Topic: Gastroenterology
Conditions
Interventions
Participants are randomly allocated to one of three groups.
High-intensity training group: Participants will be invited to complete three exercise sessions each week for 12 consecutiv
Sponsors
University of Hertfordshire
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rates are calculated when the recruitment period is complete 2. Intervention adherence rates are calculated when intervention delivery period is complete 3. Missing data rates are calculated when follow-up is complete 4. Retention rates are calculated when follow-up is complete | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood markers of inflammation (e.g. IL-6, CRP) are measured at baseline and 13 week in all participants, and week 7 in exercise group participants 2. Body mass is determined at baseline and 13 weeks 3. Cardiorespiratory fitness (ventilatory threshold and peak oxygen uptake) is determined at baseline and 13 weeks 4. Disease symptoms are measured using the Crohn's Disease Activity Index at baseline and 13 weeks 5. Health status is measured using the EuroQol EQ-5D-5L questionnaire at baseline, 13 and 26 weeks 6. Bowel inflammation is dertermined by measuring faecal calprotectin at baseline and 13 weeks 7. Anxiety and depression are measured using the Hospital Anxiety and Depression Scale at baseline, 13 and 26 weeks 8. Fatigue is measured using the Inflammatory Bowel Disease Fatigue Scale at baseline, 13 and 26 weeks 9. Quality of life is measured using the Inflammatory Bowel Disease Quality of Life Questionnaire at baseline, 13 and 26 weeks 10. Physical activity is measured using the International Physical Activity Questionnaire at baseline, 13 and 26 weeks 11. Resting blood pressure is measured at baseline and 13 weeks 12. Resting heart rate is measured at baseline and 13 weeks 13. Waist circumference is measured at baseline and 13 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed