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Trial registered on ANZCTR


Registration number
ACTRN12619000784112
Ethics application status
Approved
Date submitted
5/05/2019
Date registered
27/05/2019
Date last updated
27/05/2019
Date data sharing statement initially provided
27/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Yoga and Pilates Training for Urinary Incontinence in Elderly Women: A Clinical Trial
Scientific title
Effectiveness of Yoga and Pilates Compared with Standard Care for Urinary Incontinence in Elderly Women: A Randomised Controlled Pilot Trial
Secondary ID [1] 297958 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Incontinence 312554 0
Condition category
Condition code
Renal and Urogenital 311074 311074 0 0
Other renal and urogenital disorders
Physical Medicine / Rehabilitation 311424 311424 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An assessor-blinded, prospective, three-arm parallel group randomized controlled pilot trial will be conducted over a period of 12 weeks with elderly women (n = 30) presenting with symptoms of stress or mixed urinary incontinence. The three intervention groups include Pilates (n = 10), Yoga (n = 10) and Standard Care as an active control group (n = 10).

"Arm 1: Standard Care"

For participants assigned to standard care group (n = 10), pelvic floor muscle training (PFMT) will be provided by a certified perineal therapist. The trainer will provide the intervention once a week for 4 weeks, with each session lasting 45 minutes to one hour, in the form of group classes to a group of 10 in an elderly centre in Hong Kong. At the end of this 4-week training, all participants will receive a CD with videos taken when the trainer conducts her sessions at the centre. All study participants will be required to perform CD-guided unsupervised home exercises 3 to 6 times per week for 8 weeks. Each of the home exercise sessions last 30 to 45 minutes. PFMT will first be taught in a position in which gravity is eliminated (lying) and will gradually progress to positions in which gravity is partially eliminated, followed by movements that are against gravity. The procedures of PFMT are as follows:

Step 1: women will be asked to contract their pelvic floor muscles (urethra) and hold the contraction for 3-6 seconds, then relax for another 10 seconds.

Step 2: women will be asked to control the bowel action (or control passage of wind), hold it for 3-6 seconds and then relax for another 10 seconds.

Step 3: women will be asked to contract their urethral orifice and control bowel action, draw the vagina up and hold it for 3-6 seconds and then relax for another 10 seconds. This exercise will improve the strength of the entire pubococcygeus muscle i.e., the pelvic floor muscles.

"Arm 2: Pilates"

For participants assigned to Pilates group (n = 10), Pilates training will be provided by a Pilates trainer once a week for 4 weeks, with each session lasting 45 minutes to one hour, in the form of group classes to a group of 10 in an elderly centre in Hong Kong. At the end of this 4-week training, all participants will receive a CD with videos taken when the trainer conducts her sessions at the centre. All study participants will be required to perform CD-guided unsupervised home exercises 3 to 6 times per week for 8 weeks. Each of the home exercise sessions last 30 to 45 minutes. Pilates will first be taught in a position in which gravity is eliminated (lying) and will gradually progress to positions in which gravity is partially eliminated, followed by movements that are against gravity.

Warm-up exercises for Pilates will include: roll down, leg springs, walking, frog, circles, single leg stretch, scissors, lower and lift, spine stretch, swan prep, and crisscross.

Pilates training will include: Pilates breathing, neutral pelvis, knee folds, knee sways, heel slides, elevator, pelvic clock, pelvic rocks, coccyx curl, pelvic lift, bridging, and abdominal stabilization.

"Arm 3: Yoga"

For participants assigned to Yoga group (n = 10), Yoga will be provided by a certificated Yoga trainer with 500 hours of Yoga training in the Yoga school. The trainer will provide the intervention once a week for 4 weeks, with each session lasting one hour, in the form of group classes to a group of 10 in an elderly centre in Hong Kong. At the end of this 4-week training, all participants will receive a CD with videos taken when the trainer conducts her sessions at the centre. All study participants will be required to perform CD-guided unsupervised home exercises 3 to 6 times per week for 8 weeks. Each of the home exercise sessions last 30 to 45 minutes. The yoga postures used are as follows:

Hatha yoga styles, which include 8 postures, will be performed: Tadasana, Utkatasana, Trikonasana, Malasana, Viparita Karani Variation, Salamba Set Bandhasana, Supta Baddha Konasana, and Savasana.

"Adherence to Schedules"

Researchers will telephone each patient every week to ensure patients’ adherence to schedules over the period of 8 weeks of CD-guided unsupervised home exercises.
Intervention code [1] 314292 0
Rehabilitation
Intervention code [2] 314293 0
Lifestyle
Comparator / control treatment
As an active control group, patients (n = 10) will be assigned to receive standard care.

For participants assigned to standard care group (n = 10), pelvic floor muscle training (PFMT) will be provided by a certified perineal therapist. The trainer will provide the intervention once a week for 4 weeks, with each session lasting 45 minutes to one hour, in the form of group classes to a group of 10 in an elderly centre in Hong Kong. At the end of this 4-week training, all participants will receive a CD with videos taken when the trainer conducts her sessions at the centre. All study participants will be required to perform CD-guided unsupervised home exercises 3 to 6 times per week for 8 weeks. Each of the home exercise sessions last 30 to 45 minutes. PFMT will first be taught in a position in which gravity is eliminated (lying) and will gradually progress to positions in which gravity is partially eliminated, followed by movements that are against gravity. The procedures of PFMT are as follows:

Step 1: women will be asked to contract their pelvic floor muscles (urethra) and hold the contraction for 3-6 seconds, then relax for another 10 seconds.

