Physical Activity Clinical Trial
Official title:
Identifying Periods of High Training Load Considering the Menstrual Cycle Phases in Elite and Non-elite Female Athletes Using Measures of Strength, Fatigue, Injury, Psychological Parameters, Serum Circulating Metabolites and the Intestinal Microbiome
NCT number | NCT06377306 |
Other study ID # | MC study |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 5, 2023 |
Est. completion date | January 30, 2027 |
Despite a rise in the number of women participating in competitive sports, there remains a gender gap within sport and exercise science literature. Studying females involves potential "noise" through the change in hormone concentrations during the different phases of the female menstrual cycle (MC) which can potentially affect physiological parameters, thereby making study design and interpretation of findings difficult. Longitudinal data on the acute and chronic combined effects of training load and MC phases on circulating female hormones in elite and non-elite female athletes is lacking. The investigators aim to characterize and track the potential effects of training load and MC phases on performance, anthropometric measures, sport emotions, intestinal microbiome, serum metabolites and injury prevalence in elite and non-elite female athletes. 200 competitive premenopausal female athletes will be recruited. In a longitudinal observational design, each participant will be followed for 1 year, and tested at three time points. At each point, data will be collected on two occasions reflecting distinct phases of the MC. Finding the possible relationship between the MC phases, training load and performance or specific bio-markers for training load are of utmost importance and can assist professionals to identify periods of high load and over-training, thus preventing injuries and training adjustment.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 30, 2027 |
Est. primary completion date | January 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Elite athletes are defined as participating and competing at national and/or international level at their sports. - Non-elite athletes are defined as performing at least 3 hours of physical activity per week. Exclusion Criteria: - Currently pregnant or lactating or planning a pregnancy in the following year. - Regular drug use which may affect performance, including but not limited to performance enhancing drugs. - Any medical diagnosis, including recent or current injury, which could affect performance and/or health under the discretion of the study team. |
Country | Name | City | State |
---|---|---|---|
Israel | Wingate Institute | Netanya |
Lead Sponsor | Collaborator |
---|---|
Wingate Institute | Kaplan Medical Center, Ministry of Innovation, Science and Technology of Israel, Weizmann Institute of Science |
Israel,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Psychological questionnaire (The Sport Emotion Questionnaire (SEQ) | The Sport Emotion Questionnaire (SEQ) is a sport-specific measure of precompetitive emotion grounded in the experience of athletes, assessing: anger, anxiety, dejection, excitement, and happiness. The SEQ shows good evidence of validity and reliability and represents a range of emotions with greater emphasis on positive emotions than that provided by other available group-oriented measures for use in sport research. The participants will be asked to rate themselves on a five-point Likert scale. | 3-6 times during 12 months | |
Primary | Stool Microbiome | Participants will receive kits in order to collect stool samples at home, and store it in their home freezers until they will be delivered to the Elinav lab at the Weizmann Institute, where they will be stored encoded at -80C. A whole-genome shotgun metagenomics sequencing will be performed on the samples. This will enable the investigators to sample all genes in all organisms present in each sample, including unknown unculturable bacteria. | 3-6 times during 12 months | |
Primary | Serum metabolomics | An untargeted high-performance liquid-chromatography mass-spectrometry is used to characterize the small molecules profile in plasma samples? | 3-6 times during 12 months | |
Primary | VO2max | Maximal Aerobic power | 3-6 times during 12 months | |
Primary | Countermovement jump | Countermovement jump performance will be measured using the Optojump Next system. The participants will be instructed to start from an upright position and to descend to a self-selected depth by bending at the hips and knees, immediately followed by a maximal vertical jump effort. Participants' hands will be kept on their hips throughout the entire movement. Participants will perform three attempts, separated by 30 seconds rest. Jump height will be recorded to the nearest 0.1 cm. The best and calculation of average jumps' height will be selected for statistical analysis. | 3-6 times during 12 months | |
Primary | Flexibility | Sit and reach and ankle dorsiflexion range of motion | 3-6 times during 12 months | |
Primary | Grip Strength | Maximal voluntary isometric hand grip | 3-6 times during 12 months | |
Primary | Lower leg Strength | Isokinetic strength during Knee extension and flexion | 3-6 times during 12 months | |
Primary | Blood tests | Blood tests will draw in the morning in a fasted state. The following parameters will be evaluated from the plasma: TSH (mlU/l), FT4 (pmol/l), FT3 (pmol/l), GH (ng/ml), IGF-1 (nmol/l), Testosterone total (nmol/l), Testo free (nmol/l), SHBG (nmol/l), Insulin (mU/l), 25OHD (nmol/l), Albumin (g/dl), Cortisol (nmol/l), Glucose (mg/dl) | 3-6 times during 12 months | |
Primary | Knee valgus | This test assesses dynamic knee valgus during a double leg drop jump using the reliable method of calculating the frontal plane projection angle. The athlete will perform a drop jump from a 30cm box landing with each foot on a force plate then immediately exploding upwards into a vertical jump. The athlete will be videoed using a video camera placed directly in front of the subject, 5m away. Markers will be placed by an experienced clinician on the midpoint of the femoral condyles, midpoint of the ankle malleoli, and proximal thigh along a line from the ASIS to the knee marker. The angle between line from the proximal thigh to the knee joint and line from the knee joint to the ankle at maximum knee flexion. Knee valgus = positive angle; Knee varus = negative angle. Reactive strength index will be calculated from force plate data providing information on plyometric performance, reactive jump capacity and dynamic explosive ability. The athlete will perform two drop jumps. | 3-6 times during 12 months | |
Secondary | Anthropometric (Height) | Height in centimeters | 3-6 times during 12 months | |
Secondary | Psychological questionnaire (Positive-Affect Negative-Affect scale - PANAS) | Two primary general dimensions of mood, positive and negative affect, will be measured by using the Positive-Affect Negative-Affect Scale. The 20-items scale is internally consistent and has excellent convergent and discriminant correlations with lengthier measures of the same underlying mood factors. The participants will be asked to rate themselves on a five-point Likert scale. | 3-6 times during 12 months | |
Secondary | Anthropometric (Weight) | Body mass in kg | 3-6 times during 12 months | |
Secondary | Percentage body fat (%) | Body fat will assessed using Dexa | 3-6 times during 12 months |
Status | Clinical Trial | Phase | |
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