NCT02293239

Brief Summary

This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function and quality of life of patients with malignant disease undergoing curative or palliative anti-cancer treatment

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

5 years

First QC Date

November 13, 2014

Last Update Submit

October 15, 2018

Conditions

CancerCancer CachexiaWeight LossMuscle LossMuscle Weakness

Keywords

whole-body electromyostimulationcachexiacancerskeletal muscle massnutrition

Outcome Measures

Primary Outcomes (2)

  • Skeletal muscle mass

    Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)

    12 weeks

  • Physical function - Gait pattern

    Sensor-based gait analysis

    12 weeks

Secondary Outcomes (7)

  • Physical function - Isometric muscle strength

    12 weeks

  • Physical function - Endurance

    12 weeks

  • Physical function - Lower limb strength

    12 weeks

  • Patient-reported performance status

    12 weeks

  • Patient-reported Quality of Life (QoL)

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

"usual care" control group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight)

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 \> 1.0 g/kg bodyweight)

Other: Whole-Body Electromyostimulation (WB-EMS)

Interventions

Whole-Body Electromyostimulation (WB-EMS)OTHER

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

WB-EMS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma,lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation
  • ongoing or planned curative or palliative anti-cancer therapy

You may not qualify if:

  • simultaneous participation in other nutritional or exercise intervention trials
  • acute cardiovascular events
  • use of anabolic medications
  • epilepsy
  • severe neurological diseases
  • skin lesions in the area of electrodes
  • energy active metals in body
  • pregnancy
  • acute vein thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Klinik 1, University of Erlangen-Nürnberg

Erlangen, Bavaria / Franconia, 91054, Germany

Location

Related Publications (2)

  • Schink K, Reljic D, Herrmann HJ, Meyer J, Mackensen A, Neurath MF, Zopf Y. Whole-Body Electromyostimulation Combined With Individualized Nutritional Support Improves Body Composition in Patients With Hematological Malignancies - A Pilot Study. Front Physiol. 2018 Dec 18;9:1808. doi: 10.3389/fphys.2018.01808. eCollection 2018.

    PMID: 30618820DERIVED

  • Schink K, Herrmann HJ, Schwappacher R, Meyer J, Orlemann T, Waldmann E, Wullich B, Kahlmeyer A, Fietkau R, Lubgan D, Beckmann MW, Hack C, Kemmler W, Siebler J, Neurath MF, Zopf Y. Effects of whole-body electromyostimulation combined with individualized nutritional support on body composition in patients with advanced cancer: a controlled pilot trial. BMC Cancer. 2018 Sep 12;18(1):886. doi: 10.1186/s12885-018-4790-y.

    PMID: 30208857DERIVED

MeSH Terms

Conditions

NeoplasmsWeight LossMuscular AtrophyMuscle WeaknessCachexia

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalMuscular DiseasesMusculoskeletal DiseasesPathologic ProcessesThinness

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 18, 2014

Study Start

August 1, 2013

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

October 16, 2018

Record last verified: 2018-10

Locations

DE(1)