Exploring Creatine Supplementation for Improved Exercise Capacity and Reduced Fatigue in Long COVID-19: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Oxygen consumption at ventilatory threshold
研究概览
简要总结
Individuals living with Long COVID often experiencing a degree of undue fatigue after physical or cognitive exertion secondary to the condition, timed post-exertional malaise 9PEM). This trial aims to explore the efficacy of creatine monohydrate in managing PEM
详细描述
cognitive dysfunction, and post-exertional malaise are common complaints of those living with Post-COVID Condition (PCC), a sequelae of symptoms that persist beyond acute infection. Similar to other types of post-viral fatigue, the diagnosis and treatment of PCC are challenging due to the lack of a valid biomarker for the condition. Though the etiology of PCC is not well understood, recent research has found reduced skeletal muscle creatine concentration in those with PCC, which may contribute to fatigue. The objective of this study is to determine if eight weeks of creatine monohydrate supplementation (8g/day) improves symptoms of fatigue, cognition, exercise capacity, and PEM in individuals living with PCC.
Participants will complete two cardiopulmonary exercise tests 24-hours apart on a cycle ergometer before and after an eight-week intervention period. Venous blood samples will be collected before and after exercise on both days to assess changes in mitochondrial function. During the intervention, participants will be randomly assigned to supplement with 8g/day of either creatine monohydrate or a control (maltodextrin). Cognition will be indirectly assessed via self-report of cognitive symptom frequency and severity at baseline, mid-intervention (i.e., 4 weeks) and post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experiencing symptoms at least 3 months after a COVID-19 diagnosis confirmed by positive polymerase chain reaction (PCR) test
- •Experiencing post-exertional malaise, as per the DePaul Symptom Questionnaire
排除标准
- •Allergy or intolerance to creatine monohydrate or maltodextrin
- •Supplemented with creatine in the past eight weeks
- •orthopaedic injury or condition that would prevent exercise testing
- •change in medication related to Long COVID symptom management in the past month.
研究组 & 干预措施
Creatine monohydrate
8 g/day creatine monohydrate
干预措施: Creatine monohydrate (Dietary Supplement)
Maltodextrin
8 g/day maltodextrin
干预措施: Creatine monohydrate (Dietary Supplement)
结局指标
主要结局
Oxygen consumption at ventilatory threshold
时间窗: From enrollment to the end of intervention at 8 weeks
point of respiratory compensation point (i.e., ventilatory threshold 2) as a percent of maximal oxygen consumption
Heart rate at ventilatory threshold
时间窗: From enrollment to the end of intervention at 8 weeks
heart rate (in bpm) at point of ventilatory threshold
次要结局
- Fatigue(From baseline to mid intervention (4 weeks) to the end of the intervention (8 weeks))
- Brain fog(From baseline to mid intervention (4 weeks) to post intervention (8 weeks))
研究者
Keely Shaw
Postdoctoral Associate
University of Calgary