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

NCT06839040 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-02-21

No results posted yet for this 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.

Conditions

Interventions

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.

OTHER

Group 2: ExVerb

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

OTHER

Group 3: Ex

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

Sponsors & Collaborators

  • University of Valencia

    collaborator OTHER
  • Fundación Universidad Católica de Valencia San Vicente Mártir

    lead OTHER

Principal Investigators

  • ESTHER RAMOS CASTELLANO · Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir (Doctoral School. Catholic University of Valencia San Vicente Mártir)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2025-12-02
Completion
2025-12-28

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06839040 on ClinicalTrials.gov