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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03540784
Enrollment
75
Registered
2018-05-30
Start date
2013-10-01
Completion date
2019-09-30
Last updated
2018-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

Keywords

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

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.

Interventions

OTHERWB-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

OTHERNutritional support

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

Sponsors

University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Skeletal muscle mass12 weeksassessed by bioelectrical impedance analysis in kg

Secondary

MeasureTime frameDescription
Physical activity12 weeksIPAQ
Body composition12 weeksassessed by bioelectrical impedance analysis in kg or %
Physical function - isometric muscle strength12 weeksisometric hand grip strength assessed by hand dynamometer
Physical function - Endurance12 weeksSix-minute-walk test (walking distance in m)
Quality of Life12 weeksIBDQ-D
Disease activity (Crohn's disease)12 weeksHarvey Bradshaw Index
Disease activity (ulcerative colitis)12 weeksMayo Score
Inflammation status12 weeksC-reactive protein (CRP)
Physical function - lower limb strength12 weeksisometric lower limb strength assessed by isometric force plates in N

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026