Effect of Resistance and Aerobic Exercise on Muscle Strength, Aerobic Capacity and Quality of Life in Patients Treated With Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) or Multifocal Motor Neuropathy (MMN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Changes in maximal oxygen consumption (VO2-max)
研究概览
简要总结
Resistance and aerobic exercise has been shown to be effective for maintenance of muscle strength in patients with neuromuscular diseases.
Exercise in CIDP and MMN is sparsely described. The aim of the study is to evaluate changes in muscle strength during high intensive resistance training and changes in maximal oxygen consumption (VO2-max) during high intensive aerobic training in patients with CIDP or MMN in maintenance therapy with subcutaneous immunoglobulin.
The hypotheses are that muscle strength and VO2-max are significantly increased during the training sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and < 80 years
- •Diagnosed with definite or probable CIDP or definite or probable MMN fulfilling the European Federation of Neurological Sciences/Peripheral Nerve Society (EFNS/PNS) criteria
- •Stable maintenance therapy with immunoglobulin (no change of dosage < 3 months before inclusion)
- •Duration of CIDP or MMN > 6 months
- •Negative result on a pregnancy test (HCG-based assay in urine) for women of childbearing potential and use of a reliable method of contraception for the duration of the study
排除标准
- •Other cause of neuropathy (incl. pressure neuropathy)
- •Exercise before enrolment (> 1 hour of exercise per week or > 4 km bicycling per day)
- •Walking distance < 10 meter with or without aid
- •Diabetes mellitus, severe cardiac or pulmonary disease, malignancies
- •Known history of adverse reactions to Immunoglobulin A in other products
- •Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products.
- •History of malignancies of lymphoid cells and immunodeficiency with lymphoma
- •Known liver function impairment (ALAT 3 times above upper limit of normal)
- •Known protein-losing enteropathies or proteinuria.
- •Known of renal function impairment (creatinine >120 micromol/L or creatinine >1.35 mg/dL), or predisposition for acute renal failure (e.g., any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs).
- •Treatment with any investigational medicinal product within 3 months prior to first infusion of Gammanorm
- •Known or suspected HIV, Hepatitis Virus C or B infection
- •Pregnant or nursing women
- •Planned pregnancy during course of the study
结局指标
主要结局
Changes in maximal oxygen consumption (VO2-max)
时间窗: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks
VO2-max are measured during the 12 weeks aerobic exercise session and at enrolment 12 weeks before start of exercise. VO2-max are measured while the participant running on a ergometer bicycle by accumulation of exhaled air
Changes in isokinetic muscle strength
时间窗: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks
Changes in isokinetic muscle strength during resistance exercise. Four muscle groups bilateral are selected. CIDP: Knee flexion/extension Elbow flexion/extension MMN: Elbow flexion/extension Wrist flexion/extension
次要结局
- Change in Overall Disability Sum Score (ODSS)(-12, 0, 6, 12, 18, 24 weeks)
- Change in Medical Research Council (MRC)(-12, 0, 6, 12, 18, 24 weeks)
- Change in Quality of Life measured by The Short Form (36) Health Survey (SF-36) questionnaire(-12, 0, 6, 12, 18, 24 weeks)
- Change in 6-Minute Walk test(-12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks)
- Change in Fatigue Severity Score (FSS)(-12, 0, 6, 12, 18, 24 weeks)