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 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT04587895
Eligibility Criteria:
Inclusion Criteria:
Both (MI \& UI):
* Aged 60+ years
* Live independently, in a residency dwelling, or with care
* Standing straight for minimal 10 minutes without aids
* Visual acuity with correction sufficient to work on a TV screen
* Signed informed consent
Only MI:
\- SPPB \< 10 (only for the study group with MI)
Only UI:
* female
* diagnosed with mixed urinary incontinence (MUI) or urge urinary incontinence (UUI) according to the Questionnaire for Urinary Incontinence Diagnosis (QUID)
* moderate symptoms of UI (have reported at least 3 episodes of involuntary urine loss per week during the preceding 3 months)
* correct contraction of PFM must be possible
* must be able to undergo a gynaecological examination
Exclusion Criteria:
Both (MI \& UI):
* Mobility impairments that don't allow to play the exergame
* Heavy noticeable cognitive impairments according to Thomman et al.
* Acute or unstable chronic diseases (e.g., recent cardiac infarction, uncontrolled high blood pressure or cardiovascular disease, uncontrolled diabetes)
* Orthopedic or neurological diseases that inhibit exergame training
* Rapidly progressive or terminal illness
* Insufficient knowledge of German
* Chronic respiratory disease
* Condition or therapy that weakens the immune system
* Cancer
* Serious obesity (BMI \> 40kg/m2)
Only UI:
* Untreated chronic constipation
* Important pelvic organ prolapse
* Physiotherapy treatment or surgery for UI or pelvic organ prolapse in the past year
* Use of medications for UI or affecting skeletal muscles
* Change in hormonal replacement therapy in the last six months
* Having an active urinary or vaginal infection in the past three months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04587895
Study Brief:
Protocol Section:
NCT04587895