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Идёт набор NCT06744764

Pulsed Electromagnetic Fields in Preventing Physical Deconditioning in Patients Undergoing Prolonged Hospitalization

Без фазы С лечением Haematological Cancer Healthy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PEMF (1mT), PEMF (0mT).
Кому может быть актуально
Состояния в реестре: Haematological Cancer, Healthy. Базовые параметры: 25 лет — 99 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Сингапур
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pulsed Electromagnetic Fields in Preventing Physical Deconditioning in Patients Undergoing Prolonged Hospitalization: A Case Match Control Study

Обзор

The goal of this clinical trial is to examine if pulsed electromagnetic fields (PEMF) can prevent or decrease physical deconditioning associated with prolonged hospitalisation and immobility of haematology patients. The main question\[s\] it aims to answer \[is/are\]: * Does haematology patients undergoing prolonged hospitalisation have no or decreased physical deconditioning when exposed to PEMF? * What are the changes in muscle secretome at baseline and after exposure to PEMF? Researchers will compare haematology patients who receive PEMF against patients who did not receive the treatment to see if there is a change in physical deconditioning. Healthy volunteers will also be recruited and randomized to either exposure to PEMF or no exposure. Haematology patients will * Have their blood taken at baseline, 4 weeks from baseline and 8 weeks from baseline. * Undergo SPPB test at baseline, 4 weeks and 8 weeks from baseline, and the test comprises of the time up and go test, 4 minute walk test and sit to stand test. * Either expose to PEMF twice per week for 4 consecutive weeks or no exposure. Healthy volunteers will * Have their blood taken at baseline, 4 weeks from baseline and 8 weeks from baseline. * Either expose to PEMF twice per week for 4 consecutive weeks or no exposure.

Вмешательства

  • Устройство PEMF (1mT)
    1mT of field strength will be given to patients/healthy volunteers for 10 minutes, twice per week for 4 consecutive weeks.
  • Устройство PEMF (0mT)
    Healthy volunteers will place their legs in the PEMF device, twice per week for 4 consecutive weeks. However, no magnetic stimulation will be given.

Первичные конечные точки

  • Change in physical deconditioning in haematology patients after 8 sessions of PEMF [Срок оценки: Change in SPPB test result 4 and 8 weeks from baseline]
  • Changes in the levels of anti-cancer factors in blood plasma from haematology patients and healthy volunteers [Срок оценки: Change in anti-cancer biomarkers levels in blood plasma from PEMF-exposed patients at week 4 and week 8 versus their own baseline.]

Критерии участия

Критерии включения

  • Haematology patients who are undergoing induction chemotherapy for acute leukemia
  • Haematology patients who are undergoing haematopoietic stem cell transplant
  • Have ECOG 0-24. Able to walk at baseline to participate in short physical battery test.
  • For healthy volunteers, subjects have to be healthy without any major disease states, not on any drugs or requiring long term medical attention.

Критерии исключения

  • Patients who do not agree to sign the consent form.
  • Pregnant women will be excluded from the study for healthy volunteers

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Сингапур · 2 центра
  • NUHS Investigational Medicine Unit — Kent Ridge
  • National University Hospital — Kent Ridge

Публикации

  • Venugobal S, Tai YK, Goh J, Teh S, Wong C, Goh I, Maier AB, Kennedy BK, Franco-Obregon A. Brief, weekly magnetic muscle therapy improves mobility and lean body mass in older adults: a Southeast Asia community case study. Aging (Albany NY). 2023 Mar 19;15(6):1768-1790. doi: 10.18632/aging.204597. Epub 2023 Mar 19. PMID 36934330
  • Stephenson MC, Krishna L, Pannir Selvan RM, Tai YK, Kit Wong CJ, Yin JN, Toh SJ, Torta F, Triebl A, Frohlich J, Beyer C, Li JZ, Tan SS, Wong CK, Chinnasamy D, Pakkiri LS, Lee Drum C, Wenk MR, Totman JJ, Franco-Obregon A. Magnetic field therapy enhances muscle mitochondrial bioenergetics and attenuates systemic ceramide levels following ACL reconstruction: Southeast Asian randomized-controlled pilo PMID 36262374
  • Yap JLY, Tai YK, Frohlich J, Fong CHH, Yin JN, Foo ZL, Ramanan S, Beyer C, Toh SJ, Casarosa M, Bharathy N, Kala MP, Egli M, Taneja R, Lee CN, Franco-Obregon A. Ambient and supplemental magnetic fields promote myogenesis via a TRPC1-mitochondrial axis: evidence of a magnetic mitohormetic mechanism. FASEB J. 2019 Nov;33(11):12853-12872. doi: 10.1096/fj.201900057R. Epub 2019 Sep 13. PMID 31518158
  • Iversen JN, Tai YK, Yap JLY, Abdul Razar RBB, Sukumar VK, Wu KY, Ooi MG, Kukumberg M, Adam S, Rufaihah AJ, Franco-Obregon A. One Month of Brief Weekly Magnetic Field Therapy Enhances the Anticancer Potential of Female Human Sera: Randomized Double-Blind Pilot Study. Cells. 2025 Feb 23;14(5):331. doi: 10.3390/cells14050331. PMID 40072060

Идентификаторы

NCT: NCT06744764 · 2022/00928

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