Prevalence and Consequences of Urinary Incontinence in People with Chronic Pulmonary Diseases Referred for Pulmonary Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 341
- 试验地点
- 2
- 主要终点
- Prevalence of urinary incontinence symptoms
研究概览
简要总结
Urinary incontinence is a frequent chronic condition in general population. It is even more frequent in people with chronic respiratory disease due to several factors, including but not limited to frequent cough. Urinary incontinence may be more frequent during exercise so that it may contribute to the general deconditioning associated with chronic respiratory disease.
Although pulmonary rehabilitation is a cornerstone in the management of people with chronic respiratory disease to break this spiral of worsening dyspnea, little is known about the prevalence of urinary incontinence among those people referred for pulmonary rehabilitation nor about its impact on the effects of the program.
详细描述
Experimental design:
People referred for pulmonary rehabilitation in two centres will be offer to participate in the study. Those people who will agree to participate and give their formal consent will be asked to answer two questionnaires about urinary incontinence symptoms (see outcomes) to assess the prevalence and the type of these symptoms.
They will subsequently participate in their usual pulmonary rehabilitation program consisting in 90min sessions (including endurance training, muscle strengthening and self-management), 3x/week for 8weeks (centre 1) or 2x60min sessions (including the same components), 3x/week for 8weeks (centre 2).
The effects of the pulmonary rehabilitation program on usual clinical outcomes (according to each centre routine practice; tests may differ between centres) will be compared between those people with or without urinary incontinence symptoms.
As no prevalence data about urinary incontience was available at the time of study design, we planned to recruit the first 100 participants within the first year and to update the sample size calculation based on these preliminary data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 ans ;
- •Referred for pulmonary rehabilitation ;
- •Non inclusion Criteria:
- •History of pathology or prostate surgery ;
- •Contra indication to pulmonary rehabilitation ;
排除标准
- •Pregnant woman or likely to be ;
- •Patient under guardianship ;
- •Patient withdrawal ;
- •Did not complete at least 18 pulmonary rehabilitation sessions.
结局指标
主要结局
Prevalence of urinary incontinence symptoms
时间窗: The questionnaire will be administered at the end of the program (8weeks)
The prevalence of urinary incontinence symptoms will be assessed using the International Consultation on Incontinence Short Form
次要结局
- Type of urinary incontinence symptoms(The questionnaire will be administered at the end of the program (8weeks))
- Exercise capacity - Six-minute walk test (meters)(The test will be administered at the end of the program (8weeks))
- Mood status - Anxiety(The questionnaire will be administered at the end of the program (8weeks))
- Mood status - Depression(The questionnaire will be administered at the end of the program (8weeks))
- Quality of life - Saint Georges Respiratory Questionnaire (ranging from 0 to 100, higher score indicates worst quality of life)(The questionnaire will be administered at the end of the program (8weeks))
- Exercise capacity - Six-minute stepper test (steps)(The test will be administered at the end of the program (8weeks))
- Exercise capacity - Constant workload exercise testing(The test will be administered at the end of the program (8weeks))