To find the combined effects of pelvic floor Hold relax and Buteyko technique on urinary incontinence, pulmonary functions and exercise tolerance in COPD patients
Design
Randomized Controlled Trial
Settings and conduct
This Study will be conducted at Gulab Devi Chest Hospital, Lahore.
Participants/Inclusion and exclusion criteria
• Patients complaining incontinence link with cough and exercise.
• Age criteria 25-45 years
• Patients having ability to perform voluntary pelvic floor muscle contraction and cooperative.
• Self-reported urinary incontinence.
• Stable COPD
Exclusion Criteria:
• Subjects having unstable COPD.
• Also, the subjects with >4 hospital admissions due to COPD during last 1 year.
• Patient ‘s having Neurological conditions and non-cooperative.
• Subjects having spinal cord injuries.
• Patients having history of Hysterectomy and other gynecological surgeries
• Patients having Malignancy.
Intervention groups
Group A: will be treated by Behavioral Therapy along with Pelvic floor hold relax and Buteyko technique.
Group B: will be treated by Behavioral Therapy
Combined effects of pelvic floor Hold relax and Buteyko technique on urinary incontinence, pulmonary functions and exercise tolerance in COPD patients
Public title
Combined effects of pelvic floor Hold relax and Buteyko technique on urinary incontinence, pulmonary functions and exercise tolerance in COPD patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients complaining incontinence link with cough and exercise
Age criteria 25-45 years
Patients having ability to perform voluntary pelvic floor muscle contraction and cooperative
Self-reported urinary incontinence
Stable COPD
Exclusion criteria:
Subjects having unstable COPD
Subjects with >4 hospital admissions due to COPD during last 1 year
Patient ‘s having Neurological conditions and non-cooperative
Subjects having spinal cord injuries
Patients having history of Hysterectomy and other gynecological surgeries
Patients having Malignancy
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Taking into account the aforementioned inclusion and exclusion criteria patients will be divided into two groups by convenient sampling and allocated to 2 groups by simple randomization process by sealed opaque envelope method and labeled as 0 for group A and 1 for group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Investigator will be blind. Assessment will done by 2nd therapist who will not be involved in treatment and data analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah college of rehabilitation and Allied Health Sciences
Street address
13-14-C-civic center, township near Hamdard Chowk Lahore.
International consultation on Incontinence Questionnaire (ICIQ-UI-SF) and for pulmonary functions Master Screen PFT system
Secondary outcomes
1
Description
Exercise tolerance
Timepoint
Pre-Post Treatment
Method of measurement
6 Minute walk test
Intervention groups
1
Description
Intervention group: Behavioral Therapy along with Pelvic floor hold relax and Buteyko technique.Patients asked to do Pelvic floor hold relax like 3 sets of 8–12 maximum VPFMC and to hold the contraction for more than three seconds followed by relaxation. Begin by bladder emptying, patients squeeze the muscles around the urethra as if trying to stop the flow of urine.Buteyko technique given to patients like 8-10 repetitions of 3 sets Patient will be asked to maintain upright posture. In the 1st phase they will do normal breathing for few minutes. Use index finger and thumb to plug nose. After exhalation hold breath as they can, then again inhale and start breathing normally for 10 seconds. In 2nd phase patients will hold breath twice the timing of 1st phase. Patients were also instructed to do exercises for twice a week for 16 weeks.Educational session given to patients about Behavioral Therapy. It includes proper fluid intake schedule that is drink more fluids in the morning and afternoon, not at night. Stop drinking a few hours before bedtime, reducing alcohol, caffeine, spicy foods, voiding interval of 2-3 hours starting from 5 minutes, stop smoking, avoid lifting.
Category
Rehabilitation
2
Description
Control group: Behavioral Therapy.Educational session given to patients about Behavioral Therapy. It includes proper fluid intake schedule that is drink more fluids in the morning and afternoon, not at night. Stop drinking a few hours before bedtime, reducing alcohol, caffeine, spicy foods, voiding interval of 2-3 hours starting from 5 minutes, stop smoking, avoid lifting.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Riphah college of rehabilitation & Allied Health Sciences.
Full name of responsible person
Fazelat Nasir
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
fazelatmirza@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Grant name
Educational
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Fazelat Nasir
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-civic center, township near hamdard chowk, lahore.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha
Position
Senior Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-civic center, township near Hamdard chowk, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Fazelat Nasir
Position
Students
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
fazelatmirza@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available