Actively Recruiting
Repeated Bout Effect in Neuromuscular Diseases
Led by Mads Peter Godtfeldt Stemmerik · Updated on 2025-04-06
50
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the repeated bout effect (RBE), an adaptation where one session of eccentric exercise reduces muscle damage from later sessions, in people with neuromuscular diseases (NMDs). While RBE is well documented in healthy individuals, its presence in patients with NMDs has not been studied. These diseases affect muscles through various mechanisms causing weakness, fatigue, and sometimes pain, and responses to exercise may differ from healthy people. Participants will perform either concentric or eccentric exercise challenges. At baseline, blood samples and muscle soreness ratings will be collected before and at several points after exercise, including immediately, 2, 4, 24 hours, and 4 days later. After about four weeks of normal activity, the same exercise and measurements will be repeated to evaluate any protective effect from the initial bout. During the study, participants will report their muscle soreness on a scale from 1 to 10 and provide blood samples at specified times. Researchers will measure changes in creatine kinase levels as a primary outcome to assess muscle damage. The study will monitor participants before and after exercise sessions to understand how muscle damage and soreness evolve and whether repeated exercise offers protection in NMD patients.
CONDITIONS
Brief Title
Repeated Bout Effect i Neuromuscular Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Ability to complete the exercise challenge
- No concurrent medical condition that could interfere with interpretation of the results
- Molecular diagnosis of the specific neuromuscular condition or healthy control
- No active muscle injury on the test day from recent exercise, seizures, trauma, or similar causes
You will not qualify if you...
- Cardiac or pulmonary disease that contraindicates peak or strenuous exercise (NYHA-class III-IV)
- Difficulty in blood sampling due to problematic veins as evaluated by the investigator
- Severe muscle weakness preventing completion of the exercise test as evaluated by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day with follow-up assessments over 4 days
Participants perform an exercise challenge followed by multiple blood samples and muscle soreness assessments over several days.
1 exercise visit with blood samples and soreness assessments at rest, 0, 2, 4, 24 hours, and 4 days post-exercise
Duration - 4 weeks (+/- 3 days)
Participants maintain normal daily activity without intervention for approximately 4 weeks.
No visits during this period
Duration - 1 day with follow-up assessments over 4 days
Participants repeat the same exercise challenge with the same schedule of blood samples and muscle soreness assessments as the initial challenge.
1 exercise visit with blood samples and soreness assessments at rest, 0, 2, 4, 24 hours, and 4 days post-exercise
Trial Site Locations
Total: 1 location
1
Neuromuscular Research Unit, 3342
Copenhagen, Denmark, DK-2100
Actively Recruiting
Research Team
M
Mads Stemmerik, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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