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Completed

NCT Number: NCT04486261

High-intensity Strength Training in Myositis

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.

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Key information

Conditions

Myositis Connective Tissue Diseases Dermatomyositis Immune-Mediated Necrotizing Myopathy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Polymyositis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity strength training

Other

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.

Other names: High-intensity resistance training

Primary outcomes

  1. Quality of life (health survey (SF-36) subscale: Physical Component Summary)

    Time frame: 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 outcomes

  1. Leg power

    Time frame: 16 weeks

    Power rig

  2. Handgrip strength

    Time frame: 16 weeks

    Measured by a handheld dynamometer

  3. Functional Index 3

    Time frame: 16 weeks

    A test of muscle strength in a series of muscles, carried out by the physician or physiotherapist

  4. 30 seconds chair rise

    Time frame: 16 weeks

    Participants are instructed to stand up and sit down on a chair as many times as possible in 30 sec.

  5. Timed up-and-go

    Time frame: 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

  6. 2-minute walk test

    Time frame: 16 weeks

    A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible.

  7. Balance

    Time frame: 16 weeks

    Short physical performance battery - balance part

  8. Whole-body, appendicular and lower-limb lean mass

    Time frame: 16 weeks

    Measured by Dual-energy X-ray absorptiometry

  9. Fat-free mass, body fat and total mass

    Time frame: 16 weeks

    Measured by bioimpedance

  10. Physician Global Activity

    Time frame: 16 weeks

    Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity

  11. Patient Global Activity

    Time frame: 16 weeks

    Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity.

  12. Extra-muscular Disease Activity

    Time frame: 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.

  13. Manual muscle test 8

    Time frame: 16 weeks

    A test of muscle strength in a series of muscles, carried out by the physician

  14. Health Assessment Questionnaire (HAQ)

    Time frame: 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.

  15. Physician Global assessment of disease damage

    Time frame: 16 weeks

    Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease damage.

  16. Patient Global assessment of disease damage

    Time frame: 16 weeks

    Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease damage.

  17. Medical history

    Time frame: 16 weeks

    Questionnaire:

    Basic cardiovascular questionnaire concerning medical conditions, current medication, heart symptoms and smoking habits

  18. Self-perceived physical activity levels

    Time frame: 16 weeks

    International Physical Activity Questionnaire - long

  19. Quality of life (health survey (SF-36) subscale: Mental component summary)

    Time frame: 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.

  20. Body mass index (BMI)

    Time frame: 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)

  21. Systolic and diastolic blood pressure

    Time frame: 16 weeks

    Measured by blood pressure monitor

  22. Blood samples (analysis of markers of af disease activity)

    Time frame: 16 weeks

    Plasma analysis: lipid profile, HbA1c, troponins, NT-proBNP, creatine kinase

  23. Electrocardiography (ECG)

    Time frame: 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.

Other outcomes

  1. Muscle biopsies

    Time frame: 16 weeks

    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.

  2. Physical activity level

    Time frame: 16 weeks

    Will be measured by activity tracker (watch)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Odense University Hospital
  • University of Southern Denmark

Registry information

Official study title

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

Acronym: HI-STIM

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 24, 2020
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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