Repeated Bout Effect i Neuromuscular Diseases

Sponsor
Mads Peter Godtfeldt Stemmerik (Other)
Overall Status
Recruiting
CT.gov ID
NCT05599568
Collaborator
(none)
50
1
1
24.5
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Repeated Bout Effect i Neuromuscular Diseases
Actual Study Start Date :
May 15, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Delta CK [1 month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neuromuscular Research Unit, 3342 Copenhagen Denmark DK-2100

Sponsors and Collaborators

  • Mads Peter Godtfeldt Stemmerik

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mads Peter Godtfeldt Stemmerik, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT05599568
Other Study ID Numbers:
  • P-2022-168
First Posted:
Oct 31, 2022
Last Update Posted:
Oct 31, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2022