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NCT Number: NCT06744764

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

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.

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Key information

Conditions

Haematological Cancer Atrophy Healthy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NUHS Investigational Medicine Unit, Kent Ridge, Singapore

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEMF (1mT)

Device

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

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.

Primary outcomes

  1. 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

    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.

  2. 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.

    Anti-cancer factors such as HTRA1 and Klotho can be altered with PEMF therapy in humans.

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Ooi, MB BCh, BAO, MRCP(I), FRCPath,

CONTACT

[email protected]

6772 2526

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

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

Acronym: PEMF

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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