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

March 14, 2018 updated by: University Hospital, Saarland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 - 80 years of age
  • ECOG mperformance status 0-2
  • patients undergoing chemotherapy regimens and and expected hospitalization time of > 14 days

Exclusion Criteria:

  • patients with pacemakers and defibrillators
  • patients with metallic implants close to stimulation sites
  • skin irritations and injuries at the site of electrode placement
  • pregnancy
  • epilepsy
  • patient is physically or mentally unable to administer EMS by him/her -self
  • history of ventricular arrhythmias
  • peripheral arterial disease
  • deep vein thrombosis in the past 3 month
  • myocardial infarction or stroke in the past 3 month

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrical muscle stimulation
Electrical muscle stimulation is administered on both thighs and upper arms using a Myopuls 2000D device. Pre-set training time is 30 minutes per day (15 minutes for thighs and 15 minutes for upper arms) for at least 5 days a week.
Device: Myopuls 2000D
Device: Myopuls 2000D (Curatec Services GmBH, 47443 Moers, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of adverse events caused by EMS
Time Frame: through study completion, an average of 30 days
Possible adverse events: bleeding events (defined according to the WHO Bleeding Scale ), arrhythmias, CK elevation, skin irritation
through study completion, an average of 30 days
Feasibility of self administered EMS
Time Frame: At the time of discharge of every patients, after an average of 30 days
Percentage of patients able to complete at least 2/3 of the pre-set training time
At the time of discharge of every patients, after an average of 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical performance as assessed by the 6 minute walking distance
Time Frame: At the time of discharge of every patients, after an average of 30 days
Patients were told to walk on a 40-meter floor with instructions to cover as much distance as possible in 6 minutes. Patients were allowed to stop and rest as often as necessary. Time was stopped by a technician who was also allowed to encourage participants with standardized phrases during the walk.
At the time of discharge of every patients, after an average of 30 days
Physical performance as assessed by the Short Physical Performance Battery
Time Frame: At the time of discharge of every patients, after an average of 30 days

The Short Physical Performance Battery as developed by Guralnik and colleagues ranges from 0 - 12 points with 0 points indicating the worst possible performance and 12 points as best result. The battery consists of 3 objective tests of lower body function with maximally 4 points to be reached in one test:

  1. A timed walk of 8 feet
  2. The time it takes to rise from a chair 5 times
  3. A standing balance test
At the time of discharge of every patients, after an average of 30 days
Psychological performance as assessed by the Multidimensional Fatigue Inventory
Time Frame: At the time of discharge of every patients, after an average of 30 days
The Multidimensional Fatigue Inventory (MFI-20) consists of 5 subscales including general, physical and mental fatigue, reduced motivation and reduced activity with 20 items in total (4 items per subscale). Each item is rated on a 5-point scale (1-5) and each subscale ranges from 4 to 20. Patients were asked to fill out the test form before or within 3 days from start of treatment (timepoint 1) and at the day of discharge (timepoint 2). Contrary to physical assessment, high scores in the MFI subscales mean greater fatigue and therefore worse psychological functioning.
At the time of discharge of every patients, after an average of 30 days
Psychological performance as assessed by the EORTC QoL 30 questionnaire
Time Frame: At the time of discharge of every patients, after an average of 30 days
The EORTC QOL-C30 questionnaire contains 30 items that are divided into five functional scales, three symptom scales, a global health status / Quality of Life (QoL) scale, and six single items. Functional scales assess physical function (ability to manage daily life), role function (at work and daily activities), emotional function (tension, anxiety, irritability and depression), social function (family life or social activities) and cognitive function (concentration and memory). Symptom scales ask for fatigue, nausea or pain and single items measure dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial impact. The global health status / QoL scale rates overall health and quality of life. Original data was processed according to the EORTC scoring manual into a 0- to 100-point scale. High scores in functional scales and QoL indicate adequate function and QoL. Patients with high scores on symptom scales and single items show more severe symptoms and impairments.
At the time of discharge of every patients, after an average of 30 days

Collaborators and Investigators

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

Sponsor

University Hospital, Saarland

Investigators

  • Principal Investigator: Moritz Bewarder, M.D., University Hospital, Saarland
  • Principal Investigator: Dominic Kaddu-Mulindwa, M.D., University Hospital, Saarland

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)

February 3, 2016

Primary Completion (Actual)

February 16, 2017

Study Completion (Actual)

March 16, 2017

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EMS-ICT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We do not plan to share individual participant data sets since we think there is no additional information to be gained from individual data sets in this very heterogenous group of patients

Drug and device information, study documents

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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