Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

NCT04286178 — Not applicable, Completed, 15 participants, The Hospital for Sick Children

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The Effects of Exercise, Creatine, and Coenzyme Q10 Supplementation on Muscle Function in Children With Myositis

Registry	NCT04286178
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: quadruple, supportive care
Enrollment	15 (Actual)
Sponsor	The Hospital for Sick Children (Other)
Conditions	Myositis, Juvenile
Interventions	creatine monohydrate, ubiquinol, glucose tablet, gel capsule, Exercise (Dietary supplement, behavioral)
Dates	start 2021-04-06, primary completion 2024-03-05, completion 2024-03-05, first posted 2020-02-26, last updated 2026-04-28
Locations	1 site in Canada

-Summary

Children with Juvenile Idiopathic Inflammatory Myopathies (JIIM) 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 their lives compared to children without the disease. There are two nutritional supplements that help muscles use energy and recover after exercise: creatine and coenzyme Q10. If the muscle has more energy, it may not be as weak and may not feel as tired or sore after exercise. Because of this we want to see if having children with JIIM take creatine and coenzyme Q10 can make them stronger and less tired. If this works, we hope it will let them be able to do the things that healthy children can do, and make them feel better about their lives.

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+Arms and interventions

Arm	Type	Interventions	Description
Treatment	Experimental	Dietary Supplement: creatine monohydrate; Dietary Supplement: ubiquinol; Behavioral: Exercise	patients in this arm will be treated with creatine and coenzyme Q10 supplements
Placebo	Placebo comparator	Dietary Supplement: glucose tablet; Dietary Supplement: gel capsule; Behavioral: Exercise	patients in this arm will be given placebo supplements that look and taste identical to the active supplements

creatine monohydrate (Dietary supplement): Creatine will be taken at a dose of 150mg/kg/day of creatine base divided into 2 daily doses up to 39.7kg in body weight, after which dosing will be based on body surface area (BSA) at 4.69g/m2/day. Creatine will be administered orally as a chewable tablet provided by BioTechUSA™. Tablets are 2g and contain 0.9g of creatine monohydrate which is equivalent to 0.8g of creatine base.
ubiquinol (Dietary supplement), also known as coenzyme Q10: Coenzyme Q10 (CoQ10, ubiquinol) will be taken at a dose of 10mg/kg/day divided into 2 daily doses with a daily maximum of 500mg. CoQ10 will be administered orally in 50mg softgels containing 50mg of ubiquinol (Active Q®), provided by Tishcon Corporation.
glucose tablet (Dietary supplement): Creatine placebo will be in the form of a glucose tablet with identical appearance and taste to the active supplement. The number of tablets/day will be determined based on the dose of creatine required for each patient.
gel capsule (Dietary supplement): Ubiquinol placebo will be in the form of a gel capsule with identical appearance to the active supplement. The number of capsules/day will be determined based on the dose of ubiquinol required for each patient.
Exercise (Behavioral): Participants will be coached to hit 12,000 steps or 60 "active minutes" per day as logged by a FitBit (FitBit calculates active minutes as activities equivalent to moderate-to-vigorous physical activity (MVPA) done continuously for at least 10 minutes)

+Outcome measures

Primary outcomes

Change in muscle function [6 months]: Change in muscle function will be determined by the change in peak power achieved on the wingate anaerobic cycling test between the active supplement phase and the placebo phase

Secondary outcomes

Change in muscle fatigue [6 months]: Change in muscle fatigue will be determined by the change in the fatigue index during the wingate test. Fatigue index is a percentage, and is calculated as follows: \[(Peak Power - End Power)/Peak Power\] x100
Change in general fatigue [6 months]: Change in fatigue will be determined by the change in the Pediatric Quality of Life - Fatigue Module scores (PedsQL-Fatigue). This measure is scored on a scale of 0-100 with 100 representing the least amount of fatigue.
Change in quality of life [6 months]: Change in quality of life will be determined by the change in the Quality of My Life questionnaire scores. Quality of my Life consists of 3 visual analog scales each scored out of 10. Higher scores indicate better quality of life.
Change in physical function [6 months]: Change in physical function will be determined by the change in the hand grip strength, measured using a hand dynamometer. Three attempts will be given per hand, and the maximum grip strength achieved (in kg displaced) will be recorded for each hand.
Change in physical function [6 months]: Change in physical function will be determined by the change in the vertical jump achieved, measured in centimeters

+Eligibility

Sex: All, ages: 7 Years to 18 Years

Inclusion Criteria:

* 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 Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
The Hospital for Sick Children	Toronto, Ontario	Canada

+Investigators

Brian Feldman, MD, MSc, Principal investigator, The Hospital for Sick Children