An interventional study of High-intensity strength training in Myositis, Dermatomyositis and Polymyositis, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
Participants receive the usual care in accordance to myositis (various DMARDs, different from patient to patient). Intervention: Drug: Usual care
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.
Also known as: High-intensity resistance training
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.
Time frame: 16 weeks
Leg power
Power rig
Time frame: 16 weeks
Handgrip strength
Measured by a handheld dynamometer
Time frame: 16 weeks
Functional Index 3
A test of muscle strength in a series of muscles, carried out by the physician or physiotherapist
Time frame: 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.
Time frame: 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
Time frame: 16 weeks
2-minute walk test
A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible.
Time frame: 16 weeks
Balance
Short physical performance battery - balance part
Time frame: 16 weeks
Whole-body, appendicular and lower-limb lean mass
Measured by Dual-energy X-ray absorptiometry
Time frame: 16 weeks
Fat-free mass, body fat and total mass
Measured by bioimpedance
Time frame: 16 weeks
Physician Global Activity
Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity
Time frame: 16 weeks
Patient Global Activity
Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity.
Time frame: 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.
Time frame: 16 weeks
Manual muscle test 8
A test of muscle strength in a series of muscles, carried out by the physician
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 weeks
Medical history
Questionnaire: Basic cardiovascular questionnaire concerning medical conditions, current medication, heart symptoms and smoking habits
Time frame: 16 weeks
Self-perceived physical activity levels
International Physical Activity Questionnaire - long
Time frame: 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.
Time frame: 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)
Time frame: 16 weeks
Systolic and diastolic blood pressure
Measured by blood pressure monitor
Time frame: 16 weeks
Blood samples (analysis of markers of af disease activity)
Plasma analysis: lipid profile, HbA1c, troponins, NT-proBNP, creatine kinase
Time frame: 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.
Time frame: 16 weeks
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.
Time frame: 16 weeks
Physical activity level
Will be measured by activity tracker (watch)
Time frame: 16 weeks
Plan to share: No — Due to GDPR-regulations IPD will not be available.
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Rigshospitalet, Denmark