Step 2: women will be asked to control the bowel action (or control passage of wind), hold it for 3-6 seconds and then relax for another 10 seconds.

Step 3: women will be asked to contract their urethral orifice and control bowel action, draw the vagina up and hold it for 3-6 seconds and then relax for another 10 seconds. This exercise will improve the strength of the entire pubococcygeus muscle i.e., the pelvic floor muscles.
Control group
Active

Outcomes
Primary outcome [1] 319856 0
One-hour pad test combined with stress test will be used to measure the amount of urinary leakage. Women are asked to first empty their bladders, wear pads and drink 500 ml of water. They are then instructed to perform a standardized set of activities for 30 minutes, including walking, climbing up and down stairs, sit-to-stand, coughing vigorously, running on the spot, bending to pick up an object from the floor and washing hands in running water. Before and after the test, the weight of the pad is measured with a high-precision balance in order to determine the amount of leakage.
Timepoint [1] 319856 0
The outcome measure will be conducted 3 times, at baseline, at the end of 4 weeks of training by certified instructors and after that at the end of 8 weeks of CD-home guided exercise.
Secondary outcome [1] 369724 0
The International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) will be used. Both the English version and the Chinese (traditional) version will be provided.
Timepoint [1] 369724 0
The outcome measure will be conducted 3 times, at baseline, at the end of 4 weeks of training by certified instructors and after that at the end of 8 weeks of CD-home guided exercise.

Eligibility
Key inclusion criteria
1. Women aged 60 or above
2. Women presenting with symptoms of stress urinary incontinence at a bladder volume 200 to 250 ml (involuntary loss of urine on effort or physical exertion, or on sneezing or coughing), or mixed urinary incontinence (stress and urgency incontinence)
3. International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form (ICIQ-UI-SF) at least 6 points (out of 21)
4. Provision of written informed consent
Minimum age
60 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women having pure urgency urinary incontinence
2. Women having urinary incontinence caused by other diseases, such as Parkinson’s Disease, multiple sclerosis, spinal cord injury or Alzheimer’s disease.
3. Women having cognitive impairment (Mini-Mental State Examination [MMSE] score < 23) that affects their capacity to give informed consent
4. Women who have been diagnosed Stage 3 or 4 pelvic organ prolapse according to Pelvic Organ Prolapse Quantification System
5. Women who have been diagnosed, and currently having treatment for pelvic cancer
6. Women who have urinary tract infection or haematuria
7. Women who suspected urethral and/or vesical fistula
8. Women who are bedridden
9. Women who are currently participating in other research relating to urinary incontinence

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21435 0
Hong Kong
State/province [1] 21435 0

Funding & Sponsors
Funding source category [1] 302478 0
University
Name [1] 302478 0
The Hong Kong Polytechnic University
Address [1] 302478 0
The Hong Kong Polytechnic University
11 Yuk Choi Road
Hung Hom, New Territories
Hong Kong
Country [1] 302478 0
Hong Kong
Primary sponsor type
Individual
Name
Priya Kannan
Address
Room ST532
The Hong Kong Polytechnic University
11 Yuk Choi Road
Hung Hom, New Territories
Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 302500 0
None
Name [1] 302500 0
Address [1] 302500 0
Country [1] 302500 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303140 0
Human Subjects Ethics Sub-committee (HSESC)
Ethics committee address [1] 303140 0
The Hong Kong Polytechnic University
11 Yuk Choi Road
Hung Hom, New Territories
Hong Kong
Ethics committee country [1] 303140 0
Hong Kong
Date submitted for ethics approval [1] 303140 0
03/05/2019
Approval date [1] 303140 0
09/05/2019
Ethics approval number [1] 303140 0
HSEARS20190509001

Summary
Brief summary
The purpose of the clinical trial is to assess the effectiveness of Yoga and Pilates compared with standard care on urinary incontinence among elderly women. A total of 30 participants will be divided into to three groups of 10 to receive either Yoga or Pilates or Standard Care once a week for 4 weeks provided by the respective trained professionals in the form of group classes in an elderly centre. All study participants will be required to perform CD-guided home exercises for 8 weeks without trainers’ supervision after the 4-week training.

The study will determine the effectiveness of Yoga and Pilates in reducing the symptoms of stress urinary incontinence among elderly women, for example the amount and frequency of involuntary leaks of urine during coughing, sneezing and physical exertion, compared with standard care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92610 0
Dr Priya Kannan
Address 92610 0
Room ST532
The Hong Kong Polytechnic University

11 Yuk Choi Road
Hung Hom, New Territories
Hong Kong
Country 92610 0
Hong Kong
Phone 92610 0
+85234003277
Fax 92610 0
Email 92610 0
Priya.Kannan@polyu.edu.hk
Contact person for public queries
Name 92611 0
Mr Fung Ka Fai
Address 92611 0
Room ST532
The Hong Kong Polytechnic University

11 Yuk Choi Road
Hung Hom, New Territories
Hong Kong
Country 92611 0
Hong Kong
Phone 92611 0
+85296037900
Fax 92611 0
Email 92611 0
lucas.kf.fung@connect.polyu.hk
Contact person for scientific queries
Name 92612 0
Mr Fung Ka Fai
Address 92612 0
Room ST532
The Hong Kong Polytechnic University

11 Yuk Choi Road
Hung Hom, New Territories
Hong Kong
Country 92612 0
Hong Kong
Phone 92612 0
+85296037900
Fax 92612 0
Email 92612 0
lucas.kf.fung@connect.polyu.hk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results