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

NCT ID: NCT03540784

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-01
• Study Completion Date: 2019-09-30

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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control group

usual care treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Nutrition

high-protein nutrition therapy

Group Type: EXPERIMENTAL

Nutritional support

Intervention Type: OTHER

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

EMS+Nutrition

WB-EMS Training (2x/week á 20 min) + high-protein nutrition therapy

Group Type: EXPERIMENTAL

WB-EMS

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Nutritional support

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinikum Erlangen, Medizinische Klinik 1

Erlangen, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Yurdagül Zopf, Prof. Dr. med.

Role: primary

yurdaguel.zopf@k-erlangen.de

+49 9131 85-45218

Hans Joachim Herrmann, Dr. oec. troph.

Role: backup

hans.herrmann@uk-erlangen.de

+49 9131 85-45017

Other Identifiers

CED EMS

Identifier Type: -

Identifier Source: org_study_id