Effect of Physical Training in Individuals With Hypokalemic and Hyperkalemic Periodic Paralysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Functional endurance test in the form of the Five Times Sit-to-Stand Test (5STS)
研究概览
简要总结
This study wishes to investigate the effects of strength exercise in patients with either HypoPP or HyperPP.
The investigators wishes to include participants already diagnosed with either HypoPP or HyperPP in af 24 week prospective study where the patients will be tested and asked to fill out questionnaires three times. These appointments will be schedueled at week 0, week 12 and week 24.
In the time period between week 12 and week 24, the patients will have a personalized strength exercise program, which they will have to follow these 3 months. The exercise will be supervised by one or more of the investigators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with genetic verified HypoPP or HyperPP
- •Age minimum 18 years
- •Able to walk a minimum of 10 meters independently with or without assistive devices and be able to stand from a chair without using hands
排除标准
- •Other significant cause of muscle weakness
- •Heart or lung disease which, in the investigator's opinion, makes participation in the study training inadvisable
- •Exclusion from muscle biopsy
- •Anticoagulant treatment
- •Impaired blood clotting due to disease
- •Exclusion from MRI scanning due to:
- •Metal implants in the body that contraindicate MRI scanning or are positioned such that the scan quality is significantly affected
- •Claustrophobia
- •Pregnancy
结局指标
主要结局
Functional endurance test in the form of the Five Times Sit-to-Stand Test (5STS)
时间窗: From intervention to end of intervention at 12 weeks
次要结局
- Functional endurance test in the form of the 6-Minute Walk Test (6MWT)(12 weeks)
- Number of attacks of muscle weakness(12 weeks)
- Myotonia graded using the Myotonia Behaviour Scale (MBS)(12 weeks)
- Fatigue measured with the Multidimensional Fatigue Inventory (MFI-20)(12 weeks)
- Muscle strength measured with a dynamometer(12 weeks)
- Pain graded using the Visual Analog Scale (VAS)(12 weeks)
- Quality of life measured with the Individualized Neuromuscular Quality of Life Questionnaire (INQoL)(12 weeks)
- Quality of life measured with the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)(12 weeks)
研究者
Annica Buss Enegaard
BSc
Rigshospitalet, Denmark