Effect of Exercise on Patients With Claudication Undergoing Surgery
A Randomised Controlled Trial to Analyse the Histological, Physiological and Haemorrheological Adaptations to Supervised Exercise Training in Claudicants
Title: How does exercise improve the calf muscle in patients with poor blood supply to their leg?
Purpose of the project: Patients with peripheral arterial disease have a poor blood supply to their lower leg. The reduced inflow prevents the leg from utilising nutrients and oxygen as easily as a healthy leg would. This causes pain when walking (intermittent claudication), which often occurs after a reproducible distance e.g. every 50 yards. These patients have a reduction in their quality of life as they feel embarrassed in social situations e.g. walking around town requires multiple breaks, so they tend to avoid this and isolate themselves more.
One treatment for claudication is exercising until the pain comes on; which most are reluctant to do. Walking up to three times a week for an hour, can double most people's walking distances, but doesn't always. The reason why some improve with exercise and others do not remains unknown.
This project will be the first randomised controlled trial of exercise in claudicants that focuses on the adaptations that occur in the muscle at a cellular level. We wish to compare muscle cells from a group that have exercised and group that have not. We will focus on the change in muscle cell size and function at present, and later progress to why and how this happens.
Methods: We will take measurements at the start of the study (baseline), after 6 weeks and then 3, 6 and 12 months. These measurements will be of a patient's fitness, actual walking distances and blood samples. At the time of surgery, muscle from the calf will be taken from the affected leg. This will be processed at the University's biomedical science department to look at the different types of muscle fibre and how efficiently they are working.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Hull、イギリス、HU3 2JZ
- 募集
- Hull Royal Infirmary
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コンタクト：
- Romesh Sarvanandan, MBBS MRCS
- 電話番号：01482674643
- メール：romesh1985@doctors.org.uk
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主任研究者：
- Romesh Sarvanandan, MBBS MRCS
-
-
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:
- Community dwelling older adults aged 45 and over
- Diagnosis of intermittent claudication - ABPI < 0.9 with symptoms in keeping with intermittent claudication
- Undergoing surgery for claudication
- Ability to walk without assistance
- Healthy control patients who are undergoing varicose vein surgery
Exclusion Criteria:
- Participants who are unable to provide informed consent
- Severe of acute cardiovascular, musculoskeletal or pulmonary illness
- Critical limb ischaemia
- Active treatment for cancer
- Rheumatoid arthritis or any patient receiving steroids or disease modifying Antirheumatic drugs (DMARDS)
- Failure to complete a CPET
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：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：Supervised Exercise Program
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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 |
|---|---|---|
|
Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care
時間枠：6 weeks
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Patients will undergo cardiopulmonary exercise testing to assess whether a 6 week exercise programme improves the cardiovascular fitness
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6 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measure the changes in muscle fibre type with exercise training or standard care
時間枠：Baseline, 6 weeks, 3 months, 6 months, and 12 months
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Histological analysis to measure the percentage of different types of muscle fibres, and how these are affected by 6 weeks of exercise compared to standard treatment.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months
|
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Measurement of endothelial function after a period or exercise therapy or standard care
時間枠：Baseline, 6 weeks, 3 months, 6 months, and 12 months
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To identify if 6 weeks of exercise improves the endothelial function.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months
|
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Measurement of inflammatory markers with exercise treatment or standard care
時間枠：Baseline, 6 weeks, 3 months, 6 months, and 12 months
|
To identify whether 6 weeks of exercise therapy improves inflammatory markers
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Baseline, 6 weeks, 3 months, 6 months, and 12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Romesh Sarvanandan, MBBS MRCS、Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust
研究記録日
主要日程の研究
研究開始
一次修了 (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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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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