MoVE on Up: Mobility and Voiding Exercises in Older Women With Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Change in number of falls between the baseline visit and 1 year
研究概览
简要总结
A prospective, two-arm randomized clinical trial utilizing a multidimensional intervention to reduce falls in older women with Urinary Urge Incontinence. The intervention consist of general balance and strength training, bladder training and urge suppression, and home hazard assessments. The control group will receive informational booklets on fall prevention and behavioral treatment for urinary urge incontinence.
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
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •70 or older
- •Living independently in the community
- •Willingness to be randomized.
- •Ability to read and understand English
- •Be able to provide informed consent
- •Low physical activity (physically active for 30 minutes or more less than or equal to 2 days per week on average over the past 6 months) per PAS
- •Ambulatory (defined as patient not confined to bed or wheelchair OR ability to walk with or without an assistive device)
- •Self-reported moderate to severe urge-predominant UI based on the ICIQ-SF > 6 (Q 1+2+3)
- •Not planning to initiate new UI or overactive bladder (OAB) treatment during the study duration
- •Capable of participation in an exercise program without exacerbating any pre-existing condition(s), as determined by the study PI or designee
排除标准
- •Pelvic organ prolapse passed the hymen (per patient report)
- •Undergoing active treatment for cancer (other than non-melanoma skin cancer)
- •Uncorrected visual or hearing loss.
- •Other urinary conditions or procedures that may affect continence status for example: urethral diverticulum, previous augmentation cystoplasty
- •Progressive neurodegenerative disease e.g. Parkinson's disease, multiple sclerosis per patient report
- •History of stroke or carotid sensitivity (i.e. syncopal falls) per patient report
- •Unstable cardiac disease per patient report
- •Fracture or joint replacement within the last six months per patient report
- •Significant cognitive impairment (defined as a modified TICs score of < 27)
- •Per PI discretion, participant cannot enroll in study
研究组 & 干预措施
Exercise Group
Participants in this group will participate in the home-based exercise group intervention that consists of general balance and strength training, bladder training and urge suppression, and home hazard assessments.
干预措施: Exercise Group (Behavioral)
Control Group
Participants in this group will receive informational booklets on fall prevention and behavioral treatment for Urgency Incontinence.
结局指标
主要结局
Change in number of falls between the baseline visit and 1 year
时间窗: 12 months
number of falls reported in a falls diary
次要结局
- Change in urinary incontinence score on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) between baseline visit and 1 year(12 months)
研究者
Uduak Andy
Associate Professor
University of Pennsylvania