- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02317094
Blood-flow Restricted Exercise in Inclusion Body Myositis
Low-intensity Blood-flow Restricted Muscle Exercise in Patients With Sporadic Inclusion Body Myositis: a Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Fyn
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Odense, Fyn, Denmark, 5230
- Odense University Hospital (OUH)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control
Participants receive care as usual (various DMARDs, different from patient to patient).
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The intervention consists of various DMARDs, which are given to the patients depending on their physical state and the disease activity.
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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.
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The intervention consists of various DMARDs, which are given to the patients depending on their physical state and the disease activity.
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient reported physical function (health survey (SF-36) subscale: Physical Function)
Time Frame: 12 wks
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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.
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12 wks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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12 wks
|
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.
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12 wks
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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
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12 wks
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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.
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12 wks
|
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.
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12 wks
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Manual Muscle Testing (MMT)
Time Frame: 12 wks
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A test of muscle strength in a series of muscles, carried out by the physician
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12 wks
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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.
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12 wks
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Timed up & go
Time Frame: 12 wks
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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
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12 wks
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Health assessment questionnaire (HAQ)
Time Frame: 12 wks
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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.
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12 wks
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Inclusion body myositis functional rating scale (IBMFRS)
Time Frame: 12 wks
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A disease specific questionnaire evaluating the patients self reported everyday function.
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12 wks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood samples
Time Frame: 12 wks
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Blood samples will be drawn for storage in a bio bank, for future analysis.
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12 wks
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Muscle biopsies
Time Frame: 12 wks
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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.
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12 wks
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Sway - Postural Balance (using force plate)
Time Frame: 12 wks
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A test of postural balance
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12 wks
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Maximal isometric and dynamic knee extension muscle strength (Kin-Com dynamometer)
Time Frame: 12 wks
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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)
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12 wks
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Leg extension muscle power (Nottingham Power Rig)
Time Frame: 12 wks
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The Nottingham Power Rig is used for evaluating the maximal muscle power that can be generated in the leg extensors.
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12 wks
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Central activation (assessed with the twitch interpolation technique)
Time Frame: 12 wks
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Voluntary muscle activation will be assessed with the twitch interpolation technique.
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12 wks
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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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12 wks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anders N Jørgensen, PhD Student, University of Southern Denmark
Publications and helpful links
General Publications
- Hilton-Jones D, Miller A, Parton M, Holton J, Sewry C, Hanna MG. Inclusion body myositis: MRC Centre for Neuromuscular Diseases, IBM workshop, London, 13 June 2008. Neuromuscul Disord. 2010 Feb;20(2):142-7. doi: 10.1016/j.nmd.2009.11.003. Epub 2010 Jan 13. No abstract available.
- Alexanderson H. Exercise in inflammatory myopathies, including inclusion body myositis. Curr Rheumatol Rep. 2012 Jun;14(3):244-51. doi: 10.1007/s11926-012-0248-4.
- Griggs RC, Askanas V, DiMauro S, Engel A, Karpati G, Mendell JR, Rowland LP. Inclusion body myositis and myopathies. Ann Neurol. 1995 Nov;38(5):705-13. doi: 10.1002/ana.410380504. No abstract available.
- Era P, Heikkinen E. Postural sway during standing and unexpected disturbance of balance in random samples of men of different ages. J Gerontol. 1985 May;40(3):287-95. doi: 10.1093/geronj/40.3.287.
- Bassey EJ, Short AH. A new method for measuring power output in a single leg extension: feasibility, reliability and validity. Eur J Appl Physiol Occup Physiol. 1990;60(5):385-90. doi: 10.1007/BF00713504.
- Aagaard P, Simonsen EB, Andersen JL, Magnusson P, Dyhre-Poulsen P. Increased rate of force development and neural drive of human skeletal muscle following resistance training. J Appl Physiol (1985). 2002 Oct;93(4):1318-26. doi: 10.1152/japplphysiol.00283.2002.
- Aagaard P, Simonsen EB, Trolle M, Bangsbo J, Klausen K. Isokinetic hamstring/quadriceps strength ratio: influence from joint angular velocity, gravity correction and contraction mode. Acta Physiol Scand. 1995 Aug;154(4):421-7. doi: 10.1111/j.1748-1716.1995.tb09927.x.
- Shield A, Zhou S. Assessing voluntary muscle activation with the twitch interpolation technique. Sports Med. 2004;34(4):253-67. doi: 10.2165/00007256-200434040-00005.
- Lowes LP, Alfano L, Viollet L, Rosales XQ, Sahenk Z, Kaspar BK, Clark KR, Flanigan KM, Mendell JR, McDermott MP. Knee extensor strength exhibits potential to predict function in sporadic inclusion-body myositis. Muscle Nerve. 2012 Feb;45(2):163-8. doi: 10.1002/mus.22321.
- Arnardottir S, Alexanderson H, Lundberg IE, Borg K. Sporadic inclusion body myositis: pilot study on the effects of a home exercise program on muscle function, histopathology and inflammatory reaction. J Rehabil Med. 2003 Jan;35(1):31-5. doi: 10.1080/16501970306110.
- Spector SA, Lemmer JT, Koffman BM, Fleisher TA, Feuerstein IM, Hurley BF, Dalakas MC. Safety and efficacy of strength training in patients with sporadic inclusion body myositis. Muscle Nerve. 1997 Oct;20(10):1242-8. doi: 10.1002/(sici)1097-4598(199710)20:103.0.co;2-c.
- Gualano B, Neves M Jr, Lima FR, Pinto AL, Laurentino G, Borges C, Baptista L, Artioli GG, Aoki MS, Moriscot A, Lancha AH Jr, Bonfa E, Ugrinowitsch C. Resistance training with vascular occlusion in inclusion body myositis: a case study. Med Sci Sports Exerc. 2010 Feb;42(2):250-4. doi: 10.1249/MSS.0b013e3181b18fb8.
- Johnson LG, Collier KE, Edwards DJ, Philippe DL, Eastwood PR, Walters SE, Thickbroom GW, Mastaglia FL. Improvement in aerobic capacity after an exercise program in sporadic inclusion body myositis. J Clin Neuromuscul Dis. 2009 Jun;10(4):178-84. doi: 10.1097/CND.0b013e3181a23c86.
- Jensen KY, Nielsen JL, Schroder HD, Jacobsen M, Boyle E, Jorgensen AN, Bech RD, Frandsen U, Aagaard P, Diederichsen LP. Lack of muscle stem cell proliferation and myocellular hypertrophy in sIBM patients following blood-flow restricted resistance training. Neuromuscul Disord. 2022 Jun;32(6):493-502. doi: 10.1016/j.nmd.2022.04.006. Epub 2022 Apr 26.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-20120166
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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