High-intensity Strength Training in Myositis
- Conditions
- Immune-Mediated Necrotizing MyopathyDermatomyositisPolymyositisMyositis
- Interventions
- Other: High-intensity strength training
- Registration Number
- NCT04486261
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-intensity strength training High-intensity strength training 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
- Primary Outcome Measures
Name Time Method Quality of life (health survey (SF-36) subscale: Physical Component Summary) 16 weeks 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.
- Secondary Outcome Measures
Name Time Method 30 seconds chair rise 16 weeks Participants are instructed to stand up and sit down on a chair as many times as possible in 30 sec.
Functional Index 3 16 weeks A test of muscle strength in a series of muscles, carried out by the physician or physiotherapist
Whole-body, appendicular and lower-limb lean mass 16 weeks Measured by Dual-energy X-ray absorptiometry
Fat-free mass, body fat and total mass 16 weeks Measured by bioimpedance
Balance 16 weeks Short physical performance battery - balance part
Physician Global Activity 16 weeks Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity
Manual muscle test 8 16 weeks A test of muscle strength in a series of muscles, carried out by the physician
Medical history 16 weeks Questionnaire:
Basic cardiovascular questionnaire concerning medical conditions, current medication, heart symptoms and smoking habitsLeg power 16 weeks Power rig
Handgrip strength 16 weeks Measured by a handheld dynamometer
Timed up-and-go 16 weeks 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
Health Assessment Questionnaire (HAQ) 16 weeks 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.
Self-perceived physical activity levels 16 weeks International Physical Activity Questionnaire - long
Body mass index (BMI) 16 weeks 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)
Systolic and diastolic blood pressure 16 weeks Measured by blood pressure monitor
2-minute walk test 16 weeks A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible.
Extra-muscular Disease Activity 16 weeks 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.
Electrocardiography (ECG) 16 weeks 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.
Patient Global Activity 16 weeks Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity.
Physician Global assessment of disease damage 16 weeks Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease damage.
Patient Global assessment of disease damage 16 weeks Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease damage.
Quality of life (health survey (SF-36) subscale: Mental component summary) 16 weeks 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.
Blood samples (analysis of markers of af disease activity) 16 weeks Plasma analysis: lipid profile, HbA1c, troponins, NT-proBNP, creatine kinase
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark