inducible myocardial ischemia
- treatment with drugs known to affect walking capacity, including calcium-channel blockers, β-blockers and angiotensin-converting enzyme inhibitors.
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：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- 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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介入なし：Healthy control
Voluntary subjects without peripheral arterial disease
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偽コンパレータ：IC patients, no exercise
Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, given advices to perform regular aerobic activity
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general recommendation to perform regular aerobic physical activity
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アクティブコンパレータ：IC patients, exercise
Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, home-based combined physical exercise
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Five training sessions weekly for 12 weeks are scheduled.
Each session lasts 60 minutes divided into 45 minutes of aerobic workout and 15 minutes of circuit training.
The aerobic workout consists of walking on a flat floor or on a slight uphill (maximum slope 3%): patients should walk until submaximal walking capacity (80% of their MWT) and rest as they would experience pain at the lower limbs; afterwards, they should start to walk again, once the pain was improved.
Resistance training consists of calisthenics exercises focused on trunk and lower limbs muscles (bicycle, flutter kicks, squats, lunges, calf raises, wall sits and power press) with at least 3 repetitions for each exercise, interspersed by 30 seconds recovery.
Duration of repetitions increases every 3 weeks.
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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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Endothelial Microparticles (EMPs)
時間枠：week 0 - week 12
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hematological parameter, cells particles released by activated endothelium, measured by cytofluorimetry
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week 0 - week 12
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Endothelial Progenitor Cells (EPCs)
時間枠：week 0 - week 12
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hematological parameter, immature bone-marrow derived cells which repair the damaged endothelium, measured by cytofluorimetry
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week 0 - week 12
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Maximum Walking Time
時間枠：week 0 - week 12
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functional parameter, maximum walking capacity for an individual with IC measured through a treadmill walking test
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week 0 - week 12
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Pain-free Walking Time
時間枠：week 0 - week 12
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maximum walking capacity for an individual with IC without experiencing pain measured through a treadmill walking test
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week 0 - week 12
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Flow-mediated Dilation
時間枠：week 0 - week 12
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ultrasonographic evaluation of endothelial function
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week 0 - week 12
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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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。
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