Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT04332757
Eligibility Criteria:
Inclusion Criteria:
1. Serving, pregnant (third trimester) or 0 to 6 weeks postpartum UK MOD Servicewomen.
2. ≥ 18 years old.
3. Free from any condition or injury that may affect the individual's ability to perform exercise (health screen).
4. Passed fit to exercise by their GP at their routine 6-week postnatal check-up
5. Passed fit to participate by a specialist women's health physiotherapist using study specific assessment criteria.
6. Consent to be pregnancy tested before scans at 6 and 24 weeks postpartum.
Exclusion Criteria:
1. \< 18 years old
2. Diagnosed with post-natal depression or another mental health condition requiring specialist psychiatric secondary care. Additionally, any participant who is found to have, or develops over the course of the trial, severe post-natal depression or suicidal tendencies, will be referred back to their GP.
3. Injured or suffering from another condition that can affect the individual's ability to perform exercise.
4. Not passed fit to exercise by their GP at their routine 6-week postnatal check \[using standard fitness assessment criteria\].
5. Not passed fit to participate following the women's clinical health assessment \[using study specific assessment criteria\].
6. Women who report that they could be pregnant and / or have a positive pregnancy test before measurements at 6 and 24 weeks postpartum will not be scanned using DXA or HR-pQCT. They will cease to take any further part in the trial and will be advised to visit their GP.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04332757
Study Brief:
Protocol Section:
NCT04332757