Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology
Conditions
Interventions
Participants are randomly allocated to one of two groups. Those in the first group receive usual care only. Those in the second group receive usual care plus a six-month resistance training programme
Sponsors
Northumbria University Newcastle
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 16 years or older 2. Clinical diagnosis of Crohn’s disease for at least 4 weeks before screening visit 3. Inactive (<150 on Crohn’s Disease Activity Index [CDAI]) or mildly active (150-219 on CDAI) Crohn’s disease assessed no greater than 4 weeks before screening visit 4. Faecal calprotectin <250mcg/g recorded no greater than 4 weeks before screening visit 5. Stable medications for at least 4 weeks before 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 or co-morbidities to exercise testing and training as defined by the American College of Sports Medicine 2. Deemed unsuitable to undertake resistance exercise (assessed by gastroenterologist/physician) 3. Planned major surgery within the first 6 months after randomisation 4. Female planning pregnancy within the first 6 months after randomisation 5. Pregnant 6. Current participation in > 2 sessions/week of resistance exercise (self-reported) 7. Participation in another clinical trial for with concurrent participation is deemed inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Bone mineral density at the femoral neck, greater trochanter and lumbar spine (L2- L4) is measured using dual energy X-ray absorptiometry at baseline and 6 months 2. Maximum voluntary isometric and isokinetic strength of the elbow flexor and knee extensor muscles is measured using isokinetic dynamometry at baseline, 3 months and 6 months 3. Handgrip strength is measured using a handgrip dynamometer at baseline, 3 months and 6 months 4. Lower-limb muscle endurance is measured using the 30-second chair sit-to-stand test at baseline, 3 months and 6 months 5. Upper-limb muscle endurance is measured using the 30-s arm bicep curl test at baseline, 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life is measured using the Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ) at baseline, 3 months and 6 months 2. Health status is measured using the EuroQol 5-dimensions, 5-level questionnaire (EQ-5D-5L) at baseline, 3 months and 6 months 3. Fatigue is measured using the Inflammatory Bowel Disease Fatigue Scale (IBD-F) at baseline, 3 months and 6 months 4. Body mass is measured using balance beam scales at baseline and 6 months 5. Stature is measured using a stadiometer at baseline and 6 months 6. Disease activity is measured using the Crohn’s Disease Activity Index (CDAI) at baseline and 6 months 7. Bowel inflammation is determined by measuring faecal calprotectin at baseline and 6 months 8. Blood markers of inflammation (e.g. C-reactive protein) are measured at baseline and 6 months 9. Physical activity is measured using the Scottish Physical Activity Questionnaire (SPAQ) at baseline, 3 months and 6 months 10. Feasibility and acceptability outcomes will include rates of recruitment, retention, attrition, missing data, intervention adherence and adverse events, which will all be calculated once follow-up is complete | — |
Countries
England, United Kingdom
Outcome results
None listed