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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03540784
• Other study ID #: CED EMS
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2013
• Est. completion date: September 30, 2019

Study information

• Verified date: May 2018
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Erlangen, Medizinische Klinik 1	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

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