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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-17

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Haematological Cancer Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Clinical trial coordinators

Study Groups

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Haematology Patients

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

Group Type EXPERIMENTAL

PEMF (1mT)

Intervention Type DEVICE

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

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthy Volunteers (PEMF)

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

Group Type EXPERIMENTAL

PEMF (1mT)

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

PEMF (0mT)

Intervention Type 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.

Interventions

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PEMF (1mT)

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.