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

January 6, 2025 updated by: National University Hospital, Singapore

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Singapore
      • Kent Ridge, Singapore, 119074
        • Recruiting
        • National University Hospital
        • Contact:
        • Principal Investigator:
          • Melissa Gaik Ming Ooi, MB BCh, BAO, MRCP(I), FRCPath,
      • Kent Ridge, Singapore, 117599
        • Completed
        • NUHS Investigational Medicine Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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