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

Not Applicable

Recruiting

• Conditions: Urinary Incontinence; Frailty; Balance Impairment

• Registration Number: NCT06839040
• Lead Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir

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.

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-03
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-16
• Last Update Submitted: 2025-02-16
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-12-02
• Study Completion: 2025-12-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pelvic floor	From enrollment to the end of treatment at 18 weeks.	Manometric perineometer: maximum contraction. Outcome measure in millimeters of mercury.
Abdominal muscle tone	From enrollment to the end of treatment at 18 weeks.	Abdominal ultrasound of rectus and transverse abdominis: in relaxation and activation with diaphragmatic breathing. Outcome measure in milimeters.
Dynamic balance	From enrollment to the end of treatment at 18 weeks	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.
Static balance	From enrollment to the end of treatment at 18 weeks.	Functional reach: distance traveled in anterior displacement with arms outstretched and feet together. Outcome measure in centimeters.
Gait	From enrollment to the end of treatment at 18 weeks	Six minutes gait with Runscribe sensors on feet and four meters gait (normal and fast speed)
Power	From enrollment to the end of treatment at 18 weeks	Jumps (CMJ and ABK), leg extension and squad. Outcome measure in wats.
Power and strenght	From enrollment to the end of treatment at 18 weeks	Five sit to stand, thirty sit to stand and arm curl. Outcome measure in number of repetitions in 30 seconds.
Strenght and endurance	From enrollment to the end of treatment at 18 weeks	Isometries of leg extension, hip extension, hip abduction, hip adduction, spine extension and hand grip. Outcome measure in newtons.
Health impact and quality of life	From enrollment to the end of treatment at 18 weeks.	International Consultation on Incontinence Questionnaire (ICIQ-SF): 0 to 21 points from urinary incontinence impact. Outcome measure in units on a scale.
Psychological and social well-being	From enrollment to the end of treatment at 18 weeks.	Falls efficacy scale: 16 to 64 points from least to most worry about falling. Outcome measure in units on a scale.

Secondary Outcome Measures

Name	Time	Method
Quality of live	From enrollment to the end of treatment at 18 weeks	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.
Psychological and social well-being	From enrollment to the end of treatment at 18 weeks.	Self-esteem questionnaire of Rosenberg: 10 points low self-esteem to 40 points high self-esteem. Outcome measure in units on a scale.
Weight	From enrollment to the end of treatment at 18 weeks	Kilograms and information on percentage of lean mass and fat mass.
Height	From enrollment to the end of treatment at 18 weeks	Stadiometer. Outcome measure in centimeters

Trial Locations

Locations (1)

Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of ValenciaSan Vicente Mártir); 🇪🇸 Valencia, Spain