Resistance training in adults with Crohn’s disease

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: 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 involving a combination of supervised and unsupervised exercise sessions. Each session will begin with a five‐minute warm up, then approximately 45 minutes of whole‐body resistance training (using body weight and elastic bands for resistance), and a three‐minute cool down. At the start of the study, and then again at three and six months, participants complete a number of questionnaires and physical tests in order to find out if there has been any change to their muscle function, fatigue and quality of life. At the start of the study and at six months, participants are asked to provide a stool (faeces) sample so that the level of inflammation in their intestines can be assessed, as well as undertaking a bone scan to assess changes in bone mineral density. CONDITION: Specialty: Gastroenterology, Primary sub‐specialty: Gastroenterology; UKCRC code/ Disease: Oral and Gastrointestinal/ Other diseases of the digestive system ; Digestive System ; Oral and Gastrointestinal/ Other diseases of the digestive system PRIMARY OUTCOME: 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 OUTCOME: 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; 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
Epistemonikos ID: a8b7553f2dd3d01bcc8e88966b5fc09d2e0950c6
First added on: Aug 23, 2024