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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
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 lim...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7015992/ https://www.ncbi.nlm.nih.gov/pubmed/32072074 http://dx.doi.org/10.1016/j.conctc.2020.100542 |
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author | Shoji, Keisuke Yanishi, Kenji Shiraishi, Hirokazu Yamabata, Shiho Yukawa, Arito Teramukai, Satoshi Imai, Kojiro Ito-Ihara, Toshiko Tao, Masami Higashi, Yukihito Ishigami, Tomoaki Fukumoto, Yoshihiro Kuwahara, Koichiro Matoba, Satoaki |
author_facet | Shoji, Keisuke Yanishi, Kenji Shiraishi, Hirokazu Yamabata, Shiho Yukawa, Arito Teramukai, Satoshi Imai, Kojiro Ito-Ihara, Toshiko Tao, Masami Higashi, Yukihito Ishigami, Tomoaki Fukumoto, Yoshihiro Kuwahara, Koichiro Matoba, Satoaki |
author_sort | Shoji, Keisuke |
collection | PubMed |
description | 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 results of this trial will be disseminated by publication in a peer-reviewed journal. TRIAL REGISTRATION: This trial is registered at http://www.umin.ac.jp/ctr/index.htm (identifier: UMIN000035288). |
format | Online Article Text |
id | pubmed-7015992 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-70159922020-02-18 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 Shoji, Keisuke Yanishi, Kenji Shiraishi, Hirokazu Yamabata, Shiho Yukawa, Arito Teramukai, Satoshi Imai, Kojiro Ito-Ihara, Toshiko Tao, Masami Higashi, Yukihito Ishigami, Tomoaki Fukumoto, Yoshihiro Kuwahara, Koichiro Matoba, Satoaki Contemp Clin Trials Commun Article 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 results of this trial will be disseminated by publication in a peer-reviewed journal. TRIAL REGISTRATION: This trial is registered at http://www.umin.ac.jp/ctr/index.htm (identifier: UMIN000035288). Elsevier 2020-02-04 /pmc/articles/PMC7015992/ /pubmed/32072074 http://dx.doi.org/10.1016/j.conctc.2020.100542 Text en © 2020 The Authors. Published by Elsevier Inc. http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Shoji, Keisuke Yanishi, Kenji Shiraishi, Hirokazu Yamabata, Shiho Yukawa, Arito Teramukai, Satoshi Imai, Kojiro Ito-Ihara, Toshiko Tao, Masami Higashi, Yukihito Ishigami, Tomoaki Fukumoto, Yoshihiro Kuwahara, Koichiro Matoba, Satoaki 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7015992/ https://www.ncbi.nlm.nih.gov/pubmed/32072074 http://dx.doi.org/10.1016/j.conctc.2020.100542 |
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