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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Other: Nutritional support; Other: WB-EMS

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Universitätsklinikum Erlangen, Medizinische Klinik 1
      • Contact: Yurdagül Zopf, Prof. Dr. med.; Phone Number: +49 9131 85-45218; Email: yurdaguel.zopf@k-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; usual care treatment
Experimental: Nutrition; high-protein nutrition therapy	Other: Nutritional support; dietary monitoring by dietary records; nutritional counselling by dietician, dietary advices: 1.5 g/kg bodyweight/day
Experimental: EMS+Nutrition; WB-EMS Training (2x/week á 20 min) + high-protein nutrition therapy	Other: Nutritional support; dietary monitoring by dietary records; nutritional counselling by dietician, dietary advices: 1.5 g/kg bodyweight/day; Other: WB-EMS; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle mass	assessed by bioelectrical impedance analysis in kg	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function - Endurance	Six-minute-walk test (walking distance in m)	12 weeks
Body composition	assessed by bioelectrical impedance analysis in kg or %	12 weeks
Physical function - isometric muscle strength	isometric hand grip strength assessed by hand dynamometer	12 weeks
Physical function - lower limb strength	isometric lower limb strength assessed by isometric force plates in N	12 weeks
Quality of Life	IBDQ-D	12 weeks
Physical activity	IPAQ	12 weeks
Disease activity (Crohn's disease)	Harvey Bradshaw Index	12 weeks
Disease activity (ulcerative colitis)	Mayo Score	12 weeks
Inflammation status	C-reactive protein (CRP)	12 weeks

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 28, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: muscle weakness; nutrition; muscle mass; ulcerative colitis; whole-body electromyostimulation; protein; crohn's disease; WB-EMS
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: CED EMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No