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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05341778
• Other study ID #: HAhmed
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: February 2023
• Source: Dow University of Health Sciences
• Contact: Humera Ahmed, DPT
• Phone: 03352976633
• Email: sweethummi12[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Other:
• Shoulder bridge
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.
• Clam shell
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.
• Scissors
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.
• Adductor squeeze
Adductor Squeeze exercise The SQ exercise is an isometric hip adduction exercise with the player holding a ball between their knees.
• Pelvic clock supine
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.
• urine hold and tummy tuck in
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
• Bridging
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.
• Split table top
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

Device:
• Electrical muscle stimulation
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.

Locations

Country	Name	City	State
Pakistan	Humera Ahmed	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Dow University of Health Sciences	The Institute of Physical Medicine and Rehabilitation

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and after 4 weeks
Primary	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.	baseline and after 4 weeks
Primary	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.	baseline and after 4 weeks
Primary	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.	baseline and after 4 weeks
Primary	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	baseline and after 4 weeks
Secondary	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.	baseline and after 4 week