The Effects of Exercise, Creatine, and Coenzyme Q10 Supplementation on Muscle Function in Children With Myositis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in muscle function
研究概览
简要总结
Children with Juvenile Idiopathic Inflammatory Myopathies (JIIM) are weak and get tired because their muscles aren't able to work like healthy muscles. This can make it hard for them to do normal everyday things and can make them less happy about their lives compared to children without the disease. There are two nutritional supplements that help muscles use energy and recover after exercise: creatine and coenzyme Q10. If the muscle has more energy, it may not be as weak and may not feel as tired or sore after exercise. Because of this we want to see if having children with JIIM take creatine and coenzyme Q10 can make them stronger and less tired. If this works, we hope it will let them be able to do the things that healthy children can do, and make them feel better about their lives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 7 to 18 years
- •Diagnosis of juvenile idiopathic inflammatory myopathy (JIIM) according to the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria: ≥90% probability, age of onset <18 years
- •Subjects on a stable course of medication (unlikely to change over study treatment period as determined by treating physician)
- •Minimum height of 132.5cm (required to fit on the cycle ergometer)
排除标准
- •Subjects with newly diagnosed JIIM within the previous 6 months
- •Subjects unable to cooperate with study procedures, or too weak to participate in the exercise testing
- •Subjects with impaired kidney function as determined from pre-baseline visit screening lab values (eGFR <90 ml/min/1.73m^2)
- •Subjects currently taking anti-hypertensive drugs or blood thinners
- •Subjects who are currently pregnant or planning to become pregnant within the study period
研究组 & 干预措施
Placebo
patients in this arm will be given placebo supplements that look and taste identical to the active supplements
干预措施: gel capsule (Dietary Supplement)
Placebo
patients in this arm will be given placebo supplements that look and taste identical to the active supplements
干预措施: Exercise (Behavioral)
Treatment
patients in this arm will be treated with creatine and coenzyme Q10 supplements
干预措施: creatine monohydrate (Dietary Supplement)
Treatment
patients in this arm will be treated with creatine and coenzyme Q10 supplements
干预措施: ubiquinol (Dietary Supplement)
Treatment
patients in this arm will be treated with creatine and coenzyme Q10 supplements
干预措施: Exercise (Behavioral)
Placebo
patients in this arm will be given placebo supplements that look and taste identical to the active supplements
干预措施: glucose tablet (Dietary Supplement)
结局指标
主要结局
Change in muscle function
时间窗: 6 months
Change in muscle function will be determined by the change in peak power achieved on the wingate anaerobic cycling test between the active supplement phase and the placebo phase
次要结局
- Change in general fatigue(6 months)
- Change in quality of life(6 months)
- Change in muscle fatigue(6 months)
- Change in physical function(6 months)
研究者
Brian M. Feldman
Division Head, Division of Rheumatology
The Hospital for Sick Children