Pulsed Electromagnetic Fields in Preventing Physical Deconditioning in Patients Undergoing Prolonged Hospitalization (PEMF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Haematological Cancer
• Intervention / Treatment: Device: PEMF (0mT); Device: PEMF (1mT)

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Ooi, MB BCh, BAO, MRCP(I), FRCPath,; Phone Number: 6772 2526; Email: melissa_ooi@nuhs.edu.sg

Study Locations

• Singapore
  • Kent Ridge, Singapore, 119074
    • Recruiting
    • National University Hospital
    • Contact: Trisha Nur Nur Ili; Phone Number: +65 8660 6747; Email: trisha_IWANSUHAIMI@nuhs.edu.sg
    • Principal Investigator: Melissa Gaik Ming Ooi, MB BCh, BAO, MRCP(I), FRCPath,
  • Kent Ridge, Singapore, 117599
    • Completed
    • NUHS Investigational Medicine Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Haematology Patients (Case-matched); 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).
Sham Comparator: Healthy volunteers (Sham); 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.	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.
Experimental: Haematology Patients; Patients will receive 1mT magnetic therapy twice per week for 4 consecutive weeks.	Device: PEMF (1mT); 1mT of field strength will be given to patients/healthy volunteers for 10 minutes, twice per week for 4 consecutive weeks.
Experimental: Healthy Volunteers (PEMF); Healthy volunteers will receive 1mT magnetic therapy twice per week for 4 consecutive weeks.	Device: PEMF (1mT); 1mT of field strength will be given to patients/healthy volunteers for 10 minutes, twice per week for 4 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Muscle atrophy; Magnetic therapy; Cancer management
• Other Study ID Numbers: 2022/00928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Age, ethnicity, medical history, diet, physical activity, anthropometrics
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No