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| Name | Class |
|---|---|
| University of Valencia | OTHER |
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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:
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.
The aging process can lead to the development of major geriatric syndromes, such as falls and urinary incontinence. Although there are studies demonstrating the effectiveness of physical exercise and education in addressing these conditions, there is currently very limited evidence on the combined effects of both therapies on these syndromes.
The primary objective of this study is to evaluate the effects of a multidisciplinary intervention consisting of physiotherapy, physical exercise, and psychoeducation on the risk of falls and urinary incontinence in older adult women.
Methods: This will be a quantitative, quasi-experimental, and longitudinal study with 18 weeks of intervention and a 24-week follow-up period. The study is scheduled to begin in January 2025. The sample will consist of non-institutionalized older adult women aged between 60 and 80 years, who will be randomly assigned to one of four groups:
Multicomponent exercise sessions will be conducted twice a week and will include exercises focused on balance, strength/power using elastic bands, aerobic capacity, and coordination. The verbal instructions for the pelvic floor will involve performing fast and slow contractions during the general exercises. Participants in the psychoeducation group will attend five group therapy sessions throughout the program.
The study will analyze variables related to balance (Timed Up and Go test, functional reach test, and posturography), lower limb strength/power (isometric strength tests and jump performance), and pelvic floor function (using the PERFECT scale and electromyography). Additionally, physical, psychological, and social well-being variables will be assessed using instruments such as the SF-36, ICIQ-SF, and Rosenberg self-esteem scale.
Results/Conclusion: It is anticipated that differences will emerge between the study groups, with the trimodal intervention group (multicomponent exercise + specific verbal instructions for the pelvic floor + psychoeducation) showing greater improvements in certain parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-component exercise group with verbal instructions for the pelvic floor and psychoeducation | Experimental | 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. |
|
| Multi-component exercise group with verbal instructions for the pelvic floor | Active Comparator | The same procedure as experimental group 1 (exercise + verbal instructions + psychoeducation) will be performed except for the psychoeducation sessions. |
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| Multicomponent exercise group without verbal instructions for the pelvic floor | Active Comparator | The same procedure as experimental group 1 (exercise + verbal instructions + psychoeducation) will be performed but without verbal instructions and psychoeducation sessions. |
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| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment at 18 weeks |
| Pelvic floor | Intracavitary electromyography: maximum and average contraction. Outcome measure in microvolts. | From enrollment to the end of treatment at 18 weeks. |
| Pelvic floor | Manometric perineometer: maximum contraction. Outcome measure in millimeters of mercury. | From enrollment to the end of treatment at 18 weeks. |
| Abdominal muscle tone | Abdominal ultrasound of rectus and transverse abdominis: in relaxation and activation with diaphragmatic breathing. Outcome measure in milimeters. | From enrollment to the end of treatment at 18 weeks. |
| Dynamic balance | 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. | From enrollment to the end of treatment at 18 weeks |
| Static balance | 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. | From enrollment to the end of treatment at 18 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ESTHER RAMOS CASTELLANO | Contact | +34672425826 | esther.ramos@ucv.es |
| Name | Affiliation | Role |
|---|---|---|
| ESTHER RAMOS CASTELLANO | Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir (Doctoral School. Catholic University of Valencia San Vicente Mártir) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of ValenciaSan Vicente Mártir) | Recruiting | Valencia | Valencia | 46001 | Spain |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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This will be a double blind (investigator-evaluator/data analyst), four arm experimental, parallel and longitudinal study.
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| Group 2: ExVerb | Other | The same procedure as experimental group 1 ExVerbPsy will be performed except for the psychoeducation sessions. |
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| Group 3: Ex | Other | The same procedure as experimental group 1 ExVerbPsy will be performed but without verbal instructions and psychoeducation sessions. |
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| Static balance | 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. | From enrollment to the end of treatment at 18 weeks. |
| Static balance | Functional reach: distance traveled in anterior displacement with arms outstretched and feet together. Outcome measure in centimeters. | From enrollment to the end of treatment at 18 weeks. |
| Gait | Six minutes gait with Runscribe sensors on feet and four meters gait (normal and fast speed) | From enrollment to the end of treatment at 18 weeks |
| Power | Jumps (CMJ and ABK), leg extension and squad. Outcome measure in wats. | From enrollment to the end of treatment at 18 weeks |
| Power and strenght | Five sit to stand, thirty sit to stand and arm curl. Outcome measure in number of repetitions in 30 seconds. | From enrollment to the end of treatment at 18 weeks |
| Strenght and endurance | Isometries of leg extension, hip extension, hip abduction, hip adduction, spine extension and hand grip. Outcome measure in newtons. | From enrollment to the end of treatment at 18 weeks |
| Health impact and quality of life | International Consultation on Incontinence Questionnaire (ICIQ-SF): 0 to 21 points from urinary incontinence impact. Outcome measure in units on a scale. | From enrollment to the end of treatment at 18 weeks. |
| Psychological and social well-being | Falls efficacy scale: 16 to 64 points from least to most worry about falling. Outcome measure in units on a scale. | From enrollment to the end of treatment at 18 weeks. |
| 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. | From enrollment to the end of treatment at 18 weeks. |
| Weight | Kilograms and information on percentage of lean mass and fat mass. | From enrollment to the end of treatment at 18 weeks |
| Height | Stadiometer. Outcome measure in centimeters | From enrollment to the end of treatment at 18 weeks |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |