Ulcerative ColitisNCT02144129
Effects of WB-EMS in Ulcerative Colitis Patients
A study testing active Whole Body Electromyostimulation, Passive WB-EMS and WB-EMS application in people with Ulcerative Colitis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The purpose of this study is to determine the effect of 12 weeks of WB-EMS either applicated passive in a supine resting position or active during slight movements compared with a non-training control group on body composition, muscle strength and QoL in patients with ulcerative colitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- active Whole Body Electromyostimulation, Passive WB-EMS and WB-EMS application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Jan 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ulcerative colitis
- ambulatory subjects
Who cannot join
- variables that conflicts with WB-EMS application (e.g. cardiac pacemakers)
- absence of more than two weeks during the interventional period.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Klinik 1, University of Erlangen-Nurnberg
Erlangen, Franconia, 91054
About this study
Official title: Effects of Different Types of Whole Body Electromyostimulation (WB-EMS) Application on Body Composition, Muscle Strength and Quality of Life in Patients With Ulcerative Colitis
The purpose of this study is to determine the effect of 12 weeks of WB-EMS either applicated passive in a supine resting position or active during slight movements compared with a non-training control group on body composition, muscle strength and QoL in patients with ulcerative colitis.
Our main hypothesis is that active WB-EMS application is significantly more favorable to address our primary endpoints compared with passive application.
Our secondary hypothesis is that passive WB-EMS application is significantly more favorable to address our primary endpoints compared with non-training control.
- Conditions
- Ulcerative Colitis
- Being tested
- active Whole Body Electromyostimulation, Passive WB-EMS, WB-EMS application
- Keywords
- Whole Body Electromyostimulation, Inflammatory Bowel Disease, Lean Body Mass, Muscle Strength
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active Whole Body ElectromyostimulationOther
Passive WB-EMSOther
WB-EMS applicationDevice
| Study group | Role | What they receive |
|---|---|---|
| active WB-EMS | Experimental | 2 sessions/week with 20 min of active WB-EMS application Receives: Other: active Whole Body Electromyostimulation; Device: WB-EMS application |
| Passive WB-EMS | Experimental | 2 sessions/week with 20 min of passive WB-EMS application in a resting supine position Receives: Other: Passive WB-EMS |
| Inactive Control Group | No intervention | sedentary non-training control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean Body Mass
Lean Body Mass (LBM) and Appendicular Skeletal Muscle Mass (ASMM) as assessed by Dual-Energy-x-Ray Absorptiometry (DXA)
Measured: 12 weeks, baseline to 12 week follow-up
Isokinetic muscle strength
Isokinetic muscle strength of the leg extensors and - flexors as assessed by a isokinetic leg strength
Measured: 12 weeks, baseline to 12 week follow-up
Secondary outcomes (2)
Quality of Life (QoL)
QoL as assessed by inflammatory bowel disease questionnaire (IBDQ-D) and Depression Scores
Measured: 12 weeks, baseline to 12 week follow-up
Isometric muscle strength
Isometric strength of the trunk flexors.
Measured: 12 weeks, baseline 12 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- University of Erlangen-Nürnberg
- Responsible party
- Principal investigator, Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
- Investigators
- Yurdagül Zopf, MD, Study chair, University of Erlangen-NürnbergWolfgang K Kemmler, PhD, Study director, University of Erlangen-Nürnberg Medical SchoolMichael Weineck, MS, Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144129
- Sponsor's protocol ID
- EMS_COL
- Other IDs
- Substudy 1
- Status last verified
- Jan 2018
- First submitted
- 19 May 2014
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Kemmler W, von Stengel S. Whole-body electromyostimulation as a means to impact muscle mass and abdominal body fat in lean, sedentary, older female adults: subanalysis of the TEST-III trial. Clin Interv Aging. 2013;8:1353-64. doi: 10.2147/CIA.S52337. Epub 2013 Oct 7.
