Aerobic Exercise Training & the Autonomic System In Patients After Myocardial Infarction or Stroke
The Effect of Aerobic Exercise Training On the Function of the Autonomic System In Patients That Have Suffered Myocardial Infarction or Stroke
The purpose of this study is to examine the effect of Aerobic Physical Activity on the function of the Autonomic System in patients after Myocardial Infarction or Stroke.
A secondary objective is to examine whether it is possible to predict which of the patients will most benefit from physical activity (exercise training), taking into account, genetic factors such as Polymorphism of ACE (Angiotensin Converting Enzyme)
調査の概要
状態
介入・治療
詳細な説明
Imbalance in autonomic cardiovascular function has been shown to increase the risk of ventricular arrhythmias and sudden death in patients with coronary artery disease (CAD), after myocardial infarction and after stroke. Heart rate variability (HRV) reflects the autonomic tone of the heart. Under these conditions there is an increased sympathetic adrenergic tone and reduced parasympathetic activity. The effect of aerobic rehabilitation on the Sympathetic-parasympathetic control has been examined. exercise training alters sympatho-vagal control of heart rate variability (HRV) towards parasympathetic dominance in patients after acute myocardial infarction (MI) and in diabetic patients. To our knowledge, in post-stroke patients this issue hasn't been investigated.
It is known that different people react differently to physical training. There is a difference of opinion in literature concerning the function of Genetic parameters, such as the Polymorphism of ACE (Angiotensin Converting Enzyme), in hemodynamic Reactions following Physical Activity and whether there is a connection between Polymorphism and physical performance..
Objectives To examine the effect of Aerobic Physical Activity on the function of the Autonomic System in patients after Myocardial Infarction or Stroke.
A secondary objective is to examine whether it is possible to predict which of the patients will most benefit from physical activity (exercise training), taking into account, genetic factors such as Polymorphism of ACE (Angiotensin Converting Enzyme)
Research Population The research subjects include a) patients after Myocardial Infarction between the ages 20 - 80 , who underwent percutaneous coronary interventions (PCI), and b) patients after a first Stroke between ages 20 - 80, up to two months after the stroke, with a NIH Stroke Score of 6 - 20 and who are able to cooperate and follow instructions.
Methods Part A This research will examine the effect of Aerobic Physical Activity on the function of the Autonomic Nervous System and on various physiological and clinical factors such as B.P., blood sugar level, tryglycerides, HDL, LDL, CRP and aerobic physical fitness, in 70 cardiac patients who participate in the Heart Rehabilitation Program at the Hadassah Hospital on Mt. Scopus and in 30 post Stroke patients.
Control Group I Includes about 70 cardiac patients and about 30 post Stroke patients, thate will NOT include in the Exercise Training Program and ARE suitable with regards to age, sex, and clinical background.
Group II Includes about 30 healthy individuals, suitable for the research groups with regard to age and sex, and have no known cardio-vascular disease and who will participate in Aerobic Exercise Training Program for 3 months.
At the commencement and end of the research:
Patients in the research and control groups will undergo the following tests:-
- Stress Test
- Measurement of Heart Rate Variability by means of a "Holter" monitor.
- General Blood tests (Triglycerides, HDL, LDL, sugar and HB.A1C.CRP)
- Quality of life according to SF questionnaire.
- B.P and Pulse at rest.
- NIH Stroke Scale
- MAS (Motor Assessment Scale).
- FIM (Functional Independence Scale)
- Walking Speed Test; (the distance covered in two minutes) at a comfortable speed. During the test the patient is connected to a Polar Watch (heart rate monitor) to check the Heart Rate.
Physical (Exercise)Training
- Each patient will receive a personal training program and his optimal heart rate is determined by the results the stress test according to a Borg scale - a scale for assessing, subjectively, the training intensity level. RPE (Rating of perceived exertion scale)
- Duration of program: 3 months, 2 sessions a week, each session lasting 60 minutes.
- Session includes about 15 minutes of warm-up, the main part - aerobic workout on exercise machines for 35 minutes, and relaxation for 10 minutes.
- The main part includes work on the following fitness machines; treadmill, bicycle and arm ergometria.
- The heart rate is monitored constantly during the training, by means of a Polar Watch.
- At the start and end of each session, blood pressure is measured, and if necessary also during the session.
- The intensity of effort will be examined by means of the Borg Scale (RPE) for a subjective assessment of level of difficulty.
Part B Blood tests at the end of the training program will include a test of ACE Insertion/Deletion Polymorphism.
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Ayelet Giladi, MSc
- 電話番号:00 972 3 9793424
- メール:miron@hotmail.co.il
研究連絡先のバックアップ
- 名前:Isabella Schwartz, Dr
- 電話番号:: 00 972 2 5844474
- メール:Isabellas@hadassah.med.org
研究場所
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Jerusalem、イスラエル
- Hadassah Medical Organization, Jerusalem, Israel
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コンタクト:
- Arik Tzukert, DMD
- 電話番号::00 972 2 6776095
- メール:arik@hadassah.org.il
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コンタクト:
- IsabellaHadas Lemberg, PhD
- 電話番号:00 972 2 6777572
- メール:lhadas@hadassah.org.il
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副調査官:
- Ayelet Giladi, Msc
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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: The research subjects include a) patients after Myocardial Infarction between the ages 20 - 80 , who underwent percutaneous coronary interventions (PCI), and b) patients after a first Stroke between ages 20 - 80, up to two months after the stroke, with a NIH Stroke Score of 6 - 20 and who are able to cooperate and follow instructions.:
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Exclusion Criteria:1) Unstable Angina Pectoris2) Valvular Heart disease 3) Cardiomyopathy4) uncontrolled Hypertension.5) Cardiac Insufficiency (uncontrolled)6) uncontrolled arrhythmia 7) Severe Skeletal problems, or other physical, mental or medical problems liable to limit the patient' ability to participate.8) Incompliance.9) Patients who develop symptoms during the research, will be removed.
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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:階乗代入
- マスキング:なし(オープンラベル)
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 |
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HR vriability at 12 weeks
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二次結果の測定
結果測定 |
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B.P., blood sugar level, tryglycerides, HDL, LDL, CRP and aerobic physical fitness,at 12 weeks.
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協力者と研究者
捜査官
- 主任研究者:Isabella Schwartz, Dr、Hadassah Medical Organization
研究記録日
主要日程の研究
研究開始
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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