Status:
COMPLETED
Exercise, Creatine and Coenzyme Q10 for Childhood Myositis
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Myositis, Juvenile
Eligibility:
All Genders
7-18 years
Phase:
NA
Brief Summary
Children with JDM are weak and get tired because their muscles aren't able to work like healthy muscles. This can make it hard for them to do normal everyday things and can make them less happy about ...
Eligibility Criteria
Inclusion
- Ages 7 to 18 years
- Diagnosis of juvenile idiopathic inflammatory myopathy (JIIM) according to the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria: ≥90% probability, age of onset \<18 years
- Subjects on a stable course of medication (unlikely to change over study treatment period as determined by treating physician)
- Minimum height of 132.5cm (required to fit on the cycle ergometer)
Exclusion
- Subjects with newly diagnosed JIIM within the previous 6 months
- Subjects unable to cooperate with study procedures, or too weak to participate in the exercise testing
- Subjects with impaired kidney function as determined from pre-baseline visit screening lab values (eGFR \<90 ml/min/1.73m\^2)
- Subjects currently taking anti-hypertensive drugs or blood thinners
- Subjects who are currently pregnant or planning to become pregnant within the study period
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04286178
Start Date
April 6 2021
End Date
March 5 2024
Last Update
March 22 2024
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8