Repeated Bout Effect i Neuromuscular Diseases

NCT05599568 | Recruiting

• 1 other identifier: P-2022-168
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopathy

Outcome Measures

Primary Outcomes (1)

• Delta CK

  Change in peak kreatine kinase following first and second exercise bout.

  1 month

Study Arms (1)

Exercise challenge

OTHER

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

Interventions

Exercise OTHER

Either concentric or excentric exercise

Exercise challenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mads Peter Godtfeldt Stemmerik: lead

Study Sites (1)

Neuromuscular Research Unit, 3342

Copenhagen, DK-2100, Denmark

RECRUITING

MeSH Terms

Conditions

Muscular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Mads Stemmerik, MD

CONTACT

+4535456126; mads.peter.godtfeldt.stemmerik@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Subinvestigator

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: May 15, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

DK (1)