Long Term Effect of High-intensity Training After Heart Transplantation
High-intensity training (HIT) has repeatedly been documented to have superior positive effects compared to moderate exercise in patients with coronary heart disease and heart failure. Since heart transplant recipients (HTx), have a denervated heart with different respond to exercise, HIT has previously not been introduced among these patients. Rikshospitalet carried out a RCT to investigate this (the TEX study 2009-2012), and found that this form of exercise also was highly effective and safe in long term HTx with clinically significant improvement in VO2peak, muscular exercise capasity, general HRQoL, and even slower progression of CAV (coronary allograft vasculopathy). Based on these findings we ask the following questions in this follow-up study:
- Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study period continue during long term follow up (5 years)?
- Is the intervention group more physical active after HIT compared to the control group?
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Oslo、ノルウェー、0424
- OUS- Rikshospitalet
-
-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- stable situation
- optimal medical treatment
- written concent
Exclusion Criteria:
- unstable situation,
- infections (open wounds or skin diseases),
- physical conditions that prevents participation,
- or other injuries/ diseases who are contraindicated with training.
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
コホートと介入
グループ/コホート |
---|
Intervention group
Group that followed high- intensity interval training program in TEX study.
|
Control group
Followed up on a regular basis for HTx recipients in Norway.
|
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 |
---|---|---|
mean VO2peak in the intervention group and control group
時間枠:5 years after start of inclusion in RCT (TEX). One measurment.
|
We will use the same test protocol as the TEX- study.
|
5 years after start of inclusion in RCT (TEX). One measurment.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
How many has progression of cardiac allograft vasculopathy in the intervention group and control group.
時間枠:5 years after inclusion in RCT (TEX study).
|
Progression of vasculopathy will be studied with IVUS technique, and compared with IVUS pictures from TEX.
|
5 years after inclusion in RCT (TEX study).
|
Mean muscle capacity in the intervention group and control group.
時間枠:5 years after inclusion in RCT, TEX study.
|
5 years after inclusion in RCT, TEX study.
|
|
Quality of life
時間枠:5 years after inclusion in TEX- study.
|
We will use validated questionnaires to estimate quality of life and to evaluate depression.
|
5 years after inclusion in TEX- study.
|
Difference in activity level between groups
時間枠:5 years after inclusion i RCT, TEX study.
|
To estimate activity the study population will fill out a validated questionnaire about physical activity, and they will wear a physical activity monitor at home for one week.
|
5 years after inclusion i RCT, TEX study.
|
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:Lars Gullestad, professor、OUS- kardiologisk avdeling
出版物と役立つリンク
一般刊行物
- Nytroen K, Rustad LA, Aukrust P, Ueland T, Hallen J, Holm I, Rolid K, Lekva T, Fiane AE, Amlie JP, Aakhus S, Gullestad L. High-intensity interval training improves peak oxygen uptake and muscular exercise capacity in heart transplant recipients. Am J Transplant. 2012 Nov;12(11):3134-42. doi: 10.1111/j.1600-6143.2012.04221.x. Epub 2012 Aug 17.
- Nytroen K, Rustad LA, Gude E, Hallen J, Fiane AE, Rolid K, Holm I, Aakhus S, Gullestad L. Muscular exercise capacity and body fat predict VO(2peak) in heart transplant recipients. Eur J Prev Cardiol. 2014 Jan;21(1):21-9. doi: 10.1177/2047487312450540. Epub 2012 Jun 1.
- Nytroen K, Myers J, Chan KN, Geiran OR, Gullestad L. Chronotropic responses to exercise in heart transplant recipients: 1-yr follow-up. Am J Phys Med Rehabil. 2011 Jul;90(7):579-88. doi: 10.1097/PHM.0b013e31821f711d.
- Nytroen K, Rustad LA, Erikstad I, Aukrust P, Ueland T, Lekva T, Gude E, Wilhelmsen N, Hervold A, Aakhus S, Gullestad L, Arora S. Effect of high-intensity interval training on progression of cardiac allograft vasculopathy. J Heart Lung Transplant. 2013 Nov;32(11):1073-80. doi: 10.1016/j.healun.2013.06.023. Epub 2013 Jul 29.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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
本研究に関する用語
その他の研究ID番号
- 2014/872/REK sør-øst C
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。
心臓移植レシピエントの臨床試験
-
Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)