Hematologic DiseasesNCT03556748
WB-EMS and Nutrition in Patients With Hematological Malignancies
A study testing whole-body electromyostimulation in people with Hematologic Diseases and Cachexia; Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This study evaluates the effects of a whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on skeletal muscle mass, body composition, muscle strength/function, quality of life, fatigue, pain and gastrointestinal symptoms in patients with hematological malignancies 4-6… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Diseases, Cachexia; Cancer, Leukemia
- What is being tested?
- whole-body electromyostimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 31 Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients diagnosed with hematological malignancies with an indication for stem cell Transplantation
- Interval until Transplantation: 6 weeks
- ECOG Status 0-2
Who cannot join
- patients with serious osteolytic lesions and increased risk of fall
- simultaneous participation in other nutritional or exercise intervention Trials or in the past 6 months
- acute cardiovascular events
- use of anabolic medications
- epilepsy
- severe neurological diseases
Show all 12Show fewer
- skin lesions in the area of electrodes
- energy active metals in body
- acute vein thrombosis
- rheumatic diseases
- pregnant and nursing women
- psychiatric disorders with doubts about legal and cognitive capacity
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, 91052
Yurdaguel Zopf, Prof. Dr. med., +49 9131 85-45218, yurdaguel.zopf@uk-erlangen.de
Hans Joachim Herrmann, Dr. oec. troph., +49 9131 85-45017, hans.herrmann@uk-erlangen.de
About this study
Official title: Effect of Whole-body Electromyostimulation Combined With Individualized Nutritional Support on Patients With Hematological Malignancies
This study evaluates the effects of a whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on skeletal muscle mass, body composition, muscle strength/function, quality of life, fatigue, pain and gastrointestinal symptoms in patients with hematological malignancies 4-6 weeks before and 4-6 weeks after undergoing stem cell Transplantation. Within this context, this study also investigates the effect of the nutrition and exercise intervention on the period of hospitalization, period of White blood cell recovery and frequency and severity of complications (mucositis, Graft-versus-Host-Disease, infections) after stem cell Transplantation as consequences of the therapeutic immune Suppression.
- Conditions
- Hematologic Diseases, Cachexia; Cancer, Leukemia, Myeloma, Lymphoma, Cancer
- Being tested
- whole-body electromyostimulation
- Keywords
- hematological malignancies, leukemia, myeloma, lymphoma, exercise, nutrition, protein, WB-EMS, whole-body electromyostimulation
- Medical subject headings
- Hematologic Diseases, Cachexia, Neoplasms, Leukemia, Neoplasms, Plasma Cell, Lymphoma, Hematologic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole-body electromyostimulationOther
WB-EMS training is performed 2x/week for a total of 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | usual care" control group receives individualized nutritional support (dietary advices: daily protein intake 1.2-1.5 g/kg bodyweight), active exercise therapy is optionally provided (bicycle ergometers at room) during the in-Patient stay |
| WB-EMS group | Experimental | physical exercise group regular WB-EMS training (2 EMS trainings per week; each session for 20 min)
+ individualized nutritional support (dietary advices: daily protein intake 1.2-1.5 g/kg bodyweight)
active exercise therapy is optionally provided (bicycle ergometers at room) during the in-Patient stay Receives: Other: whole-body electromyostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle mass
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Measured: 12 weeks
Secondary outcomes (6)
Physical function - Isometric muscle strength
Hand grip strength assessed by hand dynamometer (in kg)
Measured: 12 weeks
Cardiorespiratory Fitness
VO2max assessed by spirometry
Measured: 12 weeks
Patient-reported Quality of Life (QoL)
EORTC QLQ - C30 questionnaire
Measured: 12 weeks
Patient-reported Fatigue
FACIT-Fatigue scale
Measured: 12 weeks
Depression/Anxiety
Hospital Anxiety and Depression Scale
Measured: 12 weeks
Inflammatory blood markers
Blood collection and analysis (Albumin, CRP, Cytokines)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 Nov 2017
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- WB-EMS training is performed 2x/week for 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556748
- Sponsor's protocol ID
- EMS Nutr hemato onko
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 14 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole-body Electromyostimulation Combined With Individualized Nutritional Support on Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT03556748
- Acronym / sponsor ID
- EMS Nutr hemato onko
- Conditions
- Hematologic Diseases, Cachexia; Cancer, Leukemia, Myeloma, Lymphoma, Cancer
- Keywords
- hematological malignancies, leukemia, myeloma, lymphoma, exercise, nutrition, protein, WB-EMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effects of a whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on skeletal muscle mass, body composition, muscle strength/function, quality of life, fatigue, pain and gastrointestinal symptoms in patients with hematological malignancies 4-6 weeks before and 4-6 weeks after undergoing stem cell Transplantation. Within this context, this study also investigates the effect of the nutrition and exercise intervention on the period of hospitalization, period of White blood cell recovery and frequency and severity of complications (mucositis, Graft-versus-Host-Disease, infections) after stem cell Transplantation as consequences of the therapeutic immune Suppression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- WB-EMS training is performed 2x/week for 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –usual care" control group receives individualized nutritional support (dietary advices: daily protein intake 1.2-1.5 g/kg bodyweight), active exercise therapy is optionally provided (bicycle ergometers at room) during the in-Patient stay |
| WB-EMS group | Experimental | Other: whole-body electromyostimulationphysical exercise group regular WB-EMS training (2 EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake 1.2-1.5 g/kg bodyweight) active exercise therapy is optionally provided (bicycle ergometers at room) during the in-Patient stay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients diagnosed with hematological malignancies with an indication for stem cell Transplantation
- Interval until Transplantation: 6 weeks
- ECOG Status 0-2
Key exclusion criteria (12 listed)
- patients with serious osteolytic lesions and increased risk of fall
- simultaneous participation in other nutritional or exercise intervention Trials or in the past 6 months
- acute cardiovascular events
- use of anabolic medications
- epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole-body electromyostimulationWB-EMS training is performed 2x/week for a total of 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial | Other | WB-EMS group |
Primary outcome
Skeletal muscle mass
Time frame: 12 weeks
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
6 secondary outcomes
Physical function - Isometric muscle strength
Time frame: 12 weeks
Cardiorespiratory Fitness
Time frame: 12 weeks
Patient-reported Quality of Life (QoL)
Time frame: 12 weeks
Patient-reported Fatigue
Time frame: 12 weeks
Depression/Anxiety
Time frame: 12 weeks
Inflammatory blood markers
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole-body electromyostimulation in people with Hematologic Diseases and Cachexia; Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 12 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: status not confirmed, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle mass (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2018.