Blood-flow Restricted Exercise in Inclusion Body Myositis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Low-intensity Blood-flow Restricted Muscle Exercise in Patients With Sporadic Inclusion Body Myositis: a Randomised Controlled Trial

Conditions
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Sporadic Inclusion Body Myositis

Intervention / Treatment
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* Other: Blood-flow restricted training
* Drug: Care as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical features Duration of weakness > 12 months Weakness of finger flexors > shoulder abductors AND knee extension > hip flexion Pathologic features Invasion of nonnecrotic fibres of mononuclear cells or rimmed vacuoles or increased major histocompatibility complex I (MHC-1) but no intracellular amyloid deposits or 15-18nm filaments Exclusion Criteria: Lack of gait function Co-morbidity contraindicating the use of blood-flow restricted training (previous deep vein thrombosis/pulmonary embolism or known peripheral ischemic disease). Co-morbidity preventing resistance training (severe heart/lung-disease, uncontrolled hypertension (systolic > 160mmHg, diastolic > 100mmHg), severe knee/hip arthritis)

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Participants receive care as usual (various DMARDs, different from patient to patient). | Drug: Care as usual<br>* The intervention consists of various DMARDs, which are given to the patients depending on their physical state and the disease activity.<br>|
| Experimental: Blood-flow restricted tranining<br>Participants will receive care as usual (various DMARDs, different from patient to patient) + 12 wks of low-intensity blood-flow restricted training twice per week. | Other: Blood-flow restricted training<br>* 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).<br>Drug: Care as usual<br>* The intervention consists of various DMARDs, which are given to the patients depending on their physical state and the disease activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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. | 12 wks | 
| 2-min walk test | A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible. | 12 wks | 
| Manual Muscle Testing (MMT) | A test of muscle strength in a series of muscles, carried out by the physician | 12 wks | 
| Chair rise | Participants are instructed to stand up and sit down on a chair as many times as possible in 30 sec. | 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 | 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. | 12 wks | 
| Inclusion body myositis functional rating scale (IBMFRS) | A disease specific questionnaire evaluating the patients self reported everyday function. | 12 wks |