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

Official title

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

Overview

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.

Interventions

• Device PEMF (1mT)
  1mT of field strength will be given to patients/healthy volunteers for 10 minutes, twice per week for 4 consecutive weeks.
• Device 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.

Primary outcome measures

• Change in physical deconditioning in haematology patients after 8 sessions of PEMF [Time frame: 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 [Time frame: Change in anti-cancer biomarkers levels in blood plasma from PEMF-exposed patients at week 4 and week 8 versus their own baseline.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Singapore · 2 centers

• NUHS Investigational Medicine Unit — Kent Ridge
• National University Hospital — Kent Ridge

Publications

• 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

Identifiers

NCT: NCT06744764 · 2022/00928

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