|
イハラ トシコ
Toshiko Ito-Ihara
猪原 登志子 所属 川崎医科大学 医学部 応用医学 先端医療開発学 職種 教授 |
|
| 論文種別 | 原著 |
| 言語種別 | 英語 |
| 査読の有無 | 査読あり |
| 表題 | Establishment of optimal exercise therapy using near-infrared spectroscopy monitoring of tissue muscle oxygenation after therapeutic angiogenesis for patients with critical limb ischemia: A multicenter, randomized, controlled trial. |
| 掲載誌名 | 正式名：Contemporary clinical trials communications 略 称：Contemp Clin Trials Commun ISSNコード：24518654/24518654 |
| 掲載区分 | 国外 |
| 巻・号・頁 | 17,pp.100542 |
| 著者・共著者 | Keisuke Shoji, Kenji Yanishi, Hirokazu Shiraishi, Shiho Yamabata, Arito Yukawa, Satoshi Teramukai, Kojiro Imai, Toshiko Ito-Ihara, Masami Tao, Yukihito Higashi, Tomoaki Ishigami, Yoshihiro Fukumoto, Koichiro Kuwahara, Satoaki Matoba |
| 発行年月 | 2020/03 |
| 概要 | UNLABELLED:Critical limb ischemia (CLI) is a potentially life-threatening condition that involves severely reduced blood flow to the peripheral arteries due to arteriosclerosis obliterans (ASO) of the limbs or a similar condition. CLI patients must undergo revascularization to avoid amputation of the lower limbs and improve their survival prognosis. However, the outcomes of conventional surgical revascularization or endovascular therapy are inadequate; therefore, establishing further effective treatment methods is an urgent task. We perform therapeutic angiogenesis using autologous bone marrow-derived mononuclear cells in clinical practice and demonstrated its safety and efficacy for CLI patients for whom conventional treatments failed or are not indicated. Exercise therapies must be devised for CLI patients who have undergone therapeutic angiogenesis to save their limbs and improve survival. Because evidence regarding the efficacy and safety of exercise therapy for CLI patients is lacking, we plan to perform a prospective trial of the efficacy and safety of optimal exercise therapy following therapeutic angiogenesis for CLI patients.The trial will enroll 30 patients between 20 and 79 years with Rutherford category 4 or 5 CLI caused by ASO who will undergo therapeutic angiogenesis. Participants will be randomly allocated to receive either optimal exercise therapy or fixed exercise therapy. Those receiving optimal exercise therapy will undergo tissue muscle oxygen saturation monitoring using near-infrared spectroscopy while performing exercises and will be prescribed optimal exercise therapy. The optimal amount of exercise will be determined on day 8, 31, 61, 91 and 181 after therapeutic angiogenesis.ETHICS AND DISSEMINATION:This protocol was approved by the Institutional Review Boards of Kyoto Prefectural University of Medicine. In accordance with the Helsinki Declaration, written informed consent has been obtained from all participants prior to enrollment. The resu |
| DOI | 10.1016/j.conctc.2020.100542 |
| PMID | 32072074 |