Angelica Lindén Hirschberg
Stockholm, 17176, Sweden
Location status: Recruiting
Location contact
Angelica L Hirschberg, Professor
CONTACT
Cecilia Fridén, Ass Prof
CONTACT
NCT Number: NCT05697263
The menstrual cycle implies a basic difference in the biology of women and men but the effect of the hormonal variation on training protocols and physical performance is still not fully understood. Despite no existing evidence, the advice to periodize exercise according to the menstrual cycle has been widely spread among elite athletes, coaches, and sports federations. The advice is based on underpowered studies with considerable methodological weaknesses regarding determination of cycle phase, inclusion of athletes and lack of adequate control groups.
The purpose of this randomized, controlled study is to evaluate the effect of exercise periodization on aerobic fitness during different phases of the menstrual cycle. Further, the effect will be related to premenstrual symptoms, body composition and skeletal muscle morphology, sex hormone receptors, metabolic enzymes, and markers of muscle protein synthesis. This study will be well controlled and follow methodology recommendations for menstrual cycle research in sports and exercise.
Female athletes of fertile age will be randomized to different training regimens during three menstrual cycles (12 weeks):
Group A: Training three times a week throughout the menstrual cycle. Group B: Follicular phase-based training five times a week during the follicular phase and thereafter once a week during the luteal phase.
Group C: Luteal phase-based training five times a week during the luteal phase and once a week in the follicular phase.
The exercise will consist of high intensity intermittent spinning classes. Assessment of aerobic fitness and power will be performed at baseline, and again after three completed menstrual cycles. On the same day, body composition will be examined by DXA and blood samples will be collected for analysis of hormones and binding proteins. To confirm menstrual cycle phase, blood samples will be collected for hormone determination, and urinary stick will be used for detection of ovulation. Subjective ratings of menstrual cycle related symptoms will be performed every day. In a subgroup of women, muscle biopsies will be collected from m vastus lateralis at baseline and at the end of the study. This study will contribute to improved knowledge about exercise periodization in relation to the menstrual cycle. Well-grounded data is crucial to give evidence-based recommendations to female athletes when planning their training protocol to optimize training results and performance.
Interested in participating?
Request Info18 year–35 year
Female
Interventional
Not applicable
Stockholm, 17176, Sweden
Location status: Recruiting
Angelica L Hirschberg, Professor
CONTACT
Cecilia Fridén, Ass Prof
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in the three arms will exercise the same dose and number of sessions distributed in three different ways.
Time frame: Change from baseline aerobic performance at the end of Cycle 4 (each cycle is around 28 days)
Cosmeds K5 Wearable Metabolic System will be used for breath-by-breath gas exchange measurements. Change in VO2peak from baseline to end of study will be evaluated.
Time frame: Change from baseline muscle strength at the end of Cycle 4 (each cycle is around 28 days)
A standardized isokinetic device (Biodex®, Corp, Shirley, NY, USA) will be used for measurements of maximal muscle torque (Nm) in the leg extensor muscles at 90 and 120 gr/sec (11). Change in muscle strength from baseline to end of study will be compared between groups.
Time frame: Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)
Assessment of functional muscle strength in the lower extremities.
Time frame: Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)
Assessment of functional muscle strength in the lower extremities.
Time frame: Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)
Differences in body fat (%) will be determined by DXA (Lunar equipment).
Time frame: Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)
Differences in muscle mass (g), will be determined by DXA (Lunar equipment).
Time frame: Every day during the study period
Prospective ratings of premenstrual symptoms will be performed with the Cyclicity Diagnoser
Time frame: Change from baseline metabolic serum markers at the end of Cycle 4 (each cycle is around 28 days)
Blood samples for analysis of IGF-1.
Time frame: Change from baseline muscle morphology at the end of Cycle 4 (each cycle is around 28 days)
Muscle biopsy in mm vastus lateralis
Time frame: Change from baseline muscle tissue steroid hormones at the end of Cycle 4 (each cycle is around 28 days)
Muscle biopsy in mm vastus lateralis
Time frame: Change from baseline muscle protein synthesis at the end of Cycle 4 (each cycle is around 28 days)
Muscle biopsy in mm vastus lateralis
Time frame: Through study completion, an average of 4 month
Questionnaire
Time frame: Through study completion, an average of 4 months
Blood sampels will be collected at early follicular phase, ovulation phase and mid luteal phase for analysis of LH, FSH, estradiol and progesterone.
Contact information is provided by the study sponsor or research team.
Angelica L Hirschberg, Med dr
CONTACT
Cecilia Fridén, Med dr
CONTACT
Karolinska Institutet
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06377306
Athletes, Behavior
Netanya, Israel
View Trial DetailsNCT07699224
Abnormal Uterine Bleeding (AUB), Dysmenorrhea
Madrid, Spain
View Trial DetailsNCT07456202
Menstrual Cycle, Nausea
Ankara, Turkey (Türkiye)
View Trial DetailsNCT07591818
Athlete, Menstrual Cycle
Cruz Quebrada, Oeiras, Portugal
View Trial Details