Low-intensity Blood-flow Restricted Muscle Exercise in Patients With Sporadic Inclusion Body Myositis: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Patient reported physical function (health survey (SF-36) subscale: Physical Function)
研究概览
简要总结
This study evaluates the effects of a low-intensity blood-flow restricted exerciser protocol on patient reported physical function, in patients with sporadic inclusion body myositis. The study is designed as a parallel group randomized controlled trial with a treatment group and a control group.
详细描述
Sporadic inclusion body myositis (sIBM) is a disease characterized by skeletal muscle inflammation and severe muscle atrophy especially in the muscles in the thigh and the finger flexors. In time the muscle weakness will cause the affected person to become unable to walk and carry out basic tasks in the every day life.
Currently no effective treatment exist for sIBM patients, however several studies indicate that exercise may be beneficial for the patients.
In the resent years a lot of research attention has been directed toward low-intensity training with partial vascular occlusion as an alternative to the conventional high intensity strength training. Interestingly the low-intensity blood-flow occluded training is found to be at least as beneficial in causing muscle growth as the conventional strength training but with very little mechanical load on joints and tendons. Furthermore the blood-flow occluded training seem to result in a hyper-activation of muscle stem cells which play an important role in muscle regeneration.
This make the blood-flow restricted training modality a very interesting treatment possibility for sIBM patients because it might be able to restore and/or maintain the skeletal muscle tissue and therefore also muscle function.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical features
- •Duration of weakness > 12 months
- •Weakness of finger flexors > shoulder abductors AND knee extension > hip flexion
- •Pathologic features
- •Invasion of nonnecrotic fibres of mononuclear cells or rimmed vacuoles or
- •increased major histocompatibility complex I (MHC-1) but no intracellular amyloid deposits or 15-18nm filaments
排除标准
- •Lack of gait function
- •Co-morbidity contraindicating the use of blood-flow restricted training (previous deep vein thrombosis/pulmonary embolism or known peripheral ischemic disease).
- •Co-morbidity preventing resistance training (severe heart/lung-disease, uncontrolled hypertension (systolic > 160mmHg, diastolic > 100mmHg), severe knee/hip arthritis)
研究组 & 干预措施
Control
Participants receive care as usual (various DMARDs, different from patient to patient).
干预措施: Care as usual (Drug)
Blood-flow restricted tranining
Participants will receive care as usual (various DMARDs, different from patient to patient) + 12 wks of low-intensity blood-flow restricted training twice per week.
干预措施: Blood-flow restricted training (Other)
Blood-flow restricted tranining
Participants will receive care as usual (various DMARDs, different from patient to patient) + 12 wks of low-intensity blood-flow restricted training twice per week.
干预措施: Care as usual (Drug)
结局指标
主要结局
Patient reported physical function (health survey (SF-36) subscale: Physical Function)
时间窗: 12 wks
Patient reported physical function will be evaluated with the short form (36) health survey (SF-36) subscale: Physical Function. The scale ranges from 0 to 100 where 100 is the highest score.
次要结局
- Myositis Disease Activity Assessment Tool (MDAAT)(12 wks)
- Myositis Damage Index(12 wks)
- Physician/Patient Global activity (VAS scale)(12 wks)
- Physician/Patient Global Damage (VAS scale)(12 wks)
- 2-min walk test(12 wks)
- Manual Muscle Testing (MMT)(12 wks)
- Chair rise(12 wks)
- Timed up & go(12 wks)
- Health assessment questionnaire (HAQ)(12 wks)
- Inclusion body myositis functional rating scale (IBMFRS)(12 wks)
研究者
Anders Nørkær Jørgensen
MSc. Sports Science, PhD student
University of Southern Denmark