High-intensity Strength Training in Myositis

Study Overview
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Brief Summary
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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
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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.

Official Title
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High-intensity Strength Training in Patients With Idiopathic Inflammatory Myopathies: Changes in Quality of Life, Muscle Strength, Function and Myocellular Parameters

Conditions
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Myositis, Dermatomyositis, Polymyositis, Immune-Mediated Necrotizing Myopathy

Intervention / Treatment
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* Other: High-intensity strength training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-intensity strength training<br>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 | Other: High-intensity strength training<br>* The high-intensity strength training protocol will consist of 2 training sessions per week. The first two weeks will be familiarisation training, where each exercise will be performed in three sets of 10 repetitions at an intensity of 15 repetitions maximum (RM). At week three each session will consist of 3 sets of each exercise corresponding to 10 RM, which will be kept for the remaining part of training intervention. The weights for each exercise will be adjusted throughout the intervention period, so the training load will correspond to 10 RM for each exercise in the entire intervention period.<br>* Other names: High-intensity resistance training;|
| No Intervention: Control<br>Participants receive the usual care in accordance to myositis (various DMARDs, different from patient to patient). Intervention: Drug: Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (health survey (SF-36) subscale: Physical Component Summary) | Quality of life will be evaluated with the short form (36) health survey (SF-36) subscale: Physical Component Summary. The scale ranges from 0 to 100 where 100 is the highest score. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg power | Power rig | 16 weeks | 
| Handgrip strength | Measured by a handheld dynamometer | 16 weeks | 
| Functional Index 3 | A test of muscle strength in a series of muscles, carried out by the physician or physiotherapist | 16 weeks | 
| 30 seconds chair rise | Participants are instructed to stand up and sit down on a chair as many times as possible in 30 sec. | 16 weeks | 
| Timed up-and-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 | 16 weeks | 
| 2-minute walk test | A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible. | 16 weeks | 
| Balance | Short physical performance battery - balance part | 16 weeks | 
| Whole-body, appendicular and lower-limb lean mass | Measured by Dual-energy X-ray absorptiometry | 16 weeks | 
| Fat-free mass, body fat and total mass | Measured by bioimpedance | 16 weeks | 
| Physician Global Activity | Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity | 16 weeks | 
| Patient Global Activity | Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity. | 16 weeks | 
| Extra-muscular Disease Activity | An assessment tool used by the physician to evaluate disease activity in various organ systems via a scoring system and a 0-10 cm scale, where the higher score indicates higher disease activity. | 16 weeks | 
| Manual muscle test 8 | A test of muscle strength in a series of muscles, carried out by the physician | 16 weeks | 
| 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. | 16 weeks | 
| Physician Global assessment of disease damage | Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease damage. | 16 weeks | 
| Patient Global assessment of disease damage | Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease damage. | 16 weeks | 
| Medical history | Questionnaire: Basic cardiovascular questionnaire concerning medical conditions, current medication, heart symptoms and smoking habits | 16 weeks | 
| Self-perceived physical activity levels | International Physical Activity Questionnaire - long | 16 weeks | 
| Quality of life (health survey (SF-36) subscale: Mental component summary) | Quality of life will be evaluated with the short form (36) health survey (SF-36) subscale: Mental Component Summary. The scale ranges from 0 to 100 where 100 is the highest score. | 16 weeks | 
| Body mass index (BMI) | Weight will be measured by scale (kg). Height will be measured by measuring (m). BMI will be derived from weight and height (kg/m^2) | 16 weeks | 
| Systolic and diastolic blood pressure | Measured by blood pressure monitor | 16 weeks | 
| Blood samples (analysis of markers of af disease activity) | Plasma analysis: lipid profile, HbA1c, troponins, NT-proBNP, creatine kinase | 16 weeks | 
| Electrocardiography (ECG) | Standard 12-lead ECG at 25 mm/s is recorded and analyzed according to standard published criteria (48-50). According to the Minnesota coding the PQ-interval is measured and presence of 1st, 2nd (including Mobitz type 1 and 2), and 3rd degree of AV block are noted. Additional measures will include: P-wave duration (≥ 2.5 mm in any of leads II, III, aVF), QRS duration (≥ 120 ms in any of leads I, II, III, aVL, aVF), QTc duration (> 450 ms), atrial fibrillation and flutter. | 16 weeks |