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Inflammatory Bowel DiseasesNCT03540784

Effects of WB-EMS and High Protein Diet in IBD Patients

A study testing WB-EMS and Nutritional support in people with Inflammatory Bowel Diseases, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with inflammatory bowel disease (IBD) often suffer from muscle weakness and a low bone mineral density as a consequence of systemic Inflammation and disease treatment limiting Quality of life in a considerable way. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inflammatory Bowel Diseases
What is being tested?
WB-EMS and Nutritional support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteGermany
Study dates
1 Oct 2013to 30 Sep 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

  • outpatients with inflammatory bowel disease (Crohn's disease, ulcerative Colitis)
  • adults (18 years and older)

Who cannot join

  • 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
Show all 9Show fewer
  • energy active metals in body
  • pregnancy
  • acute vein thrombosis

Trial locations and contacts

1 site in 1 country.

Germany1 site, 1 recruiting

  • Universitätsklinikum Erlangen, Medizinische Klinik 1

    Erlangen, Bavaria, 91054

    Yurdagül Zopf, Prof. Dr. med., +49 9131 85-45218, yurdaguel.zopf@k-erlangen.de

    Hans Joachim Herrmann, Dr. oec. troph., +49 9131 85-45017, hans.herrmann@uk-erlangen.de

    Recruiting

Other trials in Germany

About this study

Official title: Effect of Whole-body Electromyostimulation Combined With a High Protein Diet in Malnourished Patients With Inflammatory Bowel Disease

Patients with inflammatory bowel disease (IBD) often suffer from muscle weakness and a low bone mineral density as a consequence of systemic Inflammation and disease treatment limiting Quality of life in a considerable way. Exercise interventions to build up muscle mass and increasing physical function are promising Tools to improve the whole muscular Status of those patients. However, in the acute Phase of IBDs conventional Training methods may be too strenous, also because patients are suffering from acute gastrointestinal symptoms and feel fatigued. Due to those symptoms, patients present low Food intake and great loss of nutrients and energy especially by diarrhea. Individualized nutritional Support may be helpful to avoid malnutrition. The aim of this pilot study is to investigate the effect of a combined exercise and Nutrition Intervention using the gentle Training method of whole-body electromyostimulation (WB-EMS) combined with a individual high Protein nutritional Support on muscle mass, Body composition, physical function, Quality of life and gastrointestinal symptoms in outpatients with IBD.

Being tested
WB-EMS, Nutritional support
Keywords
muscle weakness, muscle mass, whole-body electromyostimulation, WB-EMS, nutrition, protein, crohn's disease, ulcerative colitis
Medical subject headings
Inflammatory Bowel Diseases, Muscle Weakness, Crohn Disease, Colitis, Ulcerative

What participants receive

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

  • WB-EMSOther

    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

  • Nutritional supportOther

    dietary monitoring by dietary records; nutritional counselling by dietician, dietary advices: 1.5 g/kg bodyweight/day

Study groups in NCT03540784
Study groupRoleWhat they receive
Control groupNo interventionusual care treatment
NutritionExperimentalhigh-protein nutrition therapy
Receives: Other: Nutritional support
EMS+NutritionExperimentalWB-EMS Training (2x/week á 20 min) + high-protein nutrition therapy
Receives: Other: WB-EMS; Other: Nutritional support

What is being measured

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

  1. Skeletal muscle mass

    assessed by bioelectrical impedance analysis in kg

    Measured: 12 weeks

Secondary outcomes (9)

  1. Body composition

    assessed by bioelectrical impedance analysis in kg or %

    Measured: 12 weeks

  2. Physical function - isometric muscle strength

    isometric hand grip strength assessed by hand dynamometer

    Measured: 12 weeks

  3. Physical function - Endurance

    Six-minute-walk test (walking distance in m)

    Measured: 12 weeks

  4. Physical function - lower limb strength

    isometric lower limb strength assessed by isometric force plates in N

    Measured: 12 weeks

  5. Quality of Life

    IBDQ-D

    Measured: 12 weeks

  6. Physical activity

    IPAQ

    Measured: 12 weeks

  7. Disease activity (Crohn's disease)

    Harvey Bradshaw Index

    Measured: 12 weeks

  8. Disease activity (ulcerative colitis)

    Mayo Score

    Measured: 12 weeks

  9. Inflammation status

    C-reactive protein (CRP)

    Measured: 12 weeks

Timeline

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

  1. First posted30 May 2018
  2. Study start1 Oct 2013
  3. Primary completion30 Sep 2019 (estimated)
  4. Study completion30 Sep 2019 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03540784
Sponsor's protocol ID
CED EMS
Status last verified
May 2018
First submitted
15 May 2018
Last updated
30 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing WB-EMS and Nutritional support in people with Inflammatory Bowel Diseases, 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 9 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 30 May 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?

On the ClinicalTrials.gov record for NCT03540784.

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 30 May 2018.

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