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

Study Overview
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Brief Summary
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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.

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

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Other: WB-EMS
* Other: Nutritional support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 - Endurance | Six-minute-walk test (walking distance in m) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle weakness, muscle mass, whole-body electromyostimulation, WB-EMS, nutrition, protein, crohn's disease, ulcerative colitis