Effects of a Multidisciplinary Intervention on Fall Risk and Urinary Incontinence in Older Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Abdominal muscle tone
研究概览
简要总结
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:
- A multicomponent exercise group with verbal instructions for pelvic floor exercises.
- A multicomponent exercise group with verbal instructions for pelvic floor exercises and psychoeducation.
- A multicomponent exercise group without verbal instructions for pelvic floor exercises.
- 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.
详细描述
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:
- A multicomponent exercise group with verbal instructions targeting the pelvic floor.
- A multicomponent exercise group with verbal instructions targeting the pelvic floor and psychoeducation.
- A multicomponent exercise group without verbal instructions targeting the pelvic floor.
- A control group.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
- •Not present pathologies or functional alterations that limit the practice of physical exercise.
- •Not present severe cognitive alterations or mild cognitive deficit (Global Deterioration Scale less than or equal to 2 or Mini Mental State Examination greater than or equal to 25 points).
- •Maintain walking without support products.
- •Carry out 80% of the total sessions
排除标准
- •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.
结局指标
主要结局
Abdominal muscle tone
时间窗: 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
时间窗: 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.
Gait
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Pelvic floor
时间窗: From enrollment to the end of treatment at 18 weeks.
Intracavitary electromyography: maximum and average contraction. Outcome measure in microvolts.
Static balance
时间窗: 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.
次要结局
- Quality of live(From enrollment to the end of treatment at 18 weeks)
- Psychological and social well-being(From enrollment to the end of treatment at 18 weeks.)
- Weight(From enrollment to the end of treatment at 18 weeks)
- Height(From enrollment to the end of treatment at 18 weeks)
研究者
Jorge Alarcón Jiménez
Professor
Fundación Universidad Católica de Valencia San Vicente Mártir