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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
The intervention consists of low-intensity blood-flow restricted training involving 5 lower extremity exercises performed uni lateral in four sets to concentric failure with an intensity of approximately 25 repetition maximum (25RM).
The intervention consists of various DMARDs, which are given to the patients depending on their physical state and the disease activity.
Odense University Hospital (OUH)
Odense, Fyn, Denmark
Patient reported physical function (health survey (SF-36) subscale: Physical Function)
Patient reported physical function will be evaluated with the short form (36) health survey (SF-36) subscale: Physical Function. The scale ranges from 0 to 100 where 100 is the highest score.
Time frame: 12 wks
Myositis Disease Activity Assessment Tool (MDAAT)
An assessment tool used by the physician to evaluate disease activity in various organ systems via a scoring system and VAS scales.
Time frame: 12 wks
Myositis Damage Index
An assessment tool used by the physician to evaluate the damage caused by the disease or co-morbid conditions, to various organ systems. The system uses VAS scales.
Time frame: 12 wks
Physician/Patient Global activity (VAS scale)
A VAS scale used by both physician and patient to evaluate the overall activity of the disease
Time frame: 12 wks
Physician/Patient Global Damage (VAS scale)
A VAS scale used by both physician and patient to evaluate the overall damage caused by the disease.
Time frame: 12 wks
2-min walk test
A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible.
Time frame: 12 wks
Manual Muscle Testing (MMT)
A test of muscle strength in a series of muscles, carried out by the physician
Time frame: 12 wks
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Chair rise
Participants are instructed to stand up and sit down on a chair as many times as possible in 30 sec.
Time frame: 12 wks
Timed up & go
Participants are instructed to rise from a chair walk 3 m forward, pass a marking and return to the chair and sit down as fast as possible
Time frame: 12 wks
Health assessment questionnaire (HAQ)
HAQ is a questionnaire to evaluate patient reported disability. It has 8 categories with a range of questions. Each question is scored from 0 to 3 where 0 is no disability and 3 is unable to do.
Time frame: 12 wks
Inclusion body myositis functional rating scale (IBMFRS)
A disease specific questionnaire evaluating the patients self reported everyday function.
Time frame: 12 wks