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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]:
Haematology patients will
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haematology Patients | Experimental | Patients will receive 1mT magnetic therapy twice per week for 4 consecutive weeks. |
|
| Haematology Patients (Case-matched) | No Intervention | Case-matched haematology patients will be recruited after 20 haematology patients receiving the intervention has been recruited. The parameters for matching would be chemotherapy vs bone marrow transplant, age and fitness level according to the short physical performance battery (SPPB) score (0-2, 3-9, 10-12). | |
| Healthy Volunteers (PEMF) | Experimental | Healthy volunteers will receive 1mT magnetic therapy twice per week for 4 consecutive weeks. |
|
| Healthy volunteers (Sham) | Sham Comparator | Healthy volunteers will place their legs in the PEMF device, same as the volunteers receiving the therapy, twice per week for 4 consecutive weeks. However, no magnetic stimulation will be given to this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEMF (1mT) | Device | 1mT of field strength will be given to patients/healthy volunteers for 10 minutes, twice per week for 4 consecutive weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical deconditioning in haematology patients after 8 sessions of PEMF | The haematology patients will undergo the SPPB test which comprises of the time up and go (TUG) test, 4 minute walk test and 5 times sit to stand (STS) test. The same test will be repeated 4 and 8 weeks from baseline. Based on the case study report done previously, we anticipate an improvement of TUG mean by 1.9sec, 5-times STS by 2.3sec and 4 min walk test by 0.14meters by the end of the 8 week therapy. We will consider the trend to be significant if 2 out of 3 three parameters in the SPPB are met. | 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 | Anti-cancer factors such as HTRA1 and Klotho can be altered with PEMF therapy in humans. | Change in anti-cancer biomarkers levels in blood plasma from PEMF-exposed patients at week 4 and week 8 versus their own baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Ooi, MB BCh, BAO, MRCP(I), FRCPath, | Contact | 6772 2526 | melissa_ooi@nuhs.edu.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NUHS Investigational Medicine Unit | Completed | Kent Ridge | 117599 | Singapore | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36934330 | Background | 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. | |
| 36262374 | Background |
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Age, ethnicity, medical history, diet, physical activity, anthropometrics
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Apr 11, 2024 | Dec 16, 2024 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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Clinical trial coordinators
| PEMF (0mT) | Device | Healthy volunteers will place their legs in the PEMF device, twice per week for 4 consecutive weeks. However, no magnetic stimulation will be given. |
|
| National University Hospital |
| Recruiting |
| Kent Ridge |
| 119074 |
| Singapore |
|
| 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 pilot trial. J Orthop Translat. 2022 Oct 13;35:99-112. doi: 10.1016/j.jot.2022.09.011. eCollection 2022 Jul. |
| 31518158 | Background | 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. |
| 40072060 | Derived | 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. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |