CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 103 enrolled
Drug / intervention
Interval running protocol / eccentric-based resistance exercise protocolprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04458662
NCT04458662N/ACompleted

Iron and Muscular Damage: FEmale Metabolism and Menstrual Cycle During Exercise

Universidad Politecnica de Madrid·observational·Posted Jul 7, 2020·Updated Jul 7, 2020

In Brief

An observational study evaluating Interval running protocol / eccentric-based resistance exercise protocol for Iron-deficiency and 6 related conditions. Completed, enrolled 103 participants across 1 site.

Detailed Summary

This project is an observational controlled randomized counterbalance study. One hundred and three physically active and healthy women were selected to participate in the IronFEMME Study, of which 57 were eumenorrheic, 30 were oral contraceptive users (OCP) and 16 were postmenopausal women. The project consisted on two sections carrying out at the same time: Iron metabolism (Study I) and Muscle damage (Study II). For the study I, the exercise protocol consisted on an interval running test (8 bouts of 3 min at 85% of the maximal aerobic speed), whereas the study II protocol was based on an eccentric-based resistance exercise protocol (10 sets of 10 repetitions of plate-loaded barbell parallel back squats at 60% of their 1RM with 2 min of rest between sets). In both studies, eumenorrheic participants were evaluated at three specific moments of the menstrual cycle: Early-follicular phase, late-follicular phase and mid-luteal phase; OCP performed the trial at two moments: Withdrawal phase and active pill phase. Lastly, postmenopausal women were tested only once, since their hormonal status does not fluctuate. The three-step method was used to verify the menstrual cycle phase: calendar counting, blood analyses confirmation and urine-based ovulation kits. Blood samples were obtained to measure sexual hormones (e.g., 17β-Estradiol, Progesterone), iron metabolism parameters (e.g., Hepcidin, Iron, Ferritin, Transferrin) and muscle damage related markers (e.g., Creatine Kinase, Myoglobin, Lactate Dehydrogenase).

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 7, 2020
Enrollment StartJan 1, 2017
Primary CompletionMar 31, 2019
Study CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.0 years ago

Interventions

Interval running protocol / eccentric-based resistance exercise protocolprocedure