- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05474469
Diaphragmatic Breathing With and Without Abdominal Muscles Strength Training Program
Effects of Diaphragmatic Breathing With and Without Abdominal Muscles Strength Training Program on Pelvic Floor Strength, Endurance and Quality of Life in Postnatal Women
The postpartum period is excessively weak and have hypotonic abdominal muscles, making the ligaments and connective tissue softer and more elastic. The importance of exercise in the postpartum period is very important in this regard.
This study will be a Randomized control trial used to compare the effects of diaphragmatic breathing with and without abdominal muscles strength training program on pelvic floor strength and endurance and quality of life in postnatal women. Subjects meeting the inclusion and exclusion criteria will be divided into two groups using lottery method. Assessment will be done using PERFECT scheme questionnaire and SF- 36 quality of life questionnaire. Subjects in one group will receive diaphragmatic breathing exercises along with pelvic muscle strength training and subjects in other group will receive only diaphragmatic breathing exercises. Each subject will receive 12 treatment sessions for 4 weeks. Results will be analyzed for any change by using SPSS25.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The postpartum period is excessively weak and have hypotonic abdominal muscles, making the ligaments and connective tissue softer and more elastic. These changes result in anatomical, physiological and biomechanical alterations. Therefore, these factors are responsible for the lack of necessary support for the waist region, pain, disability and negative impact on health-related quality of life. The importance of exercise in the postpartum period is very important in this regard. Postnatal exercises have several benefits such as improving pelvic floor strength and endurance and quality of life and increasing the general well-being, preventing the diastasis of the rectus Abdominis muscle (RAM) increasing cardiovascular endurance and bone mineral density.
This study will be a Randomized control trial used to compare the effects of diaphragmatic breathing with and without abdominal muscles strength training program on pelvic floor strength and endurance and quality of life in postnatal women. Subjects meeting the inclusion and exclusion criteria will be divided into two groups using lottery method. Assessment will be done using PERFECT scheme questionnaire and SF- 36 quality of life questionnaire. Subjects in one group will receive diaphragmatic breathing exercises along with pelvic muscle strength training and subjects in other group will receive only diaphragmatic breathing exercises. Each subject will receive 12 treatment sessions for 4 weeks. Results will be analyzed for any change by using SPSS25.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Sialkot, Punjab, Pakistan, 51300
- Islamic Center Sialkot
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 20 to 35 years.
- Women between 2 to 6 months post-natal.
- Women with stable somatic state.
- Women with no cognitive dysfunction.
Exclusion Criteria:
- Women with respiratory problems.
- Women with severe back pain.
- Patients with any pelvic pathology
- Patient with any previous neurological disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diaphragmatic breathing in combination with abdominal muscle strengthening exercises
Exprimental Group ( Group A) will receive diaphragmatic breathing in combination with abdominal muscle strengthening exercises .12
treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.
|
12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.
12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.
|
|
Active Comparator: Diaphragmatic breathing Exercises only without abdominal muscle strengthening exercises
Active comparator (Group B) will receive diaphragmatic breathing only.
12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.
|
12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PERFECT scheme questionnaire
Time Frame: 4 Weeks
|
The term PERFECT stands for power (or pressure), endurance (E), repetitions (R), rapid contractions (F), and lastly, every contraction timed (ECT).
The Pelvic Floor Muscle Assessment Scheme was created to streamline and explain the process.
This program may provide suggestions for developing patient-specific exercise plans that correspond to the principles of muscle training."
|
4 Weeks
|
|
SF-36 quality of life questionnaire
Time Frame: 4 Weeks
|
Physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) are the eight scales that the SF-36 measures.
Different amounts from each scale do go into the scoring of the PCS and MCS measures.
|
4 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sabiha Arshad, M.phil, Riphah International University
Publications and helpful links
General Publications
- Gursen C, Inanoglu D, Kaya S, Akbayrak T, Baltaci G. Effects of exercise and Kinesio taping on abdominal recovery in women with cesarean section: a pilot randomized controlled trial. Arch Gynecol Obstet. 2016 Mar;293(3):557-65. doi: 10.1007/s00404-015-3862-3. Epub 2015 Sep 2.
- Ashton-Miller JA, DeLancey JO. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci. 2007 Apr;1101:266-96. doi: 10.1196/annals.1389.034. Epub 2007 Apr 7.
- Bernardes BT, Resende AP, Stupp L, Oliveira E, Castro RA, Bella ZI, Girao MJ, Sartori MG. Efficacy of pelvic floor muscle training and hypopressive exercises for treating pelvic organ prolapse in women: randomized controlled trial. Sao Paulo Med J. 2012;130(1):5-9. doi: 10.1590/s1516-31802012000100002.
- Janakiraman B, Gebreyesus T, Yihunie M, Genet MG. Knowledge, attitude, and practice of antenatal exercises among pregnant women in Ethiopia: A cross-sectional study. PLoS One. 2021 Feb 19;16(2):e0247533. doi: 10.1371/journal.pone.0247533. eCollection 2021.
- Oliveira MC, Oliveira M, Silva H, Gomes A, Nascimento G, Marini G, Micussi MT. Evaluation of satisfaction of pelvic floor muscle training isolated and associated with tibial nerve stimulation in women with mixed urinary incontinence: A randomized, single-blinded clinical trial. Eur J Obstet Gynecol Reprod Biol. 2021 Oct;265:60-65. doi: 10.1016/j.ejogrb.2021.06.024. Epub 2021 Jun 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0509
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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