NCT Number: NCT04380558
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.
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Notify Me18 year and older
All sexes
Observational
ADIR Association, Bois-Guillaume, France
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.
Among the 70 people actually included, 21 (30%) experienced urinary incontinence. Therefore, assuming a true prevalence of 30% in this population and a total width for the 95% confidence interval of 10%, we planned to recruit a total 341 participants.
The ethical approval to recruit this updated number of participants and to increase the duration of recruitment accordingly was obtained.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non inclusion Criteria:
Exclusion criteria
Patients 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).
Time frame: The questionnaire will be administered at baseline
The prevalence of urinary incontinence symptoms will be assessed using the International Consultation on Incontinence Short Form
Time frame: 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
Time frame: The questionnaire will be administered at baseline
The type of urinary incontinence symptoms will be assessed using the Urinary Symptom Profile questionnaire.
Time frame: The questionnaire will be administered at the end of the program (8weeks)
The type of urinary incontinence symptoms will be assessed using the Urinary Symptom Profile questionnaire.
Time frame: The test will be administered at baseline
The six-minute walk test will be performed before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 25meters will be compared between those people with or without urinary incontinence symptoms.
Time frame: The test will be administered at the end of the program (8weeks)
The six-minute walk test will be performed before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 25meters will be compared between those people with or without urinary incontinence symptoms.
Time frame: The test will be administered at baseline
The six-minute stepper test will be performed before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 20steps will be compared between those people with or without urinary incontinence symptoms.
Time frame: The test will be administered at the end of the program (8weeks)
The six-minute stepper test will be performed before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 20steps will be compared between those people with or without urinary incontinence symptoms.
Time frame: The test will be administered at baseline
The constant workload exercise testing will be performed before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 101sec will be compared between those people with or without urinary incontinence symptoms.
Time frame: The test will be administered at the end of the program (8weeks)
The constant workload exercise testing will be performed before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 101sec will be compared between those people with or without urinary incontinence symptoms.
Time frame: The questionnaire will be administered at baseline
The questionnaire will be administered before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 4points will be compared between those people with or without urinary incontinence symptoms.
Time frame: The questionnaire will be administered at the end of the program (8weeks)
The questionnaire will be administered before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 4points will be compared between those people with or without urinary incontinence symptoms.
Time frame: The questionnaire will be administered at baseline
Anxiety will be assessed using the Hospital Anxiety and Depression Scale (ranging for 0 to 15, higher score indicates worst anxiety)
Time frame: The questionnaire will be administered at the end of the program (8weeks)
Anxiety will be assessed using the Hospital Anxiety and Depression Scale (ranging for 0 to 15, higher score indicates worst anxiety)
Time frame: The questionnaire will be administered at baseline
Depression will be assessed using the Hospital Anxiety and Depression Scale (ranging for 0 to 15, higher score indicates worst anxiety)
Time frame: The questionnaire will be administered at the end of the program (8weeks)
Depression will be assessed using the Hospital Anxiety and Depression Scale (ranging for 0 to 15, higher score indicates worst anxiety)
ADIR Association
Other
Acronym: PRECUI-PR
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