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

Not Applicable

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT03540784
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-01
• Status Verified: 2018-05
• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-28
• Last Update Submitted: 2018-05-28
• Study First Posted: 2018-05-30
• Last Update Posted: 2018-05-30
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Skeletal muscle mass	12 weeks	assessed by bioelectrical impedance analysis in kg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitätsklinikum Erlangen, Medizinische Klinik 1; 🇩🇪 Erlangen, Bavaria, Germany