High-intensity Strength Training in Myositis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2023-01-01

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.

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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.

Conditions

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Myositis Dermatomyositis Polymyositis Immune-Mediated Necrotizing Myopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

High-intensity strength training

Intervention Type 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.

Control

Participants receive the usual care in accordance to myositis (various DMARDs, different from patient to patient).

Intervention:

Drug: Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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High-intensity resistance training

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No