Effect of Supplementation With Creatine on the Early Recovery of Ischemic Stroke: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Physical performance
研究概览
简要总结
Stroke is a leading cause of disability and the second leading cause of death worldwide. Most strokes are ischemic, caused by acute arterial occlusion. Post-stroke treatment focuses on secondary prevention and rehabilitation, but few treatments address functional recovery. Creatine, a supplement known for improving physical performance, may aid in the recovery of stroke patients, reducing sarcopenia and improving strength among other effects. This pilot study will investigate the effectiveness of creatine supplementation in enhancing physical and functional recovery in ischemic stroke patients. The study will involve a randomized, double-blind clinical trial comparing creatine monohydrate to a placebo.
详细描述
Stroke is one of the most impactful health conditions worldwide, currently being the leading cause of disability and the second leading cause of death globally. Approximately 85-90% of strokes are ischemic, primarily caused by acute arterial occlusion, leading to an area of cerebral, spinal, or retinal infarction. The size of the lesion depends on the affected blood vessel and the duration of the occlusion, as well as cerebral autoregulation, blood pressure, blood sugar levels, and many other factors. After the acute phase, treatment is based on secondary prevention and rehabilitation, with few treatments currently available that focus on functional recovery once the infarction has occurred. Stroke survivors experience a loss of functionality, a decline in physical capacity associated with a decrease in muscle mass, sarcopenia, cognitive impairment, and an increase in anxiety and depressive symptoms.
Creatine is a widely studied nutritional supplement, mainly in athletes, where it has been shown to improve training adaptation and physical performance. Its effects on energy metabolism, as an anti-inflammatory, and on calcium homeostasis have been described. There are also studies indicating possible musculoskeletal benefits in the elderly population. Given its role in improving physical performance and muscle mass, considering the significant impact of these conditions on patients who have suffered an ischemic stroke, and considering its antioxidant and anti-inflammatory effects, we propose a pilot study to determine the effectiveness of creatine supplementation in stroke patients. This supplementation could potentially lead to greater physical and functional recovery following an ischemic stroke.
A randomized, double-blind clinical trial will be conducted. The trial will include a group supplemented with creatine monohydrate at a dose of 0.3 g/kg/day for 7 days, followed by 0.1 g/kg/day for 12 weeks, alongside standard clinical practice; and a control group supplemented with a placebo (corn starch maltodextrin), following the same protocol and doses.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A professional from the pharmacy service, who will not be involved in data collection or participant care, will handle the blinding.
The care staff responsible for patient care will be unaware of each participant's assignment group.
Blinding may be broken if a serious adverse effect related to the supplementation is suspected in one of the participants.
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 between 18 and 80 years
- •Recent diagnosis of ischemic stroke (from 24 hours to 5 days) .
- •Neurological deficit due to the stroke that affects mobility (paresis and/or ataxia) and requires motor rehabilitation.
- •Ability to understand and sign the informed consent form, or failing that, have sufficient support to carry out the correct follow-up of the study.
排除标准
- •Moderate-severe disability prior to stroke, defined by an mRS>
- •Unstable or severe clinical situation that prevents active rehabilitation.
- •Neurological deficit due to stroke that prevents walking without help from another person. The use of support with a cane, crutch or walker is permitted.
- •Moderate or severe dysphagia that makes therapeutic adherence difficult.
- •Use of creatine supplements in the last 3 months, or use of anabolic products in the last 3 months.
- •Severe kidney disease (GFR <30ml/min/1.73 m2).
- •Musculoskeletal pathology that prevents assessment of muscle strength. For example: fractures, severe osteoarthritis, ligament tears or tendinopathies.
- •History of allergic reactions to creatine.
- •Pregnancy or breastfeeding.
- •Simultaneous participation in another clinical trial.
结局指标
主要结局
Physical performance
时间窗: 3 months, 6 months
To analyze the improvement in physical performance, at 3 months (at the end of the intervention) and at 6 months, measured by the 6-Minute Walking Test (6MW).
次要结局
- Physical performance using Test "timed up and go" (TUG).(3 months, 6 months)
- Maximum muscle strength(3 months, 6 months)
- Arm and leg muscle strength(3 months, 6 months)
- Balance and stability(3 months, 6 months)
- Functional impact(3 months, 6 months)
- Performance in basic activities of daily living(3 and 6 months)
- Cognitive assessment(3 months)
- Quality of life measured by EuroQol 5D(3 months, 6 months)
- Anxiety and depression symptoms(3 months)
- Appendicular skeletal muscle mass(3 months)
- Total skeletal muscle mass(3 months)
- Appendicular body fat(3 months)
- Total body fat(3 months)
- Nutritional status(3 months, 6 months)
- Number of falls.(3 months, 6 months)
- Geriatric Nutritional Risk Index (GNRI) score(3 months, 6 months)
- Ventricular strain change(3 months)
- Ejection fraction change(3 months)
- Adverse events(From enrollment to the end of treatment at 6 months)