Clinical trial NCT02317094: Blood-flow Restricted Exercise in Inclusion Body Myositis
Official title: Low-intensity Blood-flow Restricted Muscle Exercise in Patients With Sporadic Inclusion Body Myositis: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sporadic Inclusion Body Myositis
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2014-12-15
Enrollment: 22
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patient reported physical function (health survey (SF-36) subscale: Physical Function)
timeFrame: 12 wks
Secondary outcomes:
measure: Myositis Disease Activity Assessment Tool (MDAAT)
timeFrame: 12 wks
measure: Myositis Damage Index
timeFrame: 12 wks
measure: Physician/Patient Global activity (VAS scale)
timeFrame: 12 wks
measure: Physician/Patient Global Damage (VAS scale)
timeFrame: 12 wks
measure: 2-min walk test
timeFrame: 12 wks
measure: Manual Muscle Testing (MMT)
timeFrame: 12 wks
measure: Chair rise
timeFrame: 12 wks
measure: Timed up & go
timeFrame: 12 wks
measure: Health assessment questionnaire (HAQ)
timeFrame: 12 wks
measure: Inclusion body myositis functional rating scale (IBMFRS)
timeFrame: 12 wks
Other outcomes:
measure: Blood samples
timeFrame: 12 wks
measure: Muscle biopsies
timeFrame: 12 wks
measure: Sway - Postural Balance (using force plate)
timeFrame: 12 wks
measure: Maximal isometric and dynamic knee extension muscle strength (Kin-Com dynamometer)
timeFrame: 12 wks
measure: Leg extension muscle power (Nottingham Power Rig)
timeFrame: 12 wks
measure: Central activation (assessed with the twitch interpolation technique)
timeFrame: 12 wks
measure: Body composition ( full body duel energy X-ray absorption scan)
timeFrame: 12 wks
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital (OUH)
state: Fyn
Study officials:
affiliation: University of Southern Denmark
name: Anders N Jørgensen, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
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