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Clinical Trial Summary

This study evaluates the effects of a high-intensity strength training in patients with myositis with the primary outcome being quality of life (SF-36). The study is designed as a parallel group randomised controlled trial with an intervention group and a control group.


Clinical Trial Description

Overall aim: To investigate the effect of high-intensity strength training on quality of life, muscle strength, physical function, and disease activity in patients with myositis Study design: 60 myositis patients will be included in a 16-week high-intensity strength training study. Patients will be randomly allocated into 2 groups (strength training and control) in a 1:1 ratio. User involvement: Myositis patients has been recruited to a patient advisory board. The advisory board's objective is to give patient-oriented project feedback, thus improving the overall research project. Intervention: Two training session per week for 16 weeks. Sessions consists of 3 sets of each exercise corresponding to 10 RM. Training progression will be accounted for and training loads will be evaluated weekly. The training protocol will be a full-body protocol, i.e. all major muscle groups will be engaged during each training session. Outcomes: The primary outcome is the Physical Component Summary Measure from the quality of life questionnaire (SF-36). Secondary outcomes include strength measures, functional tests, disease activity measures, questionnaires (e.g. International physical activity questionnaire), DEXA whole body scans, blood samples and muscle biopsies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04486261
Study type Interventional
Source Rigshospitalet, Denmark
Contact
Status Completed
Phase N/A
Start date August 30, 2021
Completion date January 1, 2023

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