Multidisciplinary intervention to reduce fall risk and urinary incontinence in older women
Effects of a Multidisciplinary Intervention on Fall Risk and Urinary Incontinence in Older Women
NA · Fundación Universidad Católica de Valencia San Vicente Mártir · NCT06839040
This study is testing if a combination of exercise, physical therapy, and education can help older women reduce their risk of falling and manage urinary incontinence.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | Female |
| Sponsor | Fundación Universidad Católica de Valencia San Vicente Mártir (other) |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT06839040 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a multidisciplinary intervention that includes physiotherapy, physical exercise, and psychoeducation on fall risk and urinary incontinence in older women aged 60 to 80 years. Participants will be randomly assigned to one of four groups: two exercise groups with different levels of verbal instruction, one exercise group without verbal instructions, and a control group. The intervention will last for 18 weeks, with exercise sessions conducted twice a week and psychoeducation sessions held five times throughout the program. The study aims to provide insights into the combined effects of these therapies on improving health outcomes for older women.
Who should consider this trial
Good fit: Ideal candidates for this study are non-institutionalized women aged 60 to 80 years who have been diagnosed with urinary incontinence and have not engaged in physical exercise for the past three months.
Not a fit: Patients with severe cognitive impairments, significant medical conditions, or those who have recently engaged in physical exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce fall risk and urinary incontinence in older women, enhancing their quality of life.
How similar studies have performed: While there is limited evidence on the combined effects of physical exercise and psychoeducation for these conditions, previous studies have shown positive outcomes for each intervention separately.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Woman, aged between 60 and 80 years. * Not having done physical exercise in the last 3 months. * Present UI (SUI, UUI or MUI) after clinical diagnosis. * Score greater than 90 on the Barthel Scale. * Not present pathologies or functional alterations that limit the practice of physical exercise. * Not present severe cognitive alterations or mild cognitive deficit (Global Deterioration Scale less than or equal to 2 or Mini Mental State Examination greater than or equal to 25 points). * Maintain walking without support products. * Carry out 80% of the total sessions Exclusion Criteria: * Intake of medication that could affect the performance of the exercise or alter the variables studied. * Present grade II-IV uterine prolapses. * Clinical disease or syndrome (chronic or acute cardiovascular, neurological, respiratory or musculoskeletal disorders) that may interfere with the performance of the intervention and evaluation. * Present visual and/or auditory alterations that make it difficult to carry out the intervention and evaluation.
Where this trial is running
Valencia, Valencia
- Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of ValenciaSan Vicente Mártir) — Valencia, Valencia, Spain (RECRUITING)
Study contacts
- Principal investigator: ESTHER RAMOS CASTELLANO — Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir (Doctoral School. Catholic University of Valencia San Vicente Mártir)
- Study coordinator: ESTHER RAMOS CASTELLANO
- Email: esther.ramos@ucv.es
- Phone: +34672425826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urinary Incontinence, Frailty, Balance Impairment, older women, pelvic floor, balance, multicomponent exercise, urinary incontinence