AzTrials
AzTrials

Electric Stimulation TherapyNCT03467087

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

A study testing Myopuls 2000D in people with Electric Stimulation Therapy, run by University Hospital, Saarland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Electric Stimulation Therapy
What is being tested?
Myopuls 2000D
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
3 Feb 2016to 16 Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • history of ventricular arrhythmias
  • peripheral arterial disease
  • deep vein thrombosis in the past 3 month
  • myocardial infarction or stroke in the past 3 month

About this study

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).

Read more

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.

Being tested
Myopuls 2000D
Keywords
Stem cell transplantation, Chemotherapy, Rehabilitation, Electrical muscle stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Myopuls 2000DDevice

    Device: Myopuls 2000D (Curatec Services GmBH, 47443 Moers, Germany)

Study groups in NCT03467087
Study groupRoleWhat they receive
Electrical muscle stimulationExperimentalElectrical 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.
Receives: Device: Myopuls 2000D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurence of adverse events caused by EMS

    Possible adverse events: bleeding events (defined according to the WHO Bleeding Scale ), arrhythmias, CK elevation, skin irritation

    Measured: through study completion, an average of 30 days

  2. Feasibility of self administered EMS

    Percentage of patients able to complete at least 2/3 of the pre-set training time

    Measured: At the time of discharge of every patients, after an average of 30 days

Secondary outcomes (4)

  1. Physical performance as assessed by the 6 minute walking distance

    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.

    Measured: At the time of discharge of every patients, after an average of 30 days

  2. Physical performance as assessed by the Short Physical Performance Battery

    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

    Measured: At the time of discharge of every patients, after an average of 30 days

  3. Psychological performance as assessed by the Multidimensional Fatigue Inventory

    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.

    Measured: At the time of discharge of every patients, after an average of 30 days

  4. Psychological performance as assessed by the EORTC QoL 30 questionnaire

    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.

    Measured: At the time of discharge of every patients, after an average of 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2018
  2. Study start3 Feb 2016
  3. Primary completion16 Feb 2017
  4. Study completion16 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03467087
Sponsor's protocol ID
EMS-ICT-001
Status last verified
Mar 2018
First submitted
27 Feb 2018
Last updated
15 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • Wiskemann J, Kleindienst N, Kuehl R, Dreger P, Schwerdtfeger R, Bohus M. Effects of physical exercise on survival after allogeneic stem cell transplantation. Int J Cancer. 2015 Dec 1;137(11):2749-56. doi: 10.1002/ijc.29633. Epub 2015 Jun 19.

    PubMed 26061092

  • Wiskemann J, Huber G. Physical exercise as adjuvant therapy for patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Feb;41(4):321-9. doi: 10.1038/sj.bmt.1705917. Epub 2007 Nov 19.

    PubMed 18026154

  • Takekiyo T, Dozono K, Mitsuishi T, Murayama Y, Maeda A, Nakano N, Kubota A, Tokunaga M, Takeuchi S, Takatsuka Y, Utsunomiya A. Effect of exercise therapy on muscle mass and physical functioning in patients undergoing allogeneic hematopoietic stem cell transplantation. Support Care Cancer. 2015 Apr;23(4):985-92. doi: 10.1007/s00520-014-2425-7. Epub 2014 Sep 27.

    PubMed 25256376

  • Dobsak P, Novakova M, Fiser B, Siegelova J, Balcarkova P, Spinarova L, Vitovec J, Minami N, Nagasaka M, Kohzuki M, Yambe T, Imachi K, Nitta S, Eicher JC, Wolf JE. Electrical stimulation of skeletal muscles. An alternative to aerobic exercise training in patients with chronic heart failure? Int Heart J. 2006 May;47(3):441-53. doi: 10.1536/ihj.47.441.

    PubMed 16823250

  • Nuhr MJ, Pette D, Berger R, Quittan M, Crevenna R, Huelsman M, Wiesinger GF, Moser P, Fialka-Moser V, Pacher R. Beneficial effects of chronic low-frequency stimulation of thigh muscles in patients with advanced chronic heart failure. Eur Heart J. 2004 Jan;25(2):136-43. doi: 10.1016/j.ehj.2003.09.027.

    PubMed 14720530

  • Kern H, Barberi L, Lofler S, Sbardella S, Burggraf S, Fruhmann H, Carraro U, Mosole S, Sarabon N, Vogelauer M, Mayr W, Krenn M, Cvecka J, Romanello V, Pietrangelo L, Protasi F, Sandri M, Zampieri S, Musaro A. Electrical stimulation counteracts muscle decline in seniors. Front Aging Neurosci. 2014 Jul 24;6:189. doi: 10.3389/fnagi.2014.00189. eCollection 2014.

    PubMed 25104935

  • Windholz T, Swanson T, Vanderbyl BL, Jagoe RT. The feasibility and acceptability of neuromuscular electrical stimulation to improve exercise performance in patients with advanced cancer: a pilot study. BMC Palliat Care. 2014 May 1;13:23. doi: 10.1186/1472-684X-13-23. eCollection 2014.

    PubMed 24808760

  • Bewarder M, Klostermann A, Ahlgrimm M, Bittenbring JT, Pfreundschuh M, Wagenpfeil S, Kaddu-Mulindwa D. Safety and feasibility of electrical muscle stimulation in patients undergoing autologous and allogeneic stem cell transplantation or intensive chemotherapy. Support Care Cancer. 2019 Mar;27(3):1013-1020. doi: 10.1007/s00520-018-4390-z. Epub 2018 Aug 9.

    PubMed 30094730

Questions about this trial

What is this clinical trial studying?

A study testing Myopuls 2000D in people with Electric Stimulation Therapy, run by University Hospital, Saarland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurence of adverse events caused by EMS (time frame: through study completion, an average of 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03467087, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in