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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Group 2: ExVerb: The same procedure as experimental group 1 ExVerbPsy will be performed except for the psychoeducation sessions.

Group 3: Ex: The same procedure as experimental group 1 ExVerbPsy will be performed but without verbal instructions and psychoeducation sessions.

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.

Eligibility

Primary outcome measure(s)

• Pelvic floor — From enrollment to the end of treatment at 18 weeks
  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 — From enrollment to the end of treatment at 18 weeks.
  Intracavitary electromyography: maximum and average contraction. Outcome measure in microvolts.
• Pelvic floor — From enrollment to the end of treatment at 18 weeks.
  Manometric perineometer: maximum contraction. Outcome measure in millimeters of mercury.
• Abdominal muscle tone — From enrollment to the end of treatment at 18 weeks.
  Abdominal ultrasound of rectus and transverse abdominis: in relaxation and activation with diaphragmatic breathing. Outcome measure in milimeters.
• Dynamic balance — From enrollment to the end of treatment at 18 weeks
  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.
• Static balance — From enrollment to the end of treatment at 18 weeks.
  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.
• Static balance — From enrollment to the end of treatment at 18 weeks.
  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.
• Static balance — From enrollment to the end of treatment at 18 weeks.
  Functional reach: distance traveled in anterior displacement with arms outstretched and feet together. Outcome measure in centimeters.
• Gait — From enrollment to the end of treatment at 18 weeks
  Six minutes gait with Runscribe sensors on feet and four meters gait (normal and fast speed)
• Power — From enrollment to the end of treatment at 18 weeks
  Jumps (CMJ and ABK), leg extension and squad. Outcome measure in wats.
• Power and strenght — From enrollment to the end of treatment at 18 weeks
  Five sit to stand, thirty sit to stand and arm curl. Outcome measure in number of repetitions in 30 seconds.
• Strenght and endurance — From enrollment to the end of treatment at 18 weeks
  Isometries of leg extension, hip extension, hip abduction, hip adduction, spine extension and hand grip. Outcome measure in newtons.
• Health impact and quality of life — From enrollment to the end of treatment at 18 weeks.
  International Consultation on Incontinence Questionnaire (ICIQ-SF): 0 to 21 points from urinary incontinence impact. Outcome measure in units on a scale.
• Psychological and social well-being — From enrollment to the end of treatment at 18 weeks.
  Falls efficacy scale: 16 to 64 points from least to most worry about falling. Outcome measure in units on a scale.

Trial sites (1)

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