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

Not Applicable

Recruiting

• Conditions: Haematological Cancer; Healthy

• Registration Number: NCT06744764
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-17
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in physical deconditioning in haematology patients after 8 sessions of PEMF	Change in SPPB test result 4 and 8 weeks from baseline	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.
Changes in the levels of anti-cancer factors in blood plasma from haematology patients and healthy volunteers	Change in anti-cancer biomarkers levels in blood plasma from PEMF-exposed patients at week 4 and week 8 versus their own baseline.	Anti-cancer factors such as HTRA1 and Klotho can be altered with PEMF therapy in humans.

Trial Locations

Locations (2)

NUHS Investigational Medicine Unit; 🇸🇬 Kent Ridge, Singapore

National University Hospital; 🇸🇬 Kent Ridge, Singapore