PRE-BIOTIC: Progressive Resistance Exercise- BIOTa and Inflammation in Crohn’s & colitis

Not Applicable

Recruiting

• Conditions: Crohn's disease; Ulcerative colitis; Oral and Gastrointestinal - Crohn's disease; Oral and Gastrointestinal - Inflammatory bowel disease; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12618000179235
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-05
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Ulcerative Colitis (UC) or Crohn’s Disease (CD) of 3 months or greater duration.
2. Inactive to moderately active disease state based on scores from the Total Mayo Scoring Index for UC (scores of 0 to 10) and Crohn’s Disease Activity Index (CDAI) for CD (scores of 0 to 450). This change was made prior to any enrolments.

Exclusion Criteria

1.Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine .
2.Planned major surgery within the first 3 months after randomisation.
3.Clinical evidence of any comorbid chronic disease that may interfere with the patient’s ability to enter the trial and undertake the testing and exercise intervention planned
4.Pregnant
5.Female planning pregnancy within the first 4 months after randomisation.
6.Participating in moderate aerobic training equal or greater than 150 minutes per week or vigorous aerobic training equal or greater than 75 minutes per week, or high intensity interval training
7.Those currently practicing resistance training, of any intensity equal or greater than one day per week
8.Participation in another clinical trial for which concurrent participation is deemed inappropriate

Participants will be ineligible for the investigation of gut microbiota changes (therefore not required to give stool samples) if they have the following due to the influence on altering the gut microbiome:

1.Prior or concomitant/planned fecal microbiota transplantation or any rectal preparations for IBD currently
2.Probiotics during the study period or in the preceding 12 weeks
3.Significant prior gastrointestinal surgery (e.g., colon resection, fistula repair, bariatric surgery)

Study & Design

• Study Type: Interventional
• Study Design: Not specified