Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

Not Applicable

Completed

• Conditions: Myositis, Juvenile
• Interventions: Dietary Supplement: glucose tablet; Dietary Supplement: creatine monohydrate; Dietary Supplement: gel capsule; Dietary Supplement: ubiquinol; Behavioral: Exercise

• Registration Number: NCT04286178
• Lead Sponsor: The Hospital for Sick Children

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 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 JDM 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-26
• Study Start: 2021-04-06
• Status Verified: 2024-03
• Primary Completion: 2024-03-05
• Study Completion: 2024-03-05
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment	Exercise	patients in this arm will be treated with creatine and coenzyme Q10 supplements
Placebo	Exercise	patients in this arm will be given placebo supplements that look and taste identical to the active supplements
Placebo	glucose tablet	patients in this arm will be given placebo supplements that look and taste identical to the active supplements
Placebo	gel capsule	patients in this arm will be given placebo supplements that look and taste identical to the active supplements
Treatment	creatine monohydrate	patients in this arm will be treated with creatine and coenzyme Q10 supplements
Treatment	ubiquinol	patients in this arm will be treated with creatine and coenzyme Q10 supplements

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 physical function	6 months	Change in physical function will be determined by the change in the vertical jump achieved, measured in centimeters

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada