NCT02317094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

8 months

First QC Date

December 10, 2014

Last Update Submit

October 19, 2015

Conditions

Sporadic Inclusion Body Myositis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (10)

  • Myositis Disease Activity Assessment Tool (MDAAT)

    12 wks

  • Myositis Damage Index

    12 wks

  • Physician/Patient Global activity (VAS scale)

    12 wks

  • Physician/Patient Global Damage (VAS scale)

    12 wks

  • 2-min walk test

    12 wks

  • +5 more secondary outcomes

Other Outcomes (7)

  • Blood samples

    12 wks

  • Muscle biopsies

    12 wks

  • Sway - Postural Balance (using force plate)

    12 wks

  • +4 more other outcomes

Study Arms (2)

Control

OTHER

Participants receive care as usual (various DMARDs, different from patient to patient).

Drug: Care as usual

Blood-flow restricted tranining

EXPERIMENTAL

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 trainingDrug: Care as usual

Interventions

Blood-flow restricted trainingOTHER

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).

Blood-flow restricted tranining
Care as usualDRUG

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

Blood-flow restricted traniningControl

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital (OUH)

Odense, Fyn, 5230, Denmark

Location

Related Publications (14)

  • 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.

    PMID: 20074951BACKGROUND

  • 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.

    PMID: 22467380BACKGROUND

  • 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.

    PMID: 7486861BACKGROUND

  • 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.

    PMID: 3989241BACKGROUND

  • 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.

    PMID: 2369911BACKGROUND

  • 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.

    PMID: 12235031BACKGROUND

  • 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.

    PMID: 7484168BACKGROUND

  • 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.

    PMID: 15049717BACKGROUND

  • 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.

    PMID: 22246869BACKGROUND

  • 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.

    PMID: 12610846RESULT

  • 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.

    PMID: 9324080RESULT

  • 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.

    PMID: 19927034RESULT

  • 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.

    RESULT

  • 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.

    PMID: 35595645DERIVED

Related Links

MeSH Terms

Conditions

Myositis, Inclusion Body

Condition Hierarchy (Ancestors)

MyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Anders N Jørgensen, PhD Student

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc. Sports Science, PhD student

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 15, 2014

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 20, 2015

Record last verified: 2015-10

Locations

DK(1)