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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Group 1: ExVerbPsy
Other interventionA 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 interventionThe same procedure as experimental group 1 ExVerbPsy will be performed except for the psychoeducation sessions.
Group 3: Ex
Other interventionThe same procedure as experimental group 1 ExVerbPsy will be performed but without verbal instructions and psychoeducation sessions.
Treatment groups
Trial outcomes
Primary outcomes
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
Pelvic floor
Intracavitary electromyography: maximum and average contraction. Outcome measure in microvolts.
Pelvic floor
Manometric perineometer: maximum contraction. Outcome measure in millimeters of mercury.
Abdominal muscle tone
Abdominal ultrasound of rectus and transverse abdominis: in relaxation and activation with diaphragmatic breathing. Outcome measure in milimeters.
Secondary outcomes
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.
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.
Weight
Kilograms and information on percentage of lean mass and fat mass.
Height
Stadiometer. Outcome measure in centimeters
Sponsors and contacts
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Fundación Universidad Católica de Valencia San Vicente Mártir
Lead sponsor
University of Valencia
Collaborator