Blood-flow Restricted Exercise in Inclusion Body Myositis
NCT ID: NCT02317094
Last Updated: 2015-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2015-01-31
2015-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
Participants receive care as usual (various DMARDs, different from patient to patient).
Care as usual
The intervention consists of various DMARDs, which are given to the patients depending on their physical state and the disease activity.
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.
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).
Care as usual
The intervention consists of various DMARDs, which are given to the patients depending on their physical state and the disease activity.
Interventions
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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).
Care as usual
The intervention consists of various DMARDs, which are given to the patients depending on their physical state and the disease activity.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
35 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Anders Nørkær Jørgensen
MSc. Sports Science, PhD student
Principal Investigators
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Anders N Jørgensen, PhD Student
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Locations
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Odense University Hospital (OUH)
Odense, Fyn, Denmark
Countries
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References
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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, L.G., Edwards, D.J., Walters, S., Thickbroom, G.W., Mastaglia, F.L., The Effectiveness of an Individualized, Home-Based Functional Exercise Program for Patients With Sporadic Inclusion Body Myositis. J Clin Neuromuscul Dis 8(4): 187-194, 2007.
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.
Related Links
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Valuable knowledge about myositis diseases
Myositis evaluation tools
Other Identifiers
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S-20120166
Identifier Type: -
Identifier Source: org_study_id
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