Electric Stimulation Therapy Clinical Trial
Official title:
Safety and Feasibility of Electrical Muscle Stimulation in Patients Undergoing Autologous and Allogeneic Stem Cell Transplantation or Chemotherapy Requiring Hospitalization
Intensive chemotherapy, with or without following autologous or allogeneic stem cell
transplantation (HSCT), is often the only curative treatment option for patients with
haematological malignancies, leave many survivors physically and psychologically impaired
because of side effects, many caused by weeks of immobilisation. Electrical muscle
stimulation (EMS) is a proven training tool to improve physical performance in seniors and
patients with chronic disease. The investigators therefore intend to evaluate the safety and
feasibility of EMS in patients undergoing autologous HSCT, allogeneic HSCT and intensive
chemotherapy. To assess feasibility all patients are asked to document training time during
hospitalization in an EMS diary.
Furthermore, physical Performance will be measured using the 6-minute-walking distance (6MWD)
and Short Physical Performance Battery (SPPB) as well as psychological performance using the
Multidimensional Fatigue Inventory (MFI) and EORTC QLQ-C30 at the start of chemotherapy (T1)
and when patients are discharged from hospital (T2).
At the time intensive chemotherapy is started and all inclusion and no exclusion criteria are
met, patients will receive an EMS device with electrodes and will be instructed on how to use
the device. After that, baseline tests using the above mentioned tools will be performed.
EMS will be conducted with a "Myopuls 2000" (Curatec Services GmbH, Moers, Germany) device
using 13 cm x 5 cm electrodes. Electrodes are placed subsequently on both thighs and upper
arms with instructions to stimulate each limb for at least 15 minutes on at least 5 days per
week. Stimulation settings were as follows: 300 µs pulse width, 60 Hz frequency, 5 seconds
on, 5 seconds off. The amplitude is initially set to elicit a visible muscle contraction and
patients are encouraged to increase the amplitude as much as tolerated. After an initial
training session, patients are to use the devices on their own and document their activities
in an EMS diary.
Patients are then asked to use EMS throughout their therapy in addition to physical therapy
until the day of their discharge when the initially performed tests are repeated.
The investigators hypothesis is, that EMS can be safely applied in patients undergoing
intensive chemotherapy regimens and that patients are able to administer EMS by themselfs.
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