Clinical trial NCT06839040: Effects of a Multidisciplinary Intervention on Fall Risk and Urinary Incontinence in Older Women
Official title: Effects of a Multidisciplinary Intervention on Fall Risk and Urinary Incontinence in Older Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Frailty
Balance Impairment
Keywords: older women
pelvic floor
balance
multicomponent exercise
urinary incontinence
phsychoeducation
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2025-02-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a double blind (investigator-evaluator/data analyst), four arm experimental, parallel and longitudinal study.
Primary purpose: TREATMENT

Brief summary: This will be a quantitative, quasi-experimental, and longitudinal study spanning 18 weeks of intervention, followed by a 24-week follow-up, scheduled to begin in January 2025.

The primary objective of this study is to evaluate the effects of a multidisciplinary intervention comprising physiotherapy, physical exercise, and psychoeducation on fall risk and urinary incontinence in non-institutionalized older adult women aged 60 to 80 years. Participants will be randomly assigned to one of four groups:

1. A multicomponent exercise group with verbal instructions for pelvic floor exercises.
2. A multicomponent exercise group with verbal instructions for pelvic floor exercises and psychoeducation.
3. A multicomponent exercise group without verbal instructions for pelvic floor exercises.
4. A control group.

Multicomponent exercise sessions will be conducted twice a week, while the psychoeducation group will participate in five group therapy sessions throughout the program. The variables to be analyzed include balance, strength, power, pelvic floor function, quality of life, and self-esteem.

Detailed description: The aging process can lead to the development of major geriatric syndromes, such as falls and urinary incontinence. Although there are studies demonstrating the effectiveness of physical exercise and education in addressing these conditions, there is currently very limited evidence on the combined effects of both therapies on these syndromes.

The primary objective of this study is to evaluate the effects of a multidisciplinary intervention consisting of physiotherapy, physical exercise, and psychoeducation on the risk of falls and urinary incontinence in older adult women.

Methods: This will be a quantitative, quasi-experimental, and longitudinal study with 18 weeks of intervention and a 24-week follow-up period. The study is scheduled to begin in January 2025. The sample will consist of non-institutionalized older adult women aged between 60 and 80 years, who will be randomly assigned to one of four groups:

1. A multicomponent exercise group with verbal instructions targeting the pelvic floor.
2. A multicomponent exercise group with verbal instructions targeting the pelvic floor and psychoeducation.
3. A multicomponent exercise group without verbal instructions targeting the pelvic floor.
4. A control group.

Multicomponent exercise sessions will be conducted twice a week and will include exercises focused on balance, strength/power using elastic bands, aerobic capacity, and coordination. The verbal instructions for the pelvic floor will involve performing fast and slow contractions during the general exercises. Participants in the psychoeducation group will attend five group therapy sessions throughout the program.

The study will analyze variables related to balance (Timed Up and Go test, functional reach test, and posturography), lower limb strength/power (isometric strength tests and jump performance), and pelvic floor function (using the PERFECT scale and electromyography). Additionally, physical, psychological, and social well-being variables will be assessed using instruments such as the SF-36, ICIQ-SF, and Rosenberg self-esteem scale.

Results/Conclusion: It is anticipated that differences will emerge between the study groups, with the trimodal intervention group (multicomponent exercise + specific verbal instructions for the pelvic floor + psychoeducation) showing greater improvements in certain parameters.

Eligibility 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.

Primary outcomes:
measure: Pelvic floor
timeFrame: From enrollment to the end of treatment at 18 weeks
measure: Pelvic floor
timeFrame: From enrollment to the end of treatment at 18 weeks.
measure: Pelvic floor
timeFrame: From enrollment to the end of treatment at 18 weeks.
measure: Abdominal muscle tone
timeFrame: From enrollment to the end of treatment at 18 weeks.
measure: Dynamic balance
timeFrame: From enrollment to the end of treatment at 18 weeks
measure: Static balance
timeFrame: From enrollment to the end of treatment at 18 weeks.
measure: Static balance
timeFrame: From enrollment to the end of treatment at 18 weeks.
measure: Static balance
timeFrame: From enrollment to the end of treatment at 18 weeks.
measure: Gait
timeFrame: From enrollment to the end of treatment at 18 weeks
measure: Power
timeFrame: From enrollment to the end of treatment at 18 weeks
measure: Power and strenght
timeFrame: From enrollment to the end of treatment at 18 weeks
measure: Strenght and endurance
timeFrame: From enrollment to the end of treatment at 18 weeks
measure: Health impact and quality of life
timeFrame: From enrollment to the end of treatment at 18 weeks.
measure: Psychological and social well-being
timeFrame: From enrollment to the end of treatment at 18 weeks.
Secondary outcomes:
measure: Quality of live
timeFrame: From enrollment to the end of treatment at 18 weeks
measure: Psychological and social well-being
timeFrame: From enrollment to the end of treatment at 18 weeks.
measure: Weight
timeFrame: From enrollment to the end of treatment at 18 weeks
measure: Height
timeFrame: From enrollment to the end of treatment at 18 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of ValenciaSan Vicente Mártir)
Study officials:
affiliation: Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir (Doctoral School. Catholic University of Valencia San Vicente Mártir)
name: ESTHER RAMOS CASTELLANO
role: PRINCIPAL_INVESTIGATOR
References: