Recruiting NCT05599568

Repeated Bout Effect i Neuromuscular Diseases

No phase Interventional Myopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Exercise.
Who it may be relevant to: Registry conditions: Myopathy. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Denmark
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

Other Exercise
Either concentric or excentric exercise

Primary outcome measures

Delta CK [Time frame: 1 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Basic science

Study locations

Denmark · 1 center

Neuromuscular Research Unit, 3342 — Copenhagen

Identifiers

NCT: NCT05599568 · P-2022-168

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