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

National University Health System (NUHS)

Status: Enrolling

Conditions: Healthy; Haematological Cancer

Treatments: Device: PEMF (1mT); Device: PEMF (0mT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06744764

2022/00928

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 25 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 4 patient groups

Haematology Patients

Experimental group

Description:

Patients will receive 1mT magnetic therapy twice per week for 4 consecutive weeks.

Treatment:

Device: PEMF (1mT)

Haematology Patients (Case-matched)

No Intervention group

Description:

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 group

Description:

Healthy volunteers will receive 1mT magnetic therapy twice per week for 4 consecutive weeks.

Treatment:

Device: PEMF (1mT)

Healthy volunteers (Sham)

Sham Comparator group

Description:

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.

Treatment:

Device: PEMF (0mT)