Blood-flow Restricted Exercise in Inclusion Body Myositis

University of Southern Denmark (SDU)

Status: Completed

Conditions: Sporadic Inclusion Body Myositis

Treatments: Drug: Care as usual; Other: Blood-flow restricted training

Study type: Interventional

Funder types: Other

Identifiers

NCT02317094

S-20120166

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Control

Other group

Description:

Participants receive care as usual (various DMARDs, different from patient to patient).

Treatment:

Drug: Care as usual

Blood-flow restricted tranining

Experimental group

Description:

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.

Treatment:

Drug: Care as usual

Other: Blood-flow restricted training