Exercise-induced Muscle Soreness
Conditions
Keywords
Muscle, exercise, soreness, Damage, Traumeel, homeopathy
Brief summary
To investigate and compare the effects of Traumeel®S tablets versus placebo on recovery and inflammatory immune response over a period of 72 hours after a second bout of strenuous concentric exercise on bicycle (exercise #2).
Interventions
DRUGPlacebo
oral, Day 1: one tablet every 15 minutes for two hours after the exercise test, 6 hours and 10 hours after the exercise test; Day 2 and 3: two tablets thrice daily; Day 4: two tablets in the morning
DRUGTraumeel
oral, Day 1: one tablet every 15 minutes for two hours after the exercise test, 6 hours and 10 hours after the exercise test; Day 2 and 3: two tablets thrice daily; Day 4: two tablets in the morning
Sponsors
Biologische Heilmittel Heel GmbH
University of Giessen
Prof. Dr. med. Frank Christoph Mooren
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Sex: male * Age ≥ 18 and ≤ 40 years * BMI ≥ 18.5 and \< 27,5 kg/m2 (WHO standard for normal range BMI) * Maximum relative oxygen uptake (VO2max) \< 53 ml/kg x min * General state of good health * Non-smoker * Medically approved unrestricted participation in sports as shown by diagnostic performance test conducted on treadmill no longer than 3 months prior to study entry * Willingness to provide signed informed consent
Exclusion criteria
* Weekly training volume ≥ 6 hours * Use of dietary supplements (incl. high-dosed vitamins and minerals) * Chronic immune deficiency * Current infection * Heart and/or circulation disorders * Abnormal findings on exercise ECG * Musculoskeletal disorders * Any current clinical condition that requires systemic treatment or might have an impact on study objectives * Hypersensitivity to botanicals of the Compositae family (e.g. Echinacea) * Lactose intolerance * Illicit drug or alcohol abuse * Participation in another clinical trial within 4 weeks prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in post-exercise two baseline levels up to 72-hours of Interleukin-1 receptor antagonist (IL-1ra) | 72 hours |
| Changes in post-exercise two baseline levels up to 72-hours of Interleukin 6 (IL-6) | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Changes in post-exercise two baseline levels up to 72-hours of muscle damage markers (2 lab parameters) | 72 hours |
| Changes in post-exercise two baseline levels up to 72-hours of other immunomodulators (35 lab parameters) | 72 hours |
| Changes in post-exercise two baseline levels up to 72-hours Short Form McGill Questionnaire total scores and separate VAS pain ratings | 72-hours |
| Changes in post-exercise two baseline levels up to 72-hours of maximum isometric strength (separately for thigh flexors and extensors) | 72 hours |
| Changes in post-exercise two baseline levels up to 72-hours of immune status and activation markers (7 lab parameters) | 72 hours |
Countries
Germany
Outcome results
None listed