Blood-flow Restricted Exercise in Inclusion Body Myositis

Sporadic Inclusion Body Myositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317094
• Other study ID #: S-20120166
• Status: Completed
• Phase: N/A
• First received: December 10, 2014
• Last updated: October 19, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myositis
• Myositis, Inclusion Body
• Sporadic Inclusion Body Myositis

Intervention

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.

Locations

Country	Name	City	State
Denmark	Odense University Hospital (OUH)	Odense	Fyn

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Gualano B, Neves M Jr, Lima FR, Pinto AL, Laurentino G, Borges C, Baptista L, Artioli GG, Aoki MS, Moriscot A, Lancha AH Jr, Bonfá E, Ugrinowitsch C. Resistance training with vascular occlusion in inclusion body myositis: a case study. Med Sci Sports Exer — View Citation

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. — View Citation

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.

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. — View Citation

Shield A, Zhou S. Assessing voluntary muscle activation with the twitch interpolation technique. Sports Med. 2004;34(4):253-67. Review. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood samples	Blood samples will be drawn for storage in a bio bank, for future analysis.	12 wks	No
Other	Muscle biopsies	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.	12 wks	No
Other	Sway - Postural Balance (using force plate)	A test of postural balance	12 wks	No
Other	Maximal isometric and dynamic knee extension muscle strength (Kin-Com dynamometer)	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)	12 wks	No
Other	Leg extension muscle power (Nottingham Power Rig)	The Nottingham Power Rig is used for evaluating the maximal muscle power that can be generated in the leg extensors.	12 wks	No
Other	Central activation (assessed with the twitch interpolation technique)	Voluntary muscle activation will be assessed with the twitch interpolation technique.	12 wks	No
Other	Body composition ( full body duel energy X-ray absorption scan)	Body composition will be evaluated with a full body duel energy X-ray absorption scan.	12 wks	No
Primary	Patient reported physical function (health survey (SF-36) subscale: Physical Function)	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.	12 wks	No
Secondary	Myositis Disease Activity Assessment Tool (MDAAT)	An assessment tool used by the physician to evaluate disease activity in various organ systems via a scoring system and VAS scales.	12 wks	No
Secondary	Myositis Damage Index	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.	12 wks	No
Secondary	Physician/Patient Global activity (VAS scale)	A VAS scale used by both physician and patient to evaluate the overall activity of the disease	12 wks	No
Secondary	Physician/Patient Global Damage (VAS scale)	A VAS scale used by both physician and patient to evaluate the overall damage caused by the disease.	12 wks	No
Secondary	2-min walk test	A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible.	12 wks	No
Secondary	Manual Muscle Testing (MMT)	A test of muscle strength in a series of muscles, carried out by the physician	12 wks	No
Secondary	Chair rise	Participants are instructed to stand up and sit down on a chair as many times as possible in 30 sec.	12 wks	No
Secondary	Timed up & go	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	12 wks	No
Secondary	Health assessment questionnaire (HAQ)	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.	12 wks	No
Secondary	Inclusion body myositis functional rating scale (IBMFRS)	A disease specific questionnaire evaluating the patients self reported everyday function.	12 wks	No

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