NCT05474469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2022

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

July 24, 2022

Last Update Submit

December 13, 2022

Conditions

Keywords

Abdominal MusclesBreathing ExercisesExercisePelvic FloorQuality Of Life

Outcome Measures

Primary Outcomes (2)

  • PERFECT scheme questionnaire

    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

    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

Study Arms (2)

Diaphragmatic breathing in combination with abdominal muscle strengthening exercises

EXPERIMENTAL

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.

Other: Diaphragmatic breathing exercisesOther: Abdominal muscle strengthening exercises

Diaphragmatic breathing Exercises only without abdominal muscle strengthening exercises

ACTIVE COMPARATOR

Active comparator (Group B) will receive diaphragmatic breathing only. 12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.

Other: Diaphragmatic breathing exercises

Interventions

12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.

Diaphragmatic breathing Exercises only without abdominal muscle strengthening exercisesDiaphragmatic breathing in combination with abdominal muscle strengthening exercises

12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.

Diaphragmatic breathing in combination with abdominal muscle strengthening exercises

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostnatal Women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20 to 35 years.
  • Women between 2 to 6 months post-natal.
  • Women with stable somatic state.
  • Women with no cognitive dysfunction.

You may not qualify if:

  • Women with respiratory problems.
  • Women with severe back pain.
  • Patients with any pelvic pathology
  • Patient with any previous neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islamic Center Sialkot

Sialkot, Punjab Province, 51300, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 26329802BACKGROUND
  • 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.

    PMID: 17416924BACKGROUND
  • 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.

    PMID: 22344353BACKGROUND
  • 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.

    PMID: 33606844BACKGROUND
  • 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.

    PMID: 34461383BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sabiha Arshad, M.Phil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2022

First Posted

July 26, 2022

Study Start

January 1, 2022

Primary Completion

August 1, 2022

Study Completion

August 10, 2022

Last Updated

December 15, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations