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Clinical Trials/ISRCTN11470370
ISRCTN11470370
Completed
未知

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 sites47 target enrollmentDecember 12, 2017
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
orthumbria University Newcastle
Enrollment
47
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
who.int
Start Date
December 12, 2017
End Date
October 31, 2019
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
orthumbria University Newcastle

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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