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

Primary Purpose

Inflammatory Bowel Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
WB-EMS
Nutritional support
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Bowel Diseases focused on measuring muscle weakness, muscle mass, whole-body electromyostimulation, WB-EMS, nutrition, protein, crohn's disease, ulcerative colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Universitätsklinikum Erlangen, Medizinische Klinik 1Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Nutrition

EMS+Nutrition

Arm Description

usual care treatment

high-protein nutrition therapy

WB-EMS Training (2x/week á 20 min) + high-protein nutrition therapy

Outcomes

Primary Outcome Measures

Skeletal muscle mass
assessed by bioelectrical impedance analysis in kg

Secondary Outcome Measures

Body composition
assessed by bioelectrical impedance analysis in kg or %
Physical function - isometric muscle strength
isometric hand grip strength assessed by hand dynamometer
Physical function - Endurance
Six-minute-walk test (walking distance in m)
Physical function - lower limb strength
isometric lower limb strength assessed by isometric force plates in N
Quality of Life
IBDQ-D
Physical activity
IPAQ
Disease activity (Crohn's disease)
Harvey Bradshaw Index
Disease activity (ulcerative colitis)
Mayo Score
Inflammation status
C-reactive protein (CRP)

Full Information

First Posted
May 15, 2018
Last Updated
May 28, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03540784
Brief Title
Effects of WB-EMS and High Protein Diet in IBD Patients
Official Title
Effect of Whole-body Electromyostimulation Combined With a High Protein Diet in Malnourished Patients With Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
muscle weakness, muscle mass, whole-body electromyostimulation, WB-EMS, nutrition, protein, crohn's disease, ulcerative colitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
usual care treatment
Arm Title
Nutrition
Arm Type
Experimental
Arm Description
high-protein nutrition therapy
Arm Title
EMS+Nutrition
Arm Type
Experimental
Arm Description
WB-EMS Training (2x/week á 20 min) + high-protein nutrition therapy
Intervention Type
Other
Intervention Name(s)
WB-EMS
Intervention 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
Intervention Type
Other
Intervention Name(s)
Nutritional support
Intervention Description
dietary monitoring by dietary records; nutritional counselling by dietician, dietary advices: 1.5 g/kg bodyweight/day
Primary Outcome Measure Information:
Title
Skeletal muscle mass
Description
assessed by bioelectrical impedance analysis in kg
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
assessed by bioelectrical impedance analysis in kg or %
Time Frame
12 weeks
Title
Physical function - isometric muscle strength
Description
isometric hand grip strength assessed by hand dynamometer
Time Frame
12 weeks
Title
Physical function - Endurance
Description
Six-minute-walk test (walking distance in m)
Time Frame
12 weeks
Title
Physical function - lower limb strength
Description
isometric lower limb strength assessed by isometric force plates in N
Time Frame
12 weeks
Title
Quality of Life
Description
IBDQ-D
Time Frame
12 weeks
Title
Physical activity
Description
IPAQ
Time Frame
12 weeks
Title
Disease activity (Crohn's disease)
Description
Harvey Bradshaw Index
Time Frame
12 weeks
Title
Disease activity (ulcerative colitis)
Description
Mayo Score
Time Frame
12 weeks
Title
Inflammation status
Description
C-reactive protein (CRP)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: outpatients with inflammatory bowel disease (Crohn's disease, ulcerative Colitis) adults (18 years and older) Exclusion Criteria: 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
Facility Information:
Facility Name
Universitätsklinikum Erlangen, Medizinische Klinik 1
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurdagül Zopf, Prof. Dr. med.
Phone
+49 9131 85-45218
Email
yurdaguel.zopf@k-erlangen.de
First Name & Middle Initial & Last Name & Degree
Hans Joachim Herrmann, Dr. oec. troph.
Phone
+49 9131 85-45017
Email
hans.herrmann@uk-erlangen.de

12. IPD Sharing Statement

Plan to Share IPD
No

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

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