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

Sponsor
Fundación Universidad Católica de Valencia San Vicente Mártir
Study ID
NCT06839040
Status
Recruiting
Apply to this trial

Conditions

  • Balance Impairment
  • Frailty
  • Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
60 Years - 80 Years
Healthy Volunteers
Accepted

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.
  • Group 2: ExVerb — OTHER
    The same procedure as experimental group 1 ExVerbPsy will be performed except for the psychoeducation sessions.
  • Group 3: Ex — OTHER
    The same procedure as experimental group 1 ExVerbPsy will be performed but without verbal instructions and psychoeducation sessions.

Study Details

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.

Key Dates

First listed
Feb 21, 2025
Start date
Feb 3, 2025
Status verified
Feb 2025
Primary completion
Dec 2, 2025
Completion
Dec 28, 2025

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Pelvic floor [ Time Frame: From enrollment to the end of treatment at 18 weeks ]

Central Contacts

Related Studies