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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60-80
SponsorFundación Universidad Católica de Valencia San Vicente Mártir

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group 1: ExVerbPsy

    Other intervention

    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 intervention

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

  • Group 3: Ex

    Other intervention

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

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Multi-component exercise group with verbal instructions for the pelvic floor and psychoeducationExperimental treatment 1 intervention
Group B: Multi-component exercise group with verbal instructions for the pelvic floorActive comparator 1 intervention
Group C: Multicomponent exercise group without verbal instructions for the pelvic floorActive comparator 1 intervention
Group D: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From enrollment to the end of treatment at 18 weeks
2

Pelvic floor

Intracavitary electromyography: maximum and average contraction. Outcome measure in microvolts.

Time frame
From enrollment to the end of treatment at 18 weeks.
3

Pelvic floor

Manometric perineometer: maximum contraction. Outcome measure in millimeters of mercury.

Time frame
From enrollment to the end of treatment at 18 weeks.
4

Abdominal muscle tone

Abdominal ultrasound of rectus and transverse abdominis: in relaxation and activation with diaphragmatic breathing. Outcome measure in milimeters.

Time frame
From enrollment to the end of treatment at 18 weeks.

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 18 weeks
2

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.

Time frame
From enrollment to the end of treatment at 18 weeks.
3

Weight

Kilograms and information on percentage of lean mass and fat mass.

Time frame
From enrollment to the end of treatment at 18 weeks
4

Height

Stadiometer. Outcome measure in centimeters

Time frame
From enrollment to the end of treatment at 18 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.