Effects of a Multidisciplinary Intervention on Fall Risk and Urinary Incontinence in Older Women (FIRE-WOMEN)

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence; Frailty; Balance Impairment
• Intervention / Treatment: Other: Group 1: ExVerbPsy; Other: Group 2: ExVerb; Other: Group 3: Ex

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ESTHER RAMOS CASTELLANO; Phone Number: +34672425826; Email: esther.ramos@ucv.es

Study Locations

• Spain
  • Valencia, Spain, 46001
    • Recruiting
    • Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of ValenciaSan Vicente Mártir)
    • Contact: ESTHER RAMOS CASTELLANO; Phone Number: +34672425826; Email: esther.ramos@ucv.es
    • Contact: Pedro Gargallo Bayo, Full professor; Email: pedro.gargallo@uv.es
    • Contact: ESTHER RAMOS CASTELLANO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	Other: Group 2: ExVerb; The same procedure as experimental group 1 ExVerbPsy will be performed except for the psychoeducation sessions.
Active Comparator: 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.	Other: Group 3: Ex; The same procedure as experimental group 1 ExVerbPsy will be performed but without verbal instructions and psychoeducation sessions.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic floor	PERFECT Scale: Power (P): with Oxford scale 0 to 5 points Endurence (E): 0 to 10 points Repetitions (R): 0 to 10 points Fast (F): 0 to 10 points	From enrollment to the end of treatment at 18 weeks
Pelvic floor	Intracavitary electromyography: maximum and average contraction. Outcome measure in microvolts.	From enrollment to the end of treatment at 18 weeks.
Pelvic floor	Manometric perineometer: maximum contraction. Outcome measure in millimeters of mercury.	From enrollment to the end of treatment at 18 weeks.
Abdominal muscle tone	Abdominal ultrasound of rectus and transverse abdominis: in relaxation and activation with diaphragmatic breathing. Outcome measure in milimeters.	From enrollment to the end of treatment at 18 weeks.
Dynamic balance	Timed Up and Go: the time it takes for the person to get up from a chair, walk 3 meters, turn on a cone, return to the chair and sit down. Outcome measure in seconds. Less than 10 seconds: low risk of falling. Between 10 and 20 seconds: frailty (medium risk of falling). More than 20 seconds: high risk of falling and disability.	From enrollment to the end of treatment at 18 weeks
Static balance	Romberg test with feet together, semi-tandem and tandem in 10 seconds. Static one-leg standing balance test with open and closed eyes in 30 seconds. Outcome measure in seconds.	From enrollment to the end of treatment at 18 weeks.
Static balance	Posturography with and without balance foam: anteroposterior and lateral axis oscillation, and degree of shift of the center of gravity (COP). Outcome measure in milimeters.	From enrollment to the end of treatment at 18 weeks.
Static balance	Functional reach: distance traveled in anterior displacement with arms outstretched and feet together. Outcome measure in centimeters.	From enrollment to the end of treatment at 18 weeks.
Gait	Six minutes gait with Runscribe sensors on feet and four meters gait (normal and fast speed)	From enrollment to the end of treatment at 18 weeks
Power	Jumps (CMJ and ABK), leg extension and squad. Outcome measure in wats.	From enrollment to the end of treatment at 18 weeks
Power and strenght	Five sit to stand, thirty sit to stand and arm curl. Outcome measure in number of repetitions in 30 seconds.	From enrollment to the end of treatment at 18 weeks
Strenght and endurance	Isometries of leg extension, hip extension, hip abduction, hip adduction, spine extension and hand grip. Outcome measure in newtons.	From enrollment to the end of treatment at 18 weeks
Health impact and quality of life	International Consultation on Incontinence Questionnaire (ICIQ-SF): 0 to 21 points from urinary incontinence impact. Outcome measure in units on a scale.	From enrollment to the end of treatment at 18 weeks.
Psychological and social well-being	Falls efficacy scale: 16 to 64 points from least to most worry about falling. Outcome measure in units on a scale.	From enrollment to the end of treatment at 18 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of live	Quality of live with questionnaire Short Form (SF36): this questionnaire evalues in 36 questions the physical function, physical role, body pain, general health, vitality, social function, emotional role, and mental health. 0 to 100 points. Outcome measure in units on a scale.	From enrollment to the end of treatment at 18 weeks
Psychological and social well-being	Self-esteem questionnaire of Rosenberg: 10 points low self-esteem to 40 points high self-esteem. Outcome measure in units on a scale.	From enrollment to the end of treatment at 18 weeks.
Weight	Kilograms and information on percentage of lean mass and fat mass.	From enrollment to the end of treatment at 18 weeks
Height	Stadiometer. Outcome measure in centimeters	From enrollment to the end of treatment at 18 weeks

Collaborators and Investigators

• Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
• Collaborators: University of Valencia
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): December 2, 2025
• Study Completion (Estimated): December 28, 2025

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: balance; urinary incontinence; pelvic floor; older women; multicomponent exercise; phsychoeducation
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Frailty; Urinary Incontinence; Enuresis
• Other Study ID Numbers: UCV/2022-2023/123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No