NCT03540784

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

6 years

First QC Date

May 15, 2018

Last Update Submit

May 28, 2018

Conditions

Inflammatory Bowel Diseases

Keywords

muscle weaknessmuscle masswhole-body electromyostimulationWB-EMSnutritionproteincrohn's diseaseulcerative colitis

Outcome Measures

Primary Outcomes (1)

  • Skeletal muscle mass

    assessed by bioelectrical impedance analysis in kg

    12 weeks

Secondary Outcomes (9)

  • Body composition

    12 weeks

  • Physical function - isometric muscle strength

    12 weeks

  • Physical function - Endurance

    12 weeks

  • Physical function - lower limb strength

    12 weeks

  • Quality of Life

    12 weeks

  • +4 more secondary outcomes

Study Arms (3)

Control group

NO INTERVENTION

usual care treatment

Nutrition

EXPERIMENTAL

high-protein nutrition therapy

Other: Nutritional support

EMS+Nutrition

EXPERIMENTAL

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

Other: WB-EMSOther: Nutritional support

Interventions

WB-EMSOTHER

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

EMS+Nutrition
Nutritional supportOTHER

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

EMS+NutritionNutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • outpatients with inflammatory bowel disease (Crohn's disease, ulcerative Colitis)
  • adults (18 years and older)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Erlangen, Medizinische Klinik 1

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel DiseasesMuscle WeaknessCrohn DiseaseColitis, Ulcerative

Interventions

Nutritional Support

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsColitisColonic Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 30, 2018

Study Start

October 1, 2013

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

May 30, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)