Blood-flow Restricted Exercise in Inclusion Body Myositis

Not Applicable

Completed

• Conditions: Sporadic Inclusion Body Myositis
• Interventions: Drug: Care as usual; Other: Blood-flow restricted training

• Registration Number: NCT02317094
• Lead Sponsor: University of Southern Denmark

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-12
• Study First Posted: 2014-12-15
• Study Start: 2015-01
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Care as usual	Participants receive care as usual (various DMARDs, different from patient to patient).
Blood-flow restricted tranining	Blood-flow restricted training	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.
Blood-flow restricted tranining	Care as usual	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.

Primary Outcome Measures

Name	Time	Method
Patient reported physical function (health survey (SF-36) subscale: Physical Function)	12 wks	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.

Secondary Outcome Measures

Name	Time	Method
Myositis Damage Index	12 wks	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.
Myositis Disease Activity Assessment Tool (MDAAT)	12 wks	An assessment tool used by the physician to evaluate disease activity in various organ systems via a scoring system and VAS scales.
Physician/Patient Global activity (VAS scale)	12 wks	A VAS scale used by both physician and patient to evaluate the overall activity of the disease
Physician/Patient Global Damage (VAS scale)	12 wks	A VAS scale used by both physician and patient to evaluate the overall damage caused by the disease.
2-min walk test	12 wks	A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible.
Manual Muscle Testing (MMT)	12 wks	A test of muscle strength in a series of muscles, carried out by the physician
Chair rise	12 wks	Participants are instructed to stand up and sit down on a chair as many times as possible in 30 sec.
Timed up & go	12 wks	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
Health assessment questionnaire (HAQ)	12 wks	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.
Inclusion body myositis functional rating scale (IBMFRS)	12 wks	A disease specific questionnaire evaluating the patients self reported everyday function.

Trial Locations

Locations (1)

Odense University Hospital (OUH); 🇩🇰 Odense, Fyn, Denmark