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NCT Number: NCT02317094

Blood-flow Restricted Exercise in Inclusion Body Myositis

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.

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Key information

Conditions

Sporadic Inclusion Body Myositis Muscular Diseases Musculoskeletal Diseases Myositis Myositis, Inclusion Body Nervous System Diseases Neuromuscular Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital (OUH)

Odense, Fyn, 5230, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood-flow restricted training

Other

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).

Care as usual

Drug

The intervention consists of various DMARDs, which are given to the patients depending on their physical state and the disease activity.

Primary outcomes

  1. Patient reported physical function (health survey (SF-36) subscale: Physical Function)

    Time frame: 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 outcomes

  1. Myositis Disease Activity Assessment Tool (MDAAT)

    Time frame: 12 wks

    An assessment tool used by the physician to evaluate disease activity in various organ systems via a scoring system and VAS scales.

  2. Myositis Damage Index

    Time frame: 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.

  3. Physician/Patient Global activity (VAS scale)

    Time frame: 12 wks

    A VAS scale used by both physician and patient to evaluate the overall activity of the disease

  4. Physician/Patient Global Damage (VAS scale)

    Time frame: 12 wks

    A VAS scale used by both physician and patient to evaluate the overall damage caused by the disease.

  5. 2-min walk test

    Time frame: 12 wks

    A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible.

  6. Manual Muscle Testing (MMT)

    Time frame: 12 wks

    A test of muscle strength in a series of muscles, carried out by the physician

  7. Chair rise

    Time frame: 12 wks

    Participants are instructed to stand up and sit down on a chair as many times as possible in 30 sec.

  8. Timed up & go

    Time frame: 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

  9. Health assessment questionnaire (HAQ)

    Time frame: 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.

  10. Inclusion body myositis functional rating scale (IBMFRS)

    Time frame: 12 wks

    A disease specific questionnaire evaluating the patients self reported everyday function.

Other outcomes

  1. Blood samples

    Time frame: 12 wks

    Blood samples will be drawn for storage in a bio bank, for future analysis.

  2. Muscle biopsies

    Time frame: 12 wks

    Muscle biopsies will be taken on a selected number of subjects from either the vastus lateralis or the tibialis anterior muscle, for the use in future analysis of i.e. muscle fibre size and distribution, myogenic stem cell activity, capillary density, muscle inflammation ect.

  3. Sway - Postural Balance (using force plate)

    Time frame: 12 wks

    A test of postural balance

  4. Maximal isometric and dynamic knee extension muscle strength (Kin-Com dynamometer)

    Time frame: 12 wks

    The maximal isometric and dynamic knee extension muscle strength will be evaluated in a Kin-Com dynamometer. Isometric strength data will be analyzed for peak torque, maximal impulse and maximal contractile rate of force development (RFD)

  5. Leg extension muscle power (Nottingham Power Rig)

    Time frame: 12 wks

    The Nottingham Power Rig is used for evaluating the maximal muscle power that can be generated in the leg extensors.

  6. Central activation (assessed with the twitch interpolation technique)

    Time frame: 12 wks

    Voluntary muscle activation will be assessed with the twitch interpolation technique.

  7. Body composition ( full body duel energy X-ray absorption scan)

    Time frame: 12 wks

    Body composition will be evaluated with a full body duel energy X-ray absorption scan.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Odense University Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 15, 2014
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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