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

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

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.

Study Overview

• Status: Completed
• Conditions: Myositis; Dermatomyositis; Polymyositis; Immune-Mediated Necrotizing Myopathy
• Intervention / Treatment: Other: High-intensity strength training

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: High-intensity strength training; 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
No Intervention: Control; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks
Physical activity level	Will be measured by activity tracker (watch)	16 weeks

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Odense University Hospital; University of Southern Denmark
• Investigators: Principal Investigator: Louise Pyndt Diederichsen, PhD, Rigshospitalet, Denmark

Publications and helpful links

General Publications

• Bottai M, Tjarnlund A, Santoni G, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinka M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Wook Song Y, Vencovsky J, Ytterberg SR, Miller FW, Rider LG, Lundberg IE; International Myositis Classification Criteria Project consortium, the Euromyositis register and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (JDRG) (UK and Ireland). EULAR/ACR classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups: a methodology report. RMD Open. 2017 Nov 14;3(2):e000507. doi: 10.1136/rmdopen-2017-000507. eCollection 2017.
• Lundberg IE, Tjarnlund A, Bottai M, Werth VP, Pilkington C, de Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Garcia-De La Torre I, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinska M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Song YW, Vencovsky J, Ytterberg SR, Miller FW, Rider LG; International Myositis Classification Criteria Project Consortium, the Euromyositis Register, and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository (UK and Ireland). 2017 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies and Their Major Subgroups. Arthritis Rheumatol. 2017 Dec;69(12):2271-2282. doi: 10.1002/art.40320. Epub 2017 Oct 27. Erratum In: Arthritis Rheumatol. 2018 Sep;70(9):1532.
• Jensen KY, Aagaard P, Schroder HD, Suetta C, Nielsen JL, Boyle E, Diederichsen LP. High-intensity strength training in patients with idiopathic inflammatory myopathies: a randomised controlled trial protocol. BMJ Open. 2021 Jun 25;11(6):e043793. doi: 10.1136/bmjopen-2020-043793.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Neuromuscular Diseases; Muscular Diseases; Myositis; Dermatomyositis; Polymyositis
• Other Study ID Numbers: MCT16072020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to GDPR-regulations IPD will not be available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No