PubMed 24130433Kemmler W, Bebenek M, Engelke K, von Stengel S. Impact of whole-body electromyostimulation on body composition in elderly women at risk for sarcopenia: the Training and ElectroStimulation Trial (TEST-III). Age (Dordr). 2014 Feb;36(1):395-406. doi: 10.1007/s11357-013-9575-2. Epub 2013 Aug 16.
PubMed 23949160
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Types of Whole Body Electromyostimulation (WB-EMS) Application on Body Composition, Muscle Strength and Quality of Life in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02144129
- Acronym / sponsor ID
- EMS_COL
- Conditions
- Ulcerative Colitis
- Keywords
- Whole Body Electromyostimulation, Inflammatory Bowel Disease, Lean Body Mass, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- University of Erlangen-Nürnberg
- Study start
- Mar 2014
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 21 May 2014 (estimated)
- 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.
The purpose of this study is to determine the effect of 12 weeks of WB-EMS either applicated passive in a supine resting position or active during slight movements compared with a non-training control group on body composition, muscle strength and QoL in patients with ulcerative colitis.
Our main hypothesis is that active WB-EMS application is significantly more favorable to address our primary endpoints compared with passive application.
Our secondary hypothesis is that passive WB-EMS application is significantly more favorable to address our primary endpoints compared with non-training control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active WB-EMS | Experimental | Other: active Whole Body Electromyostimulation, Device: WB-EMS application2 sessions/week with 20 min of active WB-EMS application |
| Passive WB-EMS | Experimental | Other: Passive WB-EMS2 sessions/week with 20 min of passive WB-EMS application in a resting supine position |
| Inactive Control Group | No intervention | –sedentary non-training control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ulcerative colitis
- ambulatory subjects
Key exclusion criteria (2 listed)
- variables that conflicts with WB-EMS application (e.g. cardiac pacemakers)
- absence of more than two weeks during the interventional period.
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 |
|---|---|---|
| active Whole Body Electromyostimulation | Other | active WB-EMS |
| Passive WB-EMS | Other | Passive WB-EMS |
| WB-EMS application | Device | active WB-EMS |
Primary outcome
Lean Body Mass
Time frame: 12 weeks, baseline to 12 week follow-up
Lean Body Mass (LBM) and Appendicular Skeletal Muscle Mass (ASMM) as assessed by Dual-Energy-x-Ray Absorptiometry (DXA)
Isokinetic muscle strength
Time frame: 12 weeks, baseline to 12 week follow-up
Isokinetic muscle strength of the leg extensors and - flexors as assessed by a isokinetic leg strength
2 secondary outcomes
Quality of Life (QoL)
Time frame: 12 weeks, baseline to 12 week follow-up
Isometric muscle strength
Time frame: 12 weeks, baseline 12 week follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Background: PubMed 24130433Kemmler W, von Stengel S. Whole-body electromyostimulation as a means to impact muscle mass and abdominal body fat in lean, sedentary, older female adults: subanalysis of the TEST-III trial. Clin Interv Aging. 2013;8:1353-64. doi: 10.2147/CIA.S52337. Epub 2013 Oct 7.
- Background: PubMed 23949160Kemmler W, Bebenek M, Engelke K, von Stengel S. Impact of whole-body electromyostimulation on body composition in elderly women at risk for sarcopenia: the Training and ElectroStimulation Trial (TEST-III). Age (Dordr). 2014 Feb;36(1):395-406. doi: 10.1007/s11357-013-9575-2. Epub 2013 Aug 16.
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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.
Yurdagül Zopf, MD study chair
University of Erlangen-Nürnberg
Wolfgang K Kemmler, PhD study director
University of Erlangen-Nürnberg Medical School
Michael Weineck, MS principal investigator
University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active Whole Body Electromyostimulation, Passive WB-EMS and WB-EMS application in people with Ulcerative Colitis, 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 25 Jan 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Lean Body Mass (time frame: 12 weeks, baseline to 12 week follow-up). 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 NCT02144129, which also lists 2 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 25 Jan 2018.