Clinical trial NCT04486261: High-intensity Strength Training in Myositis
Official title: High-intensity Strength Training in Patients With Idiopathic Inflammatory Myopathies: Changes in Quality of Life, Muscle Strength, Function and Myocellular Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myositis
Dermatomyositis
Polymyositis
Immune-Mediated Necrotizing Myopathy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Odense University Hospital
First posted: 2020-07-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of a high-intensity strength training in patients with myositis with the primary outcome being quality of life (SF-36). The study is designed as a parallel group randomised controlled trial with an intervention group and a control group.

Detailed description: Overall aim:

To investigate the effect of high-intensity strength training on quality of life, muscle strength, physical function, and disease activity in patients with myositis

Study design:

60 myositis patients will be included in a 16-week high-intensity strength training study. Patients will be randomly allocated into 2 groups (strength training and control) in a 1:1 ratio.

User involvement:

Myositis patients has been recruited to a patient advisory board. The advisory board's objective is to give patient-oriented project feedback, thus improving the overall research project.

Intervention:

Two training session per week for 16 weeks. Sessions consists of 3 sets of each exercise corresponding to 10 RM. Training progression will be accounted for and training loads will be evaluated weekly. The training protocol will be a full-body protocol, i.e. all major muscle groups will be engaged during each training session.

Outcomes:

The primary outcome is the Physical Component Summary Measure from the quality of life questionnaire (SF-36). Secondary outcomes include strength measures, functional tests, disease activity measures, questionnaires (e.g. International physical activity questionnaire), DEXA whole body scans, blood samples and muscle biopsies.

Eligibility criteria: Inclusion Criteria:

* Fulfilling the criteria for myositis by EULAR/ACR (Bottai et al., 2017; Lundberg et al., 2017)
* ≤ 5 mg/day Prednisolone
* Stable dosage of immunosuppressive treatment for at least 1 months prior to inclusion in the study
* Myositis diagnosis at least 6 months prior to inclusion in the study

Exclusion Criteria:

* Patients with sporadic inclusion body myositis and overlap myositis (myositis combined with another autoimmune rheumatic diseases, except Sjögren's Syndrome)
* Co-morbidity preventing resistance training (severe heart/lung-disease, uncontrolled hypertension (systolic \> 160mmHg, diastolic \> 100mmHg), severe knee/hip arthritis)
* Alcohol- and/or drug abuse. Defined by the guidelines issued by The Danish Health Authority

Primary outcomes:
measure: Quality of life (health survey (SF-36) subscale: Physical Component Summary)
timeFrame: 16 weeks
Secondary outcomes:
measure: Leg power
timeFrame: 16 weeks
measure: Handgrip strength
timeFrame: 16 weeks
measure: Functional Index 3
timeFrame: 16 weeks
measure: 30 seconds chair rise
timeFrame: 16 weeks
measure: Timed up-and-go
timeFrame: 16 weeks
measure: 2-minute walk test
timeFrame: 16 weeks
measure: Balance
timeFrame: 16 weeks
measure: Whole-body, appendicular and lower-limb lean mass
timeFrame: 16 weeks
measure: Fat-free mass, body fat and total mass
timeFrame: 16 weeks
measure: Physician Global Activity
timeFrame: 16 weeks
measure: Patient Global Activity
timeFrame: 16 weeks
measure: Extra-muscular Disease Activity
timeFrame: 16 weeks
measure: Manual muscle test 8
timeFrame: 16 weeks
measure: Health Assessment Questionnaire (HAQ)
timeFrame: 16 weeks
measure: Physician Global assessment of disease damage
timeFrame: 16 weeks
measure: Patient Global assessment of disease damage
timeFrame: 16 weeks
measure: Medical history
timeFrame: 16 weeks
measure: Self-perceived physical activity levels
timeFrame: 16 weeks
measure: Quality of life (health survey (SF-36) subscale: Mental component summary)
timeFrame: 16 weeks
measure: Body mass index (BMI)
timeFrame: 16 weeks
measure: Systolic and diastolic blood pressure
timeFrame: 16 weeks
measure: Blood samples (analysis of markers of af disease activity)
timeFrame: 16 weeks
measure: Electrocardiography (ECG)
timeFrame: 16 weeks
Other outcomes:
measure: Muscle biopsies
timeFrame: 16 weeks
measure: Physical activity level
timeFrame: 16 weeks
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Louise Pyndt Diederichsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bottai M, Tjarnlund A, Santoni G, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinka M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Wook Song Y, Vencovsky J, Ytterberg SR, Miller FW, Rider LG, Lundberg IE; International Myositis Classification Criteria Project consortium, the Euromyositis register and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (JDRG) (UK and Ireland). EULAR/ACR classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups: a methodology report. RMD Open. 2017 Nov 14;3(2):e000507. doi: 10.1136/rmdopen-2017-000507. eCollection 2017.
citation: Lundberg IE, Tjarnlund A, Bottai M, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinska M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Song YW, Vencovsky J, Ytterberg SR, Miller FW, Rider LG; International Myositis Classification Criteria Project Consortium, the Euromyositis Register, and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (UK and Ireland). 2017 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies and Their Major Subgroups. Arthritis Rheumatol. 2017 Dec;69(12):2271-2282. doi: 10.1002/art.40320. Epub 2017 Oct 27.
citation: Jensen KY, Aagaard P, Schroder HD, Suetta C, Nielsen JL, Boyle E, Diederichsen LP. High-intensity strength training in patients with idiopathic inflammatory myopathies: a randomised controlled trial protocol. BMJ Open. 2021 Jun 25;11(6):e043793. doi: 10.1136/bmjopen-2020-043793.