Repeated Bout Effect i Neuromuscular Diseases

The repeated bout effect (RBE) refers to the adaptation whereby a single bout of eccentric exercise protects against muscle damage from subsequent eccentric bouts. This effect has been shown in many muscle groups using both serum biomarkers, muscle soreness and imaging techniques. Though the effect is well described in healthy, it has never been studied in patients with neuromuscular diseases (NMDs).

In healthy, the RBE is only described using eccentric exercise, but unlike healthy persons, patients with NMDs can experience significant muscle damage with concentric exercise. This raises the question, if patients with NMDs could also show RBE when performing concentric exercise.

Study Overview

• Status: Recruiting
• Conditions: Myopathy
• Intervention / Treatment: Other: Exercise

Detailed Description

The repeated bout effect (RBE) refers to the adaptation whereby a single bout of eccentric exercise protects against muscle damage from subsequent eccentric bouts. This effect has been shown in many muscle groups using both serum biomarkers, muscle soreness and imaging techniques. Though the effect is well described in healthy, it has never been studied in patients with neuromuscular diseases (NMDs).

NMDs are a common term for diseases that affect the muscles by disease processes in the motor neuron, peripheral nerve, neuromuscular junction or the muscles. The diseases can cause symptoms such as muscle weakness, muscle fatigue and sometimes muscle pain and varying degrees of physical disability. As the mechanisms for disease varies among NMDs, it is likely that some patients will experience RBE in a similar fashion to healthy, while others may not.

Recent years have shown significant breakthrough in the treatment development for various NMDs, and many of these treatments are currently or will soon be evaluated in clinical trials. As many trials will use exercise to evaluate treatment effect, it is vital to understand whether a single bout of exercise in itself provides a protective effect on the muscles of patients with NMDs.

In healthy, the RBE is only described using eccentric exercise, but unlike healthy persons, patients with NMDs can experience significant muscle damage with concentric exercise. This raises the question, if patients with NMDs could also show RBE when performing concentric exercise.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mads Stemmerik, MD; Phone Number: +4535456126; Email: mads.peter.godtfeldt.stemmerik@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2100
    • Recruiting
    • Neuromuscular Research Unit, 3342

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18 years
• The ability to complete the exercise challenge
• 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:

• Cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise defined as NYHA-class III-IV
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Exercise challenge; At baseline, subjects will perform the selected exercise challenge followed by blood samples collected at rest and 0, 2, 4, 24 hours and 4 days after end of exercise. Muscle soreness will be measured by asking the participant how sore their muscles in their thighs are on a visual-analog scale (1-10) at the same timepoints. After 4 weeks (+/- 3 days) of normal daily activity, the same test will be performed including blood samples.

Other: Exercise; Either concentric or excentric exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta CK	Change in peak kreatine kinase following first and second exercise bout.	1 month

Collaborators and Investigators

• Sponsor: Mads Peter Godtfeldt Stemmerik

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: P-2022-168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No