High-intensity Strength Training in Patients With Idiopathic Inflammatory Myopathies: Changes in Quality of Life, Muscle Strength, Function and Myocellular Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Quality of life (health survey (SF-36) subscale: Physical Component Summary)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Quality of life (health survey (SF-36) subscale: Physical Component Summary)
时间窗: 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.
次要结局
- 30 seconds chair rise(16 weeks)
- Functional Index 3(16 weeks)
- Whole-body, appendicular and lower-limb lean mass(16 weeks)
- Fat-free mass, body fat and total mass(16 weeks)
- Balance(16 weeks)
- Physician Global Activity(16 weeks)
- Manual muscle test 8(16 weeks)
- Medical history(16 weeks)
- Leg power(16 weeks)
- Handgrip strength(16 weeks)
- Timed up-and-go(16 weeks)
- Health Assessment Questionnaire (HAQ)(16 weeks)
- Self-perceived physical activity levels(16 weeks)
- Body mass index (BMI)(16 weeks)
- Systolic and diastolic blood pressure(16 weeks)
- 2-minute walk test(16 weeks)
- Patient Global Activity(16 weeks)
- Extra-muscular Disease Activity(16 weeks)
- Electrocardiography (ECG)(16 weeks)
- Physician Global assessment of disease damage(16 weeks)
- Patient Global assessment of disease damage(16 weeks)
- Quality of life (health survey (SF-36) subscale: Mental component summary)(16 weeks)
- Blood samples (analysis of markers of af disease activity)(16 weeks)
研究者
Louise Pyndt Diederichsen
Consultant Rheumatologist, Associate professor
Rigshospitalet, Denmark