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Blood-flow Restricted Exercise in Inclusion Body Myositis

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ClinicalTrials.gov Identifier: NCT02317094
Recruitment Status : Completed
First Posted : December 15, 2014
Last Update Posted : October 20, 2015
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Anders Nørkær Jørgensen, 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.

Condition or disease Intervention/treatment Phase
Sporadic Inclusion Body Myositis Other: Blood-flow restricted training Drug: Care as usual Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-intensity Blood-flow Restricted Muscle Exercise in Patients With Sporadic Inclusion Body Myositis: a Randomised Controlled Trial
Study Start Date : January 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Control
Participants receive care as usual (various DMARDs, different from patient to patient).
Drug: Care as usual
The intervention consists of various DMARDs, which are given to the patients depending on their physical state and the disease activity.

Experimental: Blood-flow restricted tranining
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
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).

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317094


Locations
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Denmark
Odense University Hospital (OUH)
Odense, Fyn, Denmark, 5230
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Investigators
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Principal Investigator: Anders N Jørgensen, PhD Student University of Southern Denmark

Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Anders Nørkær Jørgensen, MSc. Sports Science, PhD student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02317094     History of Changes
Other Study ID Numbers: S-20120166
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
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Myositis
Myositis, Inclusion Body
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases