Effects of a Multidisciplinary Intervention on Fall Risk and Urinary Incontinence in Older Women

Last updated: February 16, 2025
Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Incontinence

Enuresis

Treatment

Group 1: ExVerbPsy

Group 2: ExVerb

Group 3: Ex

Clinical Study ID

NCT06839040
UCV/2022-2023/123
  • Ages 60-80
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 ofphysical exercise.

  • Not present severe cognitive alterations or mild cognitive deficit (GlobalDeterioration Scale less than or equal to 2 or Mini Mental State Examination greaterthan or equal to 25 points).

  • Maintain walking without support products.

  • Carry out 80% of the total sessions

Exclusion

Exclusion Criteria:

  • Intake of medication that could affect the performance of the exercise or alter thevariables 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 ofthe intervention and evaluation.

  • Present visual and/or auditory alterations that make it difficult to carry out theintervention and evaluation.

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Group 1: ExVerbPsy
Phase:
Study Start date:
February 03, 2025
Estimated Completion Date:
December 28, 2025

Study 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.

Connect with a study center

  • Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of ValenciaSan Vicente Mártir)

    Valencia, 46001
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.