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Clinical Trial Summary

This study evaluates the effects of a low-intensity blood-flow restricted exerciser protocol on patient reported physical function, in patients with sporadic inclusion body myositis. The study is designed as a parallel group randomized controlled trial with a treatment group and a control group.


Clinical Trial Description

Sporadic inclusion body myositis (sIBM) is a disease characterized by skeletal muscle inflammation and severe muscle atrophy especially in the muscles in the thigh and the finger flexors. In time the muscle weakness will cause the affected person to become unable to walk and carry out basic tasks in the every day life.

Currently no effective treatment exist for sIBM patients, however several studies indicate that exercise may be beneficial for the patients.

In the resent years a lot of research attention has been directed toward low-intensity training with partial vascular occlusion as an alternative to the conventional high intensity strength training. Interestingly the low-intensity blood-flow occluded training is found to be at least as beneficial in causing muscle growth as the conventional strength training but with very little mechanical load on joints and tendons. Furthermore the blood-flow occluded training seem to result in a hyper-activation of muscle stem cells which play an important role in muscle regeneration.

This make the blood-flow restricted training modality a very interesting treatment possibility for sIBM patients because it might be able to restore and/or maintain the skeletal muscle tissue and therefore also muscle function. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02317094
Study type Interventional
Source University of Southern Denmark
Contact
Status Completed
Phase N/A
Start date January 2015
Completion date September 2015

See also
  Status Clinical Trial Phase
Completed NCT01925209 - Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients Phase 2/Phase 3
Active, not recruiting NCT05046821 - Sporadic Inclusion Body Myositis Natural History Study
Completed NCT02573467 - An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203 Phase 3
Not yet recruiting NCT02735447 - Evidence Generation for Improving Life of People With sIBM: The ENGAGE Study N/A
Completed NCT01519349 - Follistatin Gene Transfer to Patients With Becker Muscular Dystrophy and Sporadic Inclusion Body Myositis Phase 1
Withdrawn NCT03710941 - Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis Phase 2
Completed NCT01423110 - Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis Phase 2
Completed NCT04421677 - Safety and Tolerability of Phenylbutyrate in Inclusion Body Myositis Phase 1