Clinical trial NCT05474469: Diaphragmatic Breathing With and Without Abdominal Muscles Strength Training Program
Official title: Effects of Diaphragmatic Breathing With and Without Abdominal Muscles Strength Training Program on Pelvic Floor Strength, Endurance and Quality of Life in Postnatal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Muscle Weakness
Endurance
Quality of Life
Keywords: Abdominal Muscles
Breathing Exercises
Exercise
Pelvic Floor
Quality Of Life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 74
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PERFECT scheme questionnaire
timeFrame: 4 Weeks
measure: SF-36 quality of life questionnaire
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Islamic Center Sialkot
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sabiha Arshad, M.Phil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.