A randomised controlled trial investigating the feasibility and acceptability of high-intensity interval training and moderate-intensity continuous training in adults with inactive or mildly active Crohn’s disease

niversity of Hertfordshire0 sites36 target enrollmentDecember 2, 2015

Overview

Registry

who.int

Start Date

December 2, 2015

End Date

December 31, 2017

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Hertfordshire

•1\. Aged between 16 and 65 years
•2\. Clinical diagnosis of CD for at least 4 weeks before the screening visit
•3\. Mildly active (150 to 219 on Crohn’s Disease Activity Index \[CDAI]) or inactive (\<150 on CDAI) CD assessed no greater than 4 weeks before the screening visit
•4\. Faecal calprotectin \<250 mcg/g recorded no greater than 4 weeks before the screening visit
•5\. Stable medications for at least 4 weeks before the screening visit
•6\. Able to provide written informed consent and complete the study questionnaires
•7\. Able to travel to the research centre for assessment visits and exercise sessions

•1\.Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine
•2\. Coexistent serious autoimmune disease such as rheumatoid arthritis or systemic sclerosis
•3\. Planned major surgery within the first 3 months after randomisation
•4\. Pregnant
•5\. Female planning pregnancy within the first 3 months after randomisation
•6\. Poor tolerability of venepuncture
•7\. Lack of adequate venous access for required blood sampling
•8\. Current participation in more than 90 min/week of purposeful exercise, such as jogging or swimming
•9\. Participation in another clinical trial for with concurrent participation is deemed inappropriate