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Effects of Pilates Exercises Versus Pelvic Floor Muscle Exercises Among Elderly Women With Urinary Incontinence

Primary Purpose

Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Shoulder bridge
Clam shell
Scissors
Adductor squeeze
Pelvic clock supine
urine hold and tummy tuck in
Bridging
Split table top
Electrical muscle stimulation
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary incontinence, Older females, Pelvic floor disorders, Urination, Quality of life

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Elderly females from an outpatient setting of Sindh Institute of physical medicine and rehabilitation and civil hospital Karachi.
  • Patients aged ≥60 years.
  • Experienced stress or mixed urinary incontinence symptoms at least 3 times/ week for 3 months or more.

Exclusion Criteria:

  • Have limited mobility (unable to move without crutches, walker, or a cane).
  • Have untreated chronic constipation or have experienced any stool or mucus leakage.
  • Organ prolapse surgery within the last year.
  • In the last 3 months, any active urinary or vaginal infection.
  • Malignancy

Sites / Locations

  • Humera AhmedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pilates exercises

Pelvic floor exercise

Arm Description

The Pilates method's exercises emphasize breathing and the activation of the deep stabilizing muscles of the trunk in coordination with the PFM. The pilates method consists of exercises that emphasize pelvic stability, mobility, and body alignment. PMFE are performed in tandem with breathing, with concurrent trunk muscle recruitment in various positions.

These exercises are intended to strengthen weak perineal and pelvic floor muscles.

Outcomes

Primary Outcome Measures

Change in volume of urine in millilitre on Voiding Diary after 4 weeks
It will be recorded by patient in millilitre in a marked beaker. Increase in millilitre suggests increase in volume of urine.
Change in intensity and frequency of urine leakage on Voiding Diary after 4 weeks
It will be recorded by patient with yes or no option. Increase in ticks on yes options suggests increase in intensity and frequency of urine leakage.
Change in the number of pads on Voiding Diary after 4 weeks.
It will be recorded by patient with the symbol P if yes and blank if No. Increase in written symbol P suggests increased number of pads.
Change in frequency and grading of urgency on Voiding Diary after 4 weeks
It will be recorded by patient with grades 0=little, +=mild, ++=extreme urgency. The more the score the worst the urinary incontinence is.
Change in urine incontinence on Stamey's incontinence scoring system after 4 weeks
It is based on the patient's incontinence history alone. It will be graded from 0=no incontinence to 3=total incontinece at all times.The higher the score the more severity of urinary incontinence is

Secondary Outcome Measures

Change in Quality of life on Quality of life measures questionnaire scores after 4 weeks
All the participants will complete an incontinence-related quality of life questionnaire to assess the quality of life of patients suffering from urinary incontinence.Higher the scores, the higher will be quality of life.

