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

NCT ID: NCT06839040

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2025-12-28

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.

Conditions

Urinary Incontinence; Frailty; Balance Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Multi-component exercise group with verbal instructions for the pelvic floor and psychoeducation

A multidisciplinary intervention will be carried out, consisting of an initial phase of individual physiotherapy based on specific active muscle training of the pelvic floor (EMSP). This will be followed by a group-based multi-component physical exercise program with instructions on pelvic floor contraction during the exercises, and psychoeducation sessions to help cope with the fear of increased likelihood of falls and urinary incontinence as a result of aging.

Group Type: EXPERIMENTAL

Group 1: ExVerbPsy

Intervention Type: OTHER

A multidisciplinary intervention will be carried out, consisting of an initial phase of individual physiotherapy based on specific active muscle training of the pelvic floor (EMSP). This will be followed by a group-based multi-component physical exercise program with instructions on pelvic floor contraction during the exercises, and psychoeducation sessions to help cope with the fear of increased likelihood of falls and urinary incontinence as a result of aging.

Multi-component exercise group with verbal instructions for the pelvic floor

The same procedure as experimental group 1 (exercise + verbal instructions + psychoeducation) will be performed except for the psychoeducation sessions.

Group Type: ACTIVE_COMPARATOR

Group 2: ExVerb

Intervention Type: OTHER

The same procedure as experimental group 1 ExVerbPsy will be performed except for the psychoeducation sessions.

Multicomponent exercise group without verbal instructions for the pelvic floor

The same procedure as experimental group 1 (exercise + verbal instructions + psychoeducation) will be performed but without verbal instructions and psychoeducation sessions.

Group Type: ACTIVE_COMPARATOR

Group 3: Ex

Intervention Type: OTHER

The same procedure as experimental group 1 ExVerbPsy will be performed but without verbal instructions and psychoeducation sessions.

Control group

They will receive information sessions on the prevention of geriatric syndromes and will be asked to maintain their normal activity level. At the end of the interventions, this group will have the option of receiving the appropriate intervention that was not carried out in the initial process.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group 1: ExVerbPsy

A multidisciplinary intervention will be carried out, consisting of an initial phase of individual physiotherapy based on specific active muscle training of the pelvic floor (EMSP). This will be followed by a group-based multi-component physical exercise program with instructions on pelvic floor contraction during the exercises, and psychoeducation sessions to help cope with the fear of increased likelihood of falls and urinary incontinence as a result of aging.

Intervention Type: OTHER

Group 2: ExVerb

The same procedure as experimental group 1 ExVerbPsy will be performed except for the psychoeducation sessions.

Intervention Type: OTHER

Group 3: Ex

The same procedure as experimental group 1 ExVerbPsy will be performed but without verbal instructions and psychoeducation sessions.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Valencia

OTHER

Sponsor Role: collaborator

Fundación Universidad Católica de Valencia San Vicente Mártir

OTHER

Sponsor Role: lead

Responsible Party

Jorge Alarcón Jiménez

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ESTHER RAMOS CASTELLANO

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Valencia, Valencia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

ESTHER RAMOS CASTELLANO

Role: CONTACT

esther.ramos@ucv.es

+34672425826

Facility Contacts

Pedro Gargallo Bayo, Full professor

Role: primary

pedro.gargallo@uv.es

ESTHER RAMOS CASTELLANO

Role: backup

esther.ramos@ucv.es

+34672425826

Other Identifiers

UCV/2022-2023/123

Identifier Type: -

Identifier Source: org_study_id