High-intensity Strength Training in Myositis (HI-STIM)

Rigshospitalet

Status: Completed

Conditions: Dermatomyositis; Myositis; Polymyositis; Immune-Mediated Necrotizing Myopathy

Treatments: Other: High-intensity strength training

Study type: Interventional

Funder types: Other

Identifiers

NCT04486261

MCT16072020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

High-intensity strength training

Experimental group

Description:

16 weeks of high-intensity strength training two times per week. Participants will receive the usual care in accordance to myositis (various DMARDs, different from patient to patient) Interventions: Other: high-intensity strength training Drug: Usual care

Treatment:

Other: High-intensity strength training

Control

No Intervention group

Description:

Participants receive the usual care in accordance to myositis (various DMARDs, different from patient to patient). Intervention: Drug: Usual care