Full Information

First Posted
April 18, 2022
Last Updated
February 15, 2023
Sponsor
Dow University of Health Sciences
Collaborators
The Institute of Physical Medicine and Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT05341778
Brief Title
Effects of Pilates Exercises Versus Pelvic Floor Muscle Exercises Among Elderly Women With Urinary Incontinence
Official Title
Effects of Pilates Exercises Versus Pelvic Floor Muscle Exercises Among Elderly Women With Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
Collaborators
The Institute of Physical Medicine and Rehabilitation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare the effects of Pilates exercises versus pelvic floor muscle exercises among elderly women with urinary incontinence. The study is a single-blinded randomized clinical trial. 70 patients(calculated through PASS version 15 software) will be selected. Subjects will be screened whether they met inclusion and exclusion criteria. The participants for this study will be elderly women with urinary incontinence. The participants will be recruited from SIPMR and Civil hospital Karachi. The initial assessment will be done by Medical Consultant. Patients must fulfill inclusion criteria. Consent must be taken from each patient and samples will be collected in the given time frame and patients will be randomly assigned(through a randomization sheet) to the treatment groups. Treatment group 1 will be doing Pilates exercises and treatment group 2 will be doing Pelvic floor muscle exercises. EMS will be given to both treatment groups. A voiding diary, Stamey's urinary incontinence system, and IQOL questionnaire will be used at baseline assessment and at the end of treatment sessions. 12 treatment sessions will be given, 3 visits each week for 4 weeks. The data will be analyzed on SPSS version 21. : Non-probability purposive sampling technique will be used for selecting individuals. Percentages and frequencies will be calculated for categorical variables and parametric and nonparametric tests will be applied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Urinary incontinence, Older females, Pelvic floor disorders, Urination, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be blinded to the type of treatment provided to the patients.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilates exercises
Arm Type
Experimental
Arm Description
The Pilates method's exercises emphasize breathing and the activation of the deep stabilizing muscles of the trunk in coordination with the PFM. The pilates method consists of exercises that emphasize pelvic stability, mobility, and body alignment. PMFE are performed in tandem with breathing, with concurrent trunk muscle recruitment in various positions.
Arm Title
Pelvic floor exercise
Arm Type
Active Comparator
Arm Description
These exercises are intended to strengthen weak perineal and pelvic floor muscles.
Intervention Type
Other
Intervention Name(s)
Shoulder bridge
Intervention Description
The shoulder bridge is great for, strengthening your gluteal muscles, quadriceps, hamstrings, pelvic floor, abdominals and back muscles; most notably the tiny ones which control movement of each individual vertebrae and can weaken after episodes of back pain.
Intervention Type
Other
Intervention Name(s)
Clam shell
Intervention Description
Scissors is an abdominal exercise that strengthens the transverse abdominals, helping flatten your belly and strengthen your entire core. Scissors is not only a core strength move, but it is also a great stretch for your hamstrings and your lower back.
Intervention Type
Other
Intervention Name(s)
Scissors
Intervention Description
Scissors is an abdominal exercise that strengthens the transverse abdominals, helping flatten your belly and strengthen your entire core. Scissors is not only a core strength move, but it is also a great stretch for your hamstrings and your lower back.
Intervention Type
Other
Intervention Name(s)
Adductor squeeze
Intervention Description
Adductor Squeeze exercise The SQ exercise is an isometric hip adduction exercise with the player holding a ball between their knees.
Intervention Type
Other
Intervention Name(s)
Pelvic clock supine
Intervention Description
The pelvic clock is a brilliant exercise to help achieve flexibility and strength in the lower back, pelvic floor, and core-in order to prevent pain and injury.
Intervention Type
Other
Intervention Name(s)
urine hold and tummy tuck in
Intervention Description
During tummy tuck patients are able to strategically tighten and reinforce the muscles around the pelvic floor, urethra, and other structures. This increased strength and support greatly reduces stress urinary incontinence
Intervention Type
Other
Intervention Name(s)
Bridging
Intervention Description
A bridge exercise isolates and strengthens your gluteus (butt) muscles - the gluteus maximus, medius and minimus - and hamstrings, which are the main muscles that make up the posterior chain. It is done by lying on your back with your knees bent, feet flat on the ground and at a comfortable distance from your butt.
Intervention Type
Other
Intervention Name(s)
Split table top
Intervention Description
To strengthen your abs, shoulders, arms and legs. The most important part of this move is to contract your abs fully before you start to lower your hips
Intervention Type
Device
Intervention Name(s)
Electrical muscle stimulation
Intervention Description
Electric stimulation works by mimicking the natural way by which the body exercises its muscles. The electrodes attached to the skin deliver impulses that make the muscles contract. It is beneficial in increasing the patient's range of motion and improves the circulation of the body.
Primary Outcome Measure Information:
Title
Change in volume of urine in millilitre on Voiding Diary after 4 weeks
Description
It will be recorded by patient in millilitre in a marked beaker. Increase in millilitre suggests increase in volume of urine.
Time Frame
baseline and after 4 weeks
Title
Change in intensity and frequency of urine leakage on Voiding Diary after 4 weeks
Description
It will be recorded by patient with yes or no option. Increase in ticks on yes options suggests increase in intensity and frequency of urine leakage.
Time Frame
baseline and after 4 weeks
Title
Change in the number of pads on Voiding Diary after 4 weeks.
Description
It will be recorded by patient with the symbol P if yes and blank if No. Increase in written symbol P suggests increased number of pads.
Time Frame
baseline and after 4 weeks
Title
Change in frequency and grading of urgency on Voiding Diary after 4 weeks
Description
It will be recorded by patient with grades 0=little, +=mild, ++=extreme urgency. The more the score the worst the urinary incontinence is.
Time Frame
baseline and after 4 weeks
Title
Change in urine incontinence on Stamey's incontinence scoring system after 4 weeks
Description
It is based on the patient's incontinence history alone. It will be graded from 0=no incontinence to 3=total incontinece at all times.The higher the score the more severity of urinary incontinence is
Time Frame
baseline and after 4 weeks
Secondary Outcome Measure Information:
Title
Change in Quality of life on Quality of life measures questionnaire scores after 4 weeks
Description
All the participants will complete an incontinence-related quality of life questionnaire to assess the quality of life of patients suffering from urinary incontinence.Higher the scores, the higher will be quality of life.
Time Frame
baseline and after 4 week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
participant eligibility will be based on self-representation of gender identity.
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elderly females from an outpatient setting of Sindh Institute of physical medicine and rehabilitation and civil hospital Karachi. Patients aged ≥60 years. Experienced stress or mixed urinary incontinence symptoms at least 3 times/ week for 3 months or more. Exclusion Criteria: Have limited mobility (unable to move without crutches, walker, or a cane). Have untreated chronic constipation or have experienced any stool or mucus leakage. Organ prolapse surgery within the last year. In the last 3 months, any active urinary or vaginal infection. Malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Humera Ahmed, DPT
Phone
03352976633
Email
sweethummi12@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rabail Rani Soomro, MSPT
Phone
03341348099
Email
rabail.physio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aftab Ahmed Mirza Baig, MSAPT
Organizational Affiliation
Sindh Institute of Physical Medicine and Rehabilitation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Humera Ahmed, DPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rabail Rani Soomro, MSPT
Organizational Affiliation
Sindh Institute of Physical Medicine and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Humera Ahmed
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aftab Ahmed Mirza Baig, MSAPT
Phone
+923002739920
Email
ab.dptrm@gmail.com
First Name & Middle Initial & Last Name & Degree
Rabail Rani Soomro, MSPT
Phone
+923132054425
Email
rabail.physio@gmail.com
First Name & Middle Initial & Last Name & Degree
Humera Ahmed, DPT

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD yet.

Learn more about this trial

Effects of Pilates Exercises Versus Pelvic Floor Muscle Exercises Among Elderly Women With Urinary Incontinence

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