Long COVID Fatigue
Conditions
Keywords
creatine, post-exertional malaise, exercise, nutraceutical
Brief summary
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
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTCreatine monohydrate
8 g/day creatine monohydrate powder
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized 1:1 to the treatment or control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen consumption at ventilatory threshold | 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 | From enrollment to the end of intervention at 8 weeks | heart rate (in bpm) at point of ventilatory threshold |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | From baseline to mid intervention (4 weeks) to the end of the intervention (8 weeks) | severity assessed using visual analog scale with zero being not present and 100 being the worst imaginable |
| Brain fog | From baseline to mid intervention (4 weeks) to post intervention (8 weeks) | severity assessed using visual analog scale with zero being not present and 100 being the worst imaginable |
Contacts
Primary ContactKeely A Shaw, PhD
Outcome results
None listed