NCT03467087

Safety and Feasibility of Electrical Muscle Stimulation During Stem Cell Transplantation or Intensive Chemotherapy

Completed NA Last updated 15 March 2018

What this trial tests

NA trial testing Myopuls 2000D in Electric Stimulation Therapy in 45 participants. Completed in 16 March 2017.

Timeline

3 February 2016

Primary endpoint
16 February 2017

16 March 2017

Quick facts

Lead sponsor	University Hospital, Saarland
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	45
Start date	3 February 2016
Primary completion	16 February 2017
Estimated completion	16 March 2017

Drugs / interventions tested

• Myopuls 2000D

Conditions studied

• Electric Stimulation Therapy — all drugs for Electric Stimulation Therapy →

Sponsor

University Hospital, Saarland

Who can join

Adults 18 to 80, any sex, with Electric Stimulation Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and feasibility of electrical muscle stimulation in patients undergoing autologous and allogeneic stem cell transplantation or intensive chemotherapy.
   Bewarder M, Klostermann A, Ahlgrimm M, Bittenbring JT, et al · · 2019 · cited 5× · PMID 30094730 · DOI 10.1007/s00520-018-4390-z