Effects of a 6-month practical resistance training programme on muscle function and bone mineral density in adults with inactive or mildly active Crohn’s disease: Study protocol for a randomised controlled trial

orthumbria University Newcastle0 个研究点目标入组 47 人开始时间: 2017年12月12日最近更新: 2022年8月22日

试验速览

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33119156/ results (added 30/10/2020)

•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

•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

发起方

orthumbria University Newcastle