Developing a safe and effective exercise programme for people with Crohn’s Disease

Not Applicable

Completed

• Conditions: Topic: Gastroenterology; Subtopic: Gastroenterology; Disease: All Gastroenterology; Digestive System; Crohn's disease

• Registration Number: ISRCTN13021107
• Lead Sponsor: niversity of Hertfordshire

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28373911 protocol 2019 Results article in https://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-019-0936-x results (added 20/08/2020) 2019 Results article in https://doi.org/10.1371/journal.pone.0222060 Affective and enjoyment responses (added 04/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-02
• Study Completion: 2017-12-31
• Last Update Posted: 16 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Recruitment rates are calculated when the recruitment period is complete<br> 2. Intervention adherence rates are calculated when intervention delivery period is complete<br> 3. Missing data rates are calculated when follow-up is complete<br> 4. Retention rates are calculated when follow-up is complete<br>