Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases

Completed

• Conditions: McArdle Disease; Limb-Girdle Muscular Dystrophy Type 2; Becker Muscular Dystrophy

• Registration Number: NCT04349566
• Lead Sponsor: Mads Peter Godtfeldt Stemmerik

Brief Summary

The purpose of the study is to explore the biomarker Fast Troponins response to exercise in patients with Becker muscular dystrophy, Limb-girdle muscular dystrophy and McArdle disease

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Study Start: 2020-06-01
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• The ability to cycle
• No concurrent medical condition that could interfere with interpretation of the results
• Molecular diagnosis of the specific condition in specified patient groups or healthy control
• No active muscle injury on the test day (caused by recent exercise, seizures, trauma, etc.)

Exclusion Criteria

• Competing conditions at risk of compromising the results of the study
• Cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise
• Veins that are too difficult to puncture for blood sampling, evaluated by the investigator
• Severe muscle weakness, that prevents the subject completing the exercise test, evaluated by the investigator

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in biomarkers	24 hours	Change in Fast and slow Troponin I after muscle damage

Trial Locations

Locations (1)

Neuromuscular Research Unit, 3342; 🇩🇰 Copenhagen, Denmark