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

• ClinicalTrials.gov Identifier: NCT03540784
• Recruitment Status: Unknown
• First Posted: May 30, 2018
• Last Update Posted: May 30, 2018
• Sponsor: University of Erlangen-Nürnberg Medical School
• Information provided by (Responsible Party): University of Erlangen-Nürnberg Medical School

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.

Condition or disease	Intervention/treatment	Phase
Inflammatory Bowel Diseases	Other: WB-EMS; Other: Nutritional support	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effect of Whole-body Electromyostimulation Combined With a High Protein Diet in Malnourished Patients With Inflammatory Bowel Disease
• Actual Study Start Date: October 1, 2013
• Estimated Primary Completion Date: September 30, 2019
• Estimated Study Completion Date: September 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Skeletal muscle mass [ Time Frame: 12 weeks ]
   assessed by bioelectrical impedance analysis in kg

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Germany

Universitätsklinikum Erlangen, Medizinische Klinik 1; Recruiting

Erlangen, Bavaria, Germany, 91054

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

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

Sponsors and Collaborators

University of Erlangen-Nürnberg Medical School

More Information

• Responsible Party: University of Erlangen-Nürnberg Medical School
• ClinicalTrials.gov Identifier: NCT03540784
• Other Study ID Numbers: CED EMS
• First Posted: May 30, 2018
• Last Update Posted: May 30, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Erlangen-Nürnberg Medical School:

muscle weakness; muscle mass; whole-body electromyostimulation; WB-EMS; nutrition; protein; crohn's disease; ulcerative colitis

Additional relevant MeSH terms:

Intestinal Diseases; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis