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

NCT06839040 | Recruiting

• 1 other identifier: UCV/2022-2023/123
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Incontinence; Frailty; Balance Impairment

Keywords

older women; pelvic floor; balance; multicomponent exercise; urinary incontinence; phsychoeducation

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (4)

• Quality of live

  From enrollment to the end of treatment at 18 weeks

• Psychological and social well-being

  From enrollment to the end of treatment at 18 weeks.

• Weight

  From enrollment to the end of treatment at 18 weeks

• Height

  From enrollment to the end of treatment at 18 weeks

Study Arms (4)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Other: Group 2: ExVerb

Multicomponent exercise group without verbal instructions for the pelvic floor

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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.

Interventions

Group 1: ExVerbPsy 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 and psychoeducation

Group 2: ExVerb OTHER

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

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

Group 3: Ex OTHER

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

Multicomponent exercise group without verbal instructions for the pelvic floor

Eligibility Criteria

• Age: 60 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead
• University of Valencia: collaborator

Study Sites (1)

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

Valencia, Valencia, 46001, Spain

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence; Frailty

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• ESTHER RAMOS CASTELLANO

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ESTHER RAMOS CASTELLANO

CONTACT

+34672425826; esther.ramos@ucv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This will be a double blind (investigator-evaluator/data analyst), four arm experimental, parallel and longitudinal study.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 21, 2025
• Study Start: February 3, 2025
• Primary Completion: December 2, 2025
• Study Completion: December 28, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

ES (1)